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07 MDCG 2020-7 Guidance on PMCF Plan Template.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-7
1
MDCG 2020-7
Post-market clinical follow-up (PMCF) Plan Template
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU)
2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European
Commission.The document is not a European Commission document and it cannot be regarded as reflecting the official position of the
European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European
Union can give binding interpretations of Union law.
Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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Post-market clinical follow-up (PMCF) Plan Template
A guide for manufacturers and notified bodies
Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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Contents
Introduction ........................................................................................................................................................................................................................................... 4
Post-market clinical follow-up plan Template .................................................................................................................................................................................. 5
Section A. Manufacturer contact details ....................................................................................................................................................................................... 5
Section B. Medical Device description and specification .......................................................................................................................................................... 6
Section C. Activities related to PMCF: general and specific methods and procedures ........................................................................................................ 7
Section D. Reference to the relevant parts of the technical documentation .......................................................................................................................... 9
Section E. Evaluation of clinical data relating to equivalent or similar devices .................................................................................................................... 10
Section F. Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance document(s) ............................. 11
Section G. – Estimated date of the PMCF evaluation report .................................................................................................................................................. 12
Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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Introduction
The Medical Device Regulation (EU) 2017/745 (MDR) considers the post-market clinical follow-up (PMCF) as a continuous process that
updates the clinical evaluation and that shall be addressed in the manufacturer’s post-market surveillance (PMS) plan. The MDR
reinforces the PMCF process by the manufacturer, devoting part B of Annex XIV to it and providing a set of requirements for developing
a plan, necessary to implement PMCF.
A PMCF plan shall specify the methods and procedures set up by the manufacturer, to proactively collect and evaluate clinical data from
the use in or on humans of a CE marked medical device, placed on the market or put into service within its intended purpose, as referred
to in the relevant conformity assessment procedure.
The aim of the PMCF plan is:
confirming the safety1 and performance, including the clinical benefit if applicable, of the device throughout its expected lifetime;
identifying previously unknown side-effects and monitor the identified side-effects and contraindications;
identifying and analysing emergent risks on the basis of factual evidence;
ensuring the continued acceptability of the benefit-risk ratio, referred to in Section 1 and 9 of Annex I in the MDR;
identifying possible systematic misuse or off-label use of the device, with a view to verifying that the intended purpose is correct.
The PMCF plan shall be part of the post-market surveillance plan.
The findings of the PMCF shall be analysed by the manufacturer who shall document the results in a PMCF evaluation report. The
PMCF evaluation report shall be part of the clinical evaluation report and the technical documentation. The adequateness of the PMCF
plan and its application is subject to assessment by the notified body. The notified body’s assessment of the clinical evaluation shall also
cover the manufacturer’s procedures and documentation of the PMCF, as well as the justification in relation to non-performance of
PMCF.
The purpose of the present template is to guide manufacturers in complying with the requirements of the MDR with respect to the
compilation of the PMCF plan. This would assist manufacturers in a harmonised and complete presentation of post market clinical data
and facilitate the activity of notified bodies and competent authorities in finding the information in an organised format.
1 The confirmation of the safety includes the acceptability of identified risks and particularly residual risks. Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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Post-market clinical follow-up plan Template
PMCF plan number:
PMCF plan date:
PMCF plan version:
Revision history
Rev Revision date Description of change Revised by
Section A. Manufacturer contact details
Legal manufacturer name:
Address:
SRN:
Person responsible for regulatory compliance:
E-mail:
Phone:
Fax:
Authorised representative (if applicable):
Address:
Contact person:
E-mail:
Phone:
Fax:
Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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Section B2. Medical Device description and specification
Product or trade name:
Model and type:
General description of the device:
Intended purpose3:
Intended users
Basic UDI-DI:
Intended patient population:
Medical condition(s)4:
Indications:
Contraindications:
Warnings:
List and description of any variants and/or configurations covered by this plan:
List of any accessories covered by this plan:
Certificate number (if available):
CND code(s)5:
Class:
Classification rule:
2 MDR, Annex II, 1,1.
3 Intended purpose means the use for which a device is intended according to the data supplied by the manufacturer on the label in the instructions for use or in promotional or
sales materials or statements and as specified by the manufacturer in the clinical evaluation (MDR, Article 2(12)).
4 It refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device
5 Per article 26 of MDR. Medical Device
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Expected lifetime:6
Novel product: ☐ yes ☐ no
Novel related clinical procedure: ☐ yes ☐ no
Explanation of any novel features:
Section C. Activities related to PMCF: general and specific methods and procedures
In this section it is expected to describe the different activities that will be conducted in post-market, including general and specific methods / procedures
to conduct in relation to the product covered by the scope of PMCF, also the aim of each activity described and the rational for the appropriateness of
the chosen general and specific methods to achieve those objectives as well as the known limitations of the planned activities such as for example
incomplete follow up, missing data and so on. The timelines of those activities shall be also defined quarterly or at least yearly.
Here are some examples of different activities related to PMCF:
A manufacturer device registry (specific for the type of device or the group of the medical devices the product belongs to) can be indicated
together with a description and a summary of the plan. A pre-specification of what quality and quantity data – based on the risk of the device(s)
and the associated accessories – to be collected and analysed shall be included. Any possible evaluation of suitable national public registries
with clinical data on the manufacturer’s own device and/or on similar devices could be specified in this section, identifying the expected quantity
and quality of data to be gathered and the search protocols to be adopted.
PMCF studies planned could be indicated in this section, together with a summary of the plan including the design, sample size, the endpoints,
the inclusion/exclusion criteria (e.g. extended follow up of patients included in the pre-market clinical investigations, new clinical investigations
within the intended use, retrospective studies). In case of implantable devices and class III devices where clinical investigations have not been
performed pursuant to Article 61 (4), the PMCF plan shall include post market studies to confirm the safety and performance of the device.
Planned Real-world evidence (RWE) analyses could be indicated in this section, together with a summary of the plan including the design,
sample size, the endpoints, and analysis population. The real-world data (RWD) from which these analyses are based on should be of sufficient
quality and come from reliable data sources.
Surveys planned to collect information about the use of the concerned medical device could be described.
Each activity will be developed in a different subsection (e.g. C.1, C.2, …), and for which the manufacturer will:
6 The expected lifetime is to be defined during the design input phase by considering the current state of the art for a specific intended use and indication of a device. Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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Define where the need of conducting the PMCF activity is coming from (requested by notified body, clinical evaluation report, PMS, risk
management report, previous PMCF report, etc…)
Provide the description of activity, and if it is a general or specific procedure / method.
Define the aim of this activity:
o confirming the safety of the medical device
o confirming the performance of the medical device
o identifying previously unknown side-effects (related to the procedures or to the medical devices).
o monitoring the identified side-effects and contraindications
o identifying and analysing emergent risks
o ensuring the continued acceptability of the benefit-risk ratio
o identifying possible systematic misuse or off-label use of the device
Describe the different procedures which will be used as part of PMCF:
o screening of scientific literature and other sources of clinical data
o post-market studies
o collecting data in registries
o survey from health care professional
o survey from patients/users
o review of case reports which may reveal misuse or off-label use
Describe the rationale for the appropriateness of the chosen methods/procedures, including:
o the justification for sample size, timescales and endpoints
o justification for comparator, on the basis of intended purpose and state of the art
o justification of the study design on the basis of all of the above, and why it is sufficient to ensure representative patient populations and
provide for adequate controls on sources of bias (an evaluation of the potential sources of bias should form part of this)
o a statistical justification for the expected quality of outcomes, and justification for why this is satisfactory in light of the residual risks. This
is an important consideration. For example, retrospective surveys with no justification other than “this should demonstrate the expected
quality of evidence that we require,” but without showing a statistical rationale, are not acceptable.
Provide the timelines of the activity. A detailed and adequately justified time schedule for PMCF activities, such as the analysis of PMCF data and
reporting, shall be described. Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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A summary table of the different PMCF activities foreseen by the manufacturer is provided below:
Number
of
activity Description of activity Aim of the activity
Rationale and known
limitations of the activity Timelines of the activity
Section D. Reference to the relevant parts of the technical documentation
In this section the manufacturer is required to include references to the relevant information from the clinical evaluation report and from the risk
management file, which need to be analysed, followed up, and evaluated in this plan. As an alternative, the manufacturer is required to state that there is
no relevant information from the clinical evaluation report and/or from the risk management file to be considered in this plan.
Clinical Evaluation Report (date and version)
Relevant information to be further analysed and monitored:
-
-
-
Risk Management File (date and version)
Relevant information to be further analysed and monitored: Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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-
-
-
☐ No relevant information from the clinical evaluation report to be considered in this plan
☐ No relevant information from the risk management file to be considered in this plan
Section E. Evaluation of clinical data relating to equivalent or similar7 devices
The manufacturer shall gather in this section information regarding equivalent / similar devices for which clinical data will be further evaluated and
presented in the PMCF report.
Please note that PMCF data intended to demonstrate continuing safety and performance should be sourced from the device under evaluation.
Data from equivalent or similar devices may be used, for example to update the information relating to the state of the art, to identify and further assess
relevant safety outcomes etc.
The selected devices shall be consistent throughout the technical documentation. Indicate whether the selected device is demonstrated to be equivalent
or is a similar device. For each device listed, a clear reference to the pertinent parts of the CER can be made.
The following items of each equivalent and/or similar devices would be at least provided, in a table format:
7 Section 5, MDCG 2020-5 Clinical Evaluation – Equivalence, A guide for manufacturers and notified bodies. Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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Product name of
equivalent / similar
device Intended purpose Intended users Intended patient population Medical condition Indication Reference to clinical
data evaluation in
the CER ( date,
version and location in
the text)
Section F. Reference to any applicable common specification(s), harmonized standard(s) or applicable guidance
document(s)
Common specification(s) to comply with, if applicable:
(Title, date and version)
Harmonised standards to apply, if applicable
(Title, date and version)
Guidance on PMCF, if applicable Medical Device
Medical Device Coordination Group Document MDCG 2020-7
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(Title, date and version)
Section G. – Estimated date of the PMCF evaluation report
When the manufacturer plans to have the first report. The timelines shall be defined quarterly or at least yearly. |
06 MDCG 2020-6 Guidance on Sufficient Clinical Evidence for Legacy Devices.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-6
MDCG 2020-6
Regulation (EU) 2017/745: Clinical evidence needed for
medical devices previously CE marked under
Directives 93/42/EEC or 90/385/EEC
A guide for manufacturers and notified bodies
April 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG)
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European
Commission.The document is not a European Commission document and it cannot be
regarded as reflecting the official position of the European Commission. Any views
expressed in this document are not legally binding and only the Court of Justice of the
European Union can give binding interpretations of Union law.
Page 2 of 22
Regulation (EU) 2017/745: Clinical evidence needed for medical devices
previously CE marked under Directives 93/42/EEC or 90/385/EEC
A guide for manufacturers and notified bodies
Page 3 of 22
Table of contents
1. Definitions ...................................................................................................................................................... 4
1.1. Terms defined in MDR Article 2 .................................................................................. 4
1.2. Additional terms not defined in MDR Article 2 ............................................................ 4
2. Reference documents ............................................................................................................................... 6
3. Scope ................................................................................................................................................................ 6
4. Introduction and context ......................................................................................................................... 7
5. General aspects ............................................................................................................................................ 8
6. Guidance on specific aspects of clinical evaluation for legacy devices ........................... 10
6.1. Annex XIV Part A Section 1a: Establish or update a clinical evaluation plan .............. 10
6.2. Annex XIV Part A Section 1b: Identify available clinical data .................................... 11
6.2.1. Pre-market sources of clinical data ...................................................................... 12
6.2.2. Post-market sources of clinical data ..................................................................... 12
6.3. Annex XIV Part A Section 1c: Appraisal of the clinical data ...................................... 12
6.4. Annex XIV Part A Section 1d: Generation of new clinical data .................................. 13
6.5. Annex XIV Part A Section 1e: Analysis of the clinical data ........................................ 14
Appendix I - Sections of MEDDEV 2.7/1 rev. 4 which are still relevant under the MDR for
the application of this guidance ................................................................................................................. 18
Appendix II – Clinical Evaluation Plan for Legacy Devices .............................................................. 19
Appendix III – Suggested hierarchy of clinical evidence for confirmation of conformity
with relevant GSPRs under the MDR ........................................................................................................ 20
Page 4 of 22
This guidance document is not legally binding. It has been put together following
contribution from national competent authorities, industry and relevant stakeholders and
it should therefore be recognised as best practice. It also intends to support a harmonised
approach with respect to clinical data providing sufficient clinical evidence necessary to
demonstrate conformity with the relevant General Safety and Performance Requirements
(GSPR) across European Union Member States.
1. Definitions
1.1. Terms defined in MDR Article 2
The following terms are used as defined in the Medical Device Regulation (EU) 2017/745
(MDR):
‘performance’;1
‘risk’;2
‘intended purpose’3
‘benefit-risk determination’;4
‘clinical evaluation’;5
‘clinical investigation’;6
‘clinical data’;7
‘clinical evidence’;8
‘clinical performance’;9
It should be noted that clinical performance may arise from either ‘direct or indirect
medical effects’ ‘leading to a clinical benefit for patients’; see comments for
relevance to clinical benefit below
‘clinical benefit’.10
It should be noted that clinical benefits may be either direct or indirect; for example
devices such as guidewires may assist other medical devices in achieving their
intended purpose, without having a direct therapeutic or diagnostic function
themselves.
‘generic device group’.11
1.2. Additional terms not defined in MDR Article 2
Additional terms which are not explicitly defined in Article 2 of the MDR, but which are
essential to evaluation of benefit-risk and clinical evaluation conclusions:
1 MDR, Article 2(22).
2 MDR, Article 2(23).
3 MDR, Article 2(12).
4 MDR, Article 2(24).
5 MDR, Article 2(44).
6 MDR, Article 2(45).
7 MDR, Article 2(48).
8 MDR, Article 2(51).
9 MDR, Article 2(52).
10 MDR, Article 2(53).
11 MDR, Article 2(7).
Page 5 of 22
‘legacy devices’: this is considered to include all devices previously CE marked
under the European Medical Devices Directive 93/42/EEC (MDD) or Active
Implantable Medical Devices Directive 90/385/EEC (AIMDD)
‘well-established technology’: this terminology is used in Article 52(5) and Article
61(8) of the MDR, but is not defined in these articles. The term is not restricted to
the devices listed in Article 61(6b); Article 61(8) explicitly states that this includes
devices similar to the exempted devices listed in Article 61(6b), which might be
added to that list in future. The common features of the devices which are well-
established technologies are that they all have:
o relatively simple, common and stable designs with little evolution;
o their generic device group has well-known safety and has not been
associated with safety issues in the past;
o well-known clinical performance characteristics and their generic device
group are standard of care devices where there is little evolution in
indications and the state of the art;
o a long history on the market.
Therefore, any devices that meet all these criteria may be considered “well-
established technologies”.
‘scientific validity’, ‘scientifically valid’: this terminology is used in the MDR in
reference to clinical data planning, evaluation and conclusions12. Clinical
evaluations must follow a “defined and methodologically sound procedure”13, for
which expectations of scientific validity are implicit. Embedded in the term
‘scientific validity’ are concepts including adequacy of study design and controls
for bias, appropriateness and relevance of research questions, adequacy of
sample sizes and statistical analyses, completeness of data, adequacy of follow
up period, and appropriateness of conclusions on the basis of objective evidence.
Section 9.3.1 of MEDDEV 2.7/1 rev. 4 provides guidance for the evaluation of
methodological quality and scientific validity under the MDD/AIMDD which are
equally valid under the MDR which can be considered to apply when referencing
‘scientific validity’ in this guidance.
‘level of clinical evidence’: this terminology is used in the MDR with respect to
requirements for demonstration of conformity with the relevant GSPR and overall
benefit-risk14. It is understood to encompass the amount and quality of evidence
(i.e. its characterisation by quality, quantity, completeness and statistical validity,
etc.) required to demonstrate safety, performance and the benefit-risk conclusion
of a medical device. It should not be confused with the term ‘levels of evidence’
(as used in evidence-based medicine) which is used to rank study designs, and is
only a part of the concept ‘level of clinical evidence’. Regarding the assessment of
the level of clinical evidence for the device in question, see sections 6.3 and 6.5d
of this document.
‘state of the art’: IMDRF/GRRP WG/N47 provides the following definition:
Developed stage of current technical capability and/or accepted clinical practice in
regard to products, processes and patient management, based on the relevant
consolidated findings of science, technology and experience.
12 MDR Annex XV, Chapter I, Article 2(2.1) and (2.6).
13 MDR Article 61(3).
14 MDR Article 61(1), Annex IX section 5.1.
Page 6 of 22
Note: The state-of-the-art embodies what is currently and generally accepted as
good practice in technology and medicine. The state-of-the-art does not
necessarily imply the most technologically advanced solution. The state-of-the-art
described here is sometimes referred to as the “generally acknowledged state-of-
the-art
‘intended use’: The MDR defines ‘intended purpose’, but not ‘intended use’.
‘intended use’ should be considered to have the same meaning as ‘intended
purpose’.
‘indication’, ‘indication for use’: refers to the clinical condition that is to be
diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced,
modified or controlled by the medical device. It should be distinguished from
‘intended purpose/intended use’, which describes the effect of a device. All devices
have an intended purpose/intended use, but not all devices have an indication (e.g.
medical devices with an intended purpose of disinfection or sterilisation of
devices).
‘similar device’: devices belonging to the same generic device group. The MDR
defines this as a set of devices having the same or similar intended purposes or a
commonality of technology allowing them to be classified in a generic manner not
reflecting specific characteristics15.
2. Reference documents
This document provides facilitative guidance to the requirements of MDR Chapter VI and
Annex XIV, and references the following MDD/AIMDD guidance documents:
MEDDEV 2.7/1 rev. 4: Clinical Evaluation: A Guide for Manufacturers and Notified
Bodies under Directives 93/42/EEC and 90/385/EEC
MEDDEV 2.12/2 rev 2: Post Market Clinical Follow-Up Studies: A Guide for
Manufacturers and Notified Bodies
3. Scope
This document seeks to provide guidance for clinical data providing sufficient clinical
evidence necessary to demonstrate conformity with the relevant GSPR, as per Article
61(1) MDR, for legacy devices CE marked with respect to Directives 93/42/EEC (MDD)
or 90/385/EEC (AIMDD).
This document aims to provide guidance for manufacturers and notified bodies to prepare
for the conformity assessment procedure according to the MDR.
This document does not provide comprehensive guidance with respect to the process or
methodology relating to clinical evaluation. It is general and not restricted to any particular
device technology or risk class. Following on from the principles described in Section 3
however, special attention is given to those described in Article 61(6).
15 MDR, Article 2(7).
Page 7 of 22
4. Introduction and context
This section is intended to provide an introduction and context, and not to modify the
interpretation of the MDR.
MDR Article 61(1) states:
Confirmation of conformity with relevant general safety and performance
requirements set out in Annex I under the normal conditions of the intended use of
the device, and the evaluation of the undesirable side-effects and of the
acceptability of the benefit-risk ratio referred to in Sections 1 and 8 of Annex I, shall
be based on clinical data providing sufficient clinical evidence, including where
applicable relevant data as referred to in Annex III.
The manufacturer shall specify and justify the level of clinical evidence necessary
to demonstrate conformity with the relevant general safety and performance
requirements. That level of clinical evidence shall be appropriate in view of the
characteristics of the device and its intended purpose.
To that end, manufacturers shall plan, conduct and document a clinical evaluation
in accordance with this Article and Part A of Annex XIV.
MDR Article 61(4) states that clinical investigations shall be performed for Class III and
implantable devices, but distinct exemptions from this requirement are identified both in
this article and in Articles 61(5) and 61(6). The common theme of these exempted devices
is that they have been previously marketed (Article 61(6)) or have been demonstrated to
be equivalent to devices previously marketed (Article 61(5)).
Article 61(6a and b) further distinguishes between legacy devices (Article 61(6a)) which
have been previously marketed under 93/42/EEC or 90/385/EEC and a specific subset
of well-established technologies (WET) (Article 61(6b)).
The following should be noted:
all such exemptions from clinical investigations require that the clinical evaluation
is based on “sufficient clinical data”;
the basic clinical evaluation requirements for the legacy devices described in
Article 61(6a) and the devices of Article 61(6b) are the same: “sufficient clinical
data” and compliance to common specifications where these exist. The distinction
between the two is that the devices listed in Article 61(6b) are not explicitly required
to have had prior certification under the Directives to be exempted from the
requirement for clinical investigations that otherwise apply to Class III and
implantable devices;
both the Directives and the MDR require the quantity and quality of clinical data to
be sufficient to demonstrate safety, performance and the acceptability of the
benefit-risk ratio: both the Directives and the MDR require clinical evidence to be
sound and the conclusions derived from this evidence to be scientifically valid.
Article 61(10)16 allows for the use of non-clinical data for demonstration of conformity with
GSPRs:
Without prejudice to paragraph 4,where the demonstration of conformity with
general safety and performance requirements based on clinical data is not deemed
16 See MDCG guidance on the CEAR template for notes related to use of Article 61(10).
Page 8 of 22
appropriate, adequate justification for any such exception shall be given based on
the results of the manufacturer's risk management and on consideration of the
specifics of the interaction between the device and the human body, the clinical
performance intended and the claims of the manufacturer.
Article 61(10) cannot be applied to Class III or implantable devices. In exceptional cases
Article 61(10) may be applied for all other device classifications.
5. General aspects
“Sufficient clinical evidence” is not defined in the MDR. The definition of “clinical evidence”
itself contains the word ”sufficient” but it is related to the amount and quality of the clinical
data and the clinical evaluation results which “allow a qualified assessment of whether
the device is safe and achieves the intended clinical benefits when used as intended by
the manufacturer”.17 Sufficient clinical evidence is also mentioned in the MDR Article 61
where it is provided that the confirmation of conformity with the relevant GSPR shall be
based on sufficient clinical evidence. Therefore, “sufficient clinical evidence” is
understood as “the present result of the qualified assessment which has reached the
conclusion that the device is safe and achieves the intended benefits”. It is important to
note that clinical evaluation is a process where this qualified assessment has to be done
on a continuous basis.
Compared to Directives 93/42/EEC and 90/385/EEC, MDR provides greater detail and
additional requirements with respect to the process of clinical evaluation, for the purpose
of confirmation of conformity with relevant GSPR. The generation of clinical data and their
evaluation providing sufficient clinical evidence is part of a lifecycle approach to medical
devices.
The MDR reinforces a number of important factors which are relevant to clinical
evaluation. This includes:
Consideration of available alternative treatment options is required for the
confirmation of the acceptability of the benefit-risk ratio.18
The acceptability of the benefit-risk ratio must be based upon clinical data
providing sufficient clinical evidence including where applicable relevant data from
post-market surveillance.19
The term “clinical evidence” is introduced and the level of clinical evidence
must be specified and justified by the manufacturer, taking the characteristics of
the device and the intended purpose into account.20
The incorporation of post market surveillance (PMS) data in particular the
post-market clinical follow-up (PMCF) data into the process of clinical evaluation.21
Manufacturers are required to establish a post-market surveillance plan in
accordance with Annex III of the MDR and the clinical data arising from this PMS
shall be incorporated into the clinical evaluation.
The definition of equivalence is now included in the text of the MDR,22 and the
process to demonstrate equivalence is defined23.
17 MDR, Article 2(51).
18 MDR, Article 61(3)(c).
19 MDR, Article 61(1) and Annex III.
20 MDR, Article 61(1).
21 MDR, Article 61(1) and (11).
22 MDR, Annex XIV, Part A, section 3.
23 MDCG 2020-5 Clinical Evaluation – Equivalence, A guide for manufacturers and notified bodies.
Page 9 of 22
A definition of “clinical data” is provided.24
When it comes to the first MDR conformity assessment of a legacy device the pre-market
and post-market clinical data generated for the purpose of MDD/AIMDD can be taken into
account. As requirements and guidance developed over time, it is not necessarily the
case that the clinical data used for conformity assessment under the Directives is clinical
data providing sufficient clinical evidence for the purpose of MDR requirements. Legacy
devices which have been placed on the market have been subjected to conformity
assessment and therefore are presumed to have been supported by clinical data25. Post-
market clinical data together with the clinical data generated for the conformity
assessment under the MDD/AIMDD will be the basis of the clinical evaluation process for
legacy devices under the MDR.
During the period of validity of the MDD/AIMDD certificates, the MDR requirements for
the PMS apply from the MDR date of application. Legacy devices are therefore not
exempted from the additional requirements in MDR concerning PMS, including PMCF.
PMS data and clinical evaluation plans and reports need to be produced and updated.
The MDR compliant clinical evaluation for a legacy device must contain the identification
of available clinical data as well as their appraisal / analysis / evaluation and shall lead to
a demonstration of conformity to the MDR GSPR based on clinical data providing
sufficient clinical evidence as part of a lifecycle approach.
The European Commission guidance MEDDEV 2.12/2 regarding PMCF studies notes
different instances where a PMCF study may have been justified:26
Route chosen for clinical evaluation : where CE marking for legacy devices was
based upon equivalence, PMCF studies may have been necessary. The European
Commission guidance MEDDEV 2.12/2 regarding PMCF also notes that in the
case that clinical evaluation was based exclusively on clinical data from equivalent
devices for initial conformity assessment, the certifying notified body shall verify
that PMCF studies have been conducted,27 in accordance with the relevant
provisions of the Directives.28
Device related factors : There are a number of device-related factors where
PMCF studies may have been necessary.29
When assessing the conformity of legacy devices under the MDR, it is important to verify
whether PMCF studies considered necessary under the MDD/AIMDD (and where
applicable, during the transition period, under the MDR), have been appropriately
conducted, and results are taken fully into account for in the clinical evaluation for the
conformity assessment under MDR.
Guidance on the general process of conducting clinical evaluation is also available in the
MEDDEV 2.7/1 rev. 4. This guidance was written with respect to the MDD and AIMDD to
provide practical guidance on several scientific and clinical aspects that are relevant for
conducting clinical evaluation. However only the text of the MDR is authentic in law,
sections relevant to the MDR are listed in Appendix I to this document.
24 MDR, Article 2(48).
25 Except where non-clinical testing were demonstrated to be adequate (MDD, Annex X, 1.1(d); AIMD, Annex 7, 1.5).
26 MEDDEV 2.12/2, section 5 https://ec.europa.eu/growth/sectors/medical-devices/current-directives/guidance_en
27 MEDDEV 2.12/2, section 8.
28 Annex II.4, Annex II.7, Annex III, Annex V.6 and Annex VI.6 of Directive 93/42/EEC and Annex II.4, Annex II.7, Annex III and Annex
V.6 of Directive 90/385/EEC.
29 MEDDEV 2.12/2, section 5.
Page 10 of 22
6. Guidance on specific aspects of clinical evaluation for legacy devices
Sections 6.1 – 6.5 below provide guidance on each stage of the clinical evaluation
process of MDR Annex XIV Part A Section 1.
6.1. Annex XIV Part A Section 1a: Establish or update a clinical evaluation plan30
Manufacturers are required to document a clinical evaluation plan to meet the
requirements of MDR Annex XIV Section 1a.
Premarket elements of the plan as described in the final indent of MDR Annex XIV Section
1a (first-in-man studies, feasibility and pilot studies) are not generally relevant to legacy
devices which are unchanged in design or indications. However, the context for the plan
as described in indents 1-7 and the basis for the PMCF as described in indent 8 of MDR
Annex XIV Section 1a are considered relevant and necessary for demonstration of
compliance to the MDR. Appendix II of this guidance document suggests a minimum
content for clinical evaluation plans for legacy devices. Further advice regarding specific
sub-indents of MDR Annex XIV Section 1a are provided below.
a. Identification of the relevant GSPRs (indent 1 of MDR Annex XIV Section 1a):
clinical evaluation planning under the Directives required an identification of the
relevant Essential Requirements (ER) for which demonstration of conformity
required clinical data. The manufacturer should conduct an analysis with respect
to the GSPRs of the MDR, to determine if additional data to support the clinical
evidence are required to meet additional MDR requirements. This could be
achieved either through a gap analysis with respect to new MDR requirements, or
by creation of an entirely new analysis for the MDR. As noted in Section 3, Article
61(10) cannot be applied to Class III or implantable devices, but may be applied
to some or all requirements for confirmation of conformity with relevant GSPRs for
all other device classifications if adequately justified.
b. Specification of the intended purpose, target groups, indications, contraindications
(indents 2-3 of MDR Annex XIV Section 1a): Appendix A3 of MEDDEV 2.7/1 rev.
4 lists additional information to Annex II of the MDR about device description that
can be relevant for planning clinical evaluations. The manufacturer needs to
ensure that inputs for the clinical evaluation plan are in line with the device’s “label,
instructions for use, promotional or sales materials or statements”31 and with the
device’s updated risk management documents.
c. Detailed description of intended clinical benefits with relevant and specified clinical
outcome parameters (indent 4 of MDR Annex XIV Section 1a): MEDDEV 2.7/1 rev.
4 Appendix A7.2 Section b provides relevant additional information with respect to
the definition of clinical benefits. MEDDEV 2.7/1 rev. 4 Appendix A7.2 Section c
provides relevant information with respect to the quantification of benefits and
determination of relevant outcome parameters, which may be useful for clinical
evaluation planning.
d. Specification of qualitative and quantitative aspects of clinical safety and
performance (indents 5-7 of MDR Annex XIV Section 1a): The level of clinical
evidence required for the device under evaluation needs to be determined by the
manufacturer and verified by the notified body. The level of clinical evidence shall
30 MDR, Annex XIV, Part A, section 1.
31 MDR, Article 2 (12).
Page 11 of 22
be appropriate in view of the characteristics of the device and its intended
purpose.32
The proposed level of clinical evidence should take into account the specification
of methods to be used for examination of qualitative and quantitative aspects of
clinical performance and clinical safety with clear reference to the determination of
residual risks and side-effects. MEDDEV 2.7/1 rev. 4 appendix A6 describes
examples of studies that lack scientific validity for the demonstration of adequate
clinical performance and/or clinical safety. MEDDEV 2.7/1 rev. 4 section 9.3.2 also
provides relevant guidance. It also has to take into account the intended clinical
benefits to patients with relevant and specified clinical outcome parameters as well
as an indicative list and specification of parameters to be used to determine, based
on the state of the art in medicine, the acceptability of the benefit-risk ratio for the
various indications and for the intended purpose or purposes of the device.33
For medical devices which have been subject to conformity assessment according
to Directives, it should be possible to provide a clear justification for the level of
clinical evidence required to reach a demonstration of conformity based on clinical
data providing sufficient clinical evidence at the end of the data analysis stage.
Manufacturers should identify benefits and risks of the device under evaluation,
take into account available alternative treatment options and a clinical assessment
of residual risks associated with the device before justifying the level of clinical
evidence. As an outcome of this step, it should be possible to conclude if the device
is one which has a clearly positive benefit–risk determination, when alternatives
are considered, or a marginal one. Special attention is required, with respect to
devices with a marginal benefit-risk, at both the stage of initial conformity
assessment and when designing the post-market surveillance or clinical follow-up
of the device.
According to the MDR, parameters to be used to “ determine…. the acceptability of
the benefit-risk ratio for the various indications and for the intended purpose or
purposes of the device” need to be based on the state of the art in medicine.34
Section 8.2. of MEDDEV 2.7/1 rev. 4 indicates how data on the current state of the
art in medicine can be identified.
6.2. Annex XIV Part A Section 1b: Identify available clinical data35
It is important to identify all available sources of clinical data from both the pre-market
and post-market phases. This will include all of the clinical data which is generated and
held by the manufacturer as well as clinical data for equivalent or similar devices36.
Clinical data is defined in the MDR and the sources of data are specified in Article 2(48).
Sections 6.2.1 and 6.2.3 below provide additional guidance with respect to the use of
these data sources for legacy devices.
It should be noted that, apart from devices for which Article 61(10) may be applied, the
MDR requires confirmation of conformity with the relevant GSPRs to be based on clinical
data as defined in Article 2(48). However, other types of data may provide supportive or
clarifying information: this may include data derived through evaluation of state of the art,
32 MDR, Article 61(1).
33 MDR, Annex XIV, Part A, section 1 (a) 5th indent.
34 MDR, Annex XIV, Part A, section 1.
35 Guidance with respect to identification of clinical data is provided in section 8 and Appendix A4 and A5 of MEDDEV 2.7/1 rev. 4.
36 Section 5, MDCG 2020-05 Clinical Evaluation – Equivalence, A guide for manufacturers and notified bodies.
Page 12 of 22
evaluation of clinical data for similar devices (as described in Section 1.2 of this
document), usability or simulated use testing, etc. A summary of considerations related
to use of clinical and non-clinical data sources is provided in Appendix III of this document.
6.2.1. Pre-market sources of clinical data
For the purpose of legacy devices, pre-market sources of clinical data may include:
Clinical investigation reports of the device concerned;
Clinical investigation reports or other studies reported in scientific literature, of a
device for which equivalence to the device in question can be demonstrated in
accordance with the MDR;
Reports published in peer reviewed scientific literature on other clinical experience of
either the device in question or a device for which equivalence to the device in
question can be demonstrated;
Other pre-market data, e.g. case reports on experience with the use of the device in
question, such as compassionate or humanitarian exceptional use reports. Note that
this kind of pre-market data may be more prone to bias, compared to those listed
above.
It should be noted that MDR Article 2(48) provides a narrower definition of what
constitutes clinical data sources as compared to the Directives which allow unpublished
reports on other clinical experience to contribute to the clinical evaluation. Such data
sources may provide informative context for the clinical evaluation of legacy devices.
6.2.2. Post-market sources of clinical data
Post-market sources of clinical data refer to data collected following the initial CE marking
under the Directives (or prior to introduction of a new indication or design variant). This
may include:
PMS clinical data, complaint and incident reports;
PMCF studies, including post-market clinical investigations;
Independent clinical studies conducted using the device37;
Device registries;
Data retrieved from the literature.
For well-established technologies the clinical evaluation can be based on data coming
from similar devices, under the conditions detailed in paragraph 6.5 (e). With respect to
legacy devices, when clinical data from equivalent devices is used, equivalence must be
demonstrated according to the requirements of the MDR.38,39
6.3. Annex XIV Part A Section 1c: Appraisal of the clinical data
The clinical data sets should be subject to an appraisal with respect to their relative
contribution to the overall clinical evaluation. It is important to perform analysis of the
methodological quality of data obtained from different sources to identify and assess the
level of evidence, bias, other inherent weakness or other possible shortcomings.
Clinical investigations, other sources of clinical data and post-market sources of clinical
data can be of variable methodological quality and therefore an appraisal of the design of
37 Including for example devices used during clinical trials of pharmaceutical substances, or accessories to other medical devices,
where the device is clearly identified.
38 MDR, Annex XIV and Article 2(48).
39 MDCG 2020-5 Clinical Evaluation – Equivalence, A guide for manufacturers and notified bodies.
Page 13 of 22
these studies is important. Examples of studies that lack scientific validity for
demonstration of adequate clinical performance and / or clinical safety can be found in
Appendix A6 General principles of clinical evaluation of MEDDEV 2.7/1 rev. 4. The use
of vigilance data, in general is appropriate for identification of any new risks, events in
subpopulations, examining trends in PMS reports etc. With respect to the utilisation of
post-market surveillance data for the purpose of conformity assessment, it is important to
recognise that uncontrolled sources of clinical data – for example complaint or incident
report data – cannot always provide reliable data with respect to the incidence of risks
and cannot provide an estimate of uncertainty i.e. a confidence interval. Due to limitations
of complaints reporting, the use of estimates such as [number of incidents or complaints]
/ [number of device sales] cannot generally be considered sufficient to provide proof of
safety; their use should be limited to cases where data from pre-market or post-market
clinical investigations or PMCF studies are not deemed appropriate.
Additional information on the use of information derived from vigilance data, device
registry data, case series, patient dossiers and other use data can be found in section
9.3.1 (c) of MEDDEV 2.7/1 rev. 4.
Clinical data appraisal should be conducted using verified/validated assessment tools.
Examples include methodological quality assessment tools developed by medical
researchers and scientists to assess published clinical data such as Appendix F of IMDRF
MDCE WG/N56 on Clinical Evaluation, Cochrane Collaboration’s tool for Randomized
Controlled Trials (RTC), MINORS (Methodological index for non-randomized studies),
Reisch tool (for non-randomized interventional studies), Newcastle-Ottawa Scale (NOS)
for assessing the quality of nonrandomised studies in meta-analyses. Their detailed
description, the inclusive list of major components of each tool is included in the paper by
Zeng X, Zhang Y, Kwong JS et al. “The methodological quality assessment tools for
preclinical and clinical studies, systematic review and meta-analysis, and clinical practice
guideline: a systematic review”40. This list is not exhaustive. Additional validated tools
may become available in the future.
6.4. Annex XIV Part A Section 1d: Generation of new clinical data
Legacy devices following the MEDDEV 2.12/2 guidance for PMCF should normally have
collected data on the devices themselves in the post-market phase. In the event that the
postmarket data on the device itself (including PMCF) is not adequately comprehensive
to provide sufficient clinical evidence, and the demonstration of equivalence is no longer
possible under the definition of equivalence in the MDR, new data may need to be
generated prior to CE-marking under the MDR.
In general, there shall be sufficient clinical evidence to confirm safety, performance and
the acceptability of the benefit-risk determination in relation to the state of the art for the
legacy devices prior to CE-marking under the MDR, and such demonstration should not
rely on new PMCF studies started under the MDR to bridge gaps (e.g. indications not
supported by clinical evidence). Where other evidence, for example results of pre-clinical
testing etc. as described in MDR Article 61(10), is used for confirmation of safety and
performance, PMCF studies may be undertaken to confirm these conclusions.
40 J Evid Based Med. 2015 Feb;8(1):2-10. doi: 10.1111/jebm.12141. Review. https://www.ncbi.nlm.nih.gov/pubmed/25594108
Page 14 of 22
6.5. Annex XIV Part A Section 1e: Analysis of the clinical data
The aim of this stage is the determination if all clinical data collected and appraised, as
described in previous stages, demonstrate together conformity with relevant GSPR. In
order to determine the benefit-risk ratio, it is necessary to identify the benefits and risks
associated with the device and the alternatives (if any). Practical guidance is available in
section 10 of MEDDEV 2.7/1 rev. 4.41
Demonstration of compliance with the GSPR, relevant for the device in question have to
be based on:
The usage of reliable, justified and sound analytical methods (where applicable
qualitative, quantitative, or both);
Results of performed comprehensive analysis;
Identification of any missing data and/or gaps;
Determination of PMCF needs.
a. Clinical benefits
Clinical benefit means “the positive impact of a device on the health of an individual,
expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s),
including outcome(s) related to diagnosis, or a positive impact on patient management or
public health”.42 The type of clinical benefit associated with a device depends upon the
device under evaluation and its intended purpose. Examples of clinical benefits and their
quantification can be found in Appendix A7.2 letters (b) and (c) of MEDDEV 2.7/1 rev. 4.
It should be noted that while direct clinical benefits should be supported by clinical data,
indirect clinical benefits may be demonstrable by other evidence such as:
pre-clinical and bench test data (eg compliance to product standards or common
specifications);
real world data such as registries, information deriving from insurance database
records, etc;
data from another device that is used with the subject device which does have
direct clinical data (eg, data from a stent used to justify safety and performance of
a guidewire).
A determination of the level of clinical evidence required to demonstrate an indirect clinical
benefit should be made on the basis of a thorough risk assessment and evaluation of
short, medium and long term clinical risks (for example, a guidewire, although used
transiently, may have long term clinical risks if it leads to vessel dissection).
b. Risks
Risk means the combination of the probability of occurrence of harm and the severity of
that harm.43 The MDR requires manufacturers to establish, document, implement and
maintain a system for risk management.44 The standard ISO 1497145 provides such a
process for managing risks associated with medical devices, as part of an ongoing,
41 This chapter includes references to the MDD, MDR requirements should be used instead, ie. reference to ‘Essential requirements’
should be replaced by GSPR and reference to PMCF should be replaced by the relevant MDR requirements, i.e. in Annex XIV, part B.
42 MDR, Article 2(53).
43 MDR, Article 2(23).
44 MDR, Article 10(2).
45 Medical devices — Application of risk management to medical devices.
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lifecycle approach. The Annex I of the MDR require that manufacturers reduce risks as
far as possible, and to do this, manufacturers must estimate and evaluate the risks
associated with, and occurring during, the intended use and during reasonably
foreseeable misuse.46
The determination as to which risks require the generation of clinical data to support either
the probability and severity of a particular harm, or the effectiveness of a risk control
measure, is one which must be reached upon a case by case basis,47 and the decision
as to when it is necessary to generate further clinical data is not addressed by ISO 14971
and should be an output of the process of clinical evaluation.
Considerations on aspects of risk evaluation, and considerations on the number of
patients needed to obtain sufficient data can be found in Appendix A7 of MEDDEV 2.7/1
rev. 4.
c. Benefit-risk determination, state of the art, alternative treatment options
The MDR requires that any risks which may be associated with the use of the device are
“compatible with a high level of protection of health and safety, taking into account the
generally acknowledged state of the art”48 and that the determination of the acceptability
of the benefit-risk ratio is “ based on the state of the art in medicine ”.49
It is important to remember that a medical device may be used for an indication for which
there are many alternative medical options. This may include the use of medicinal
products, other medical devices, other medical or allied health professional interventions,
a combination of any of these or no intervention. As such, in order to determine a benefit-
risk ratio, up-to-date alternatives must be considered for legacy devices. The
appropriateness and relevance of an alternative treatment option depends upon a wide
range of factors, including the nature of the healthcare system and patient preferences.
To help to describe alternatives, it is necessary to describe the ‘state of the art’ for the
treatment of the indicated clinical condition taking alternative treatments into account. The
state of the art in this context can be taken to mean the generally accepted most effective
treatment option, for the intended purpose relevant to the device under consideration.
Occasionally, this may be subject to differences of opinion between clinical evaluators as
to what is the state of the art, and where such differences exist, these should be described
and taken into account insofar as is possible. In such cases, a thorough evaluation of the
results from published clinical studies of high methodological quality shall be taken into
account. Moreover, where applicable, particular attention shall be paid to therapy
guidelines grounded on principles of evidence based medicine. Novel and innovative
device technology may be subject to a rapidly evolving state of the art for a particular
indication, and where this exists, it should also be noted.
Aspects that influence the acceptability of benefits and risks can be found in Appendix
A7.2 letter (e) and in Appendix A7.4 of MEDDEV 2.7/1 rev. 4.
46 MDR, Annex I, Chapter 1, section 3(c).
47 ISO14971:2007, page v, notes that an individual’s perception of risk can depend upon a range of factors including their cultural
background, the socio-economic and educational background of the society concerned, the actual and perceived state of health of
the patient, and many other factors.
48 MDR, Annex I, Chapter 1, Section 1.
49 MDR, Annex XIV, Part A, Section 1(a).
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d. The level of clinical evidence available to demonstrate conformity based on clinical
data providing sufficient clinical evidence
The MDR requires that the level of clinical evidence is justified and specified by the
manufacturer. The required level of clinical evidence has to be identified, specified and
justified by the manufacturer during the clinical evaluation process. This level has to be
appropriate to demonstrate conformity with the relevant GSPR.
To reach a determination of sufficiency, when considering the available level of clinical
evidence, the manufacturer may use widely available and validated tools when examining
clinical data. These tools are methodological quality assessment tools developed by
medical researchers and scientists to assess published clinical data.50 Examples of these
tools include the Cochrane Collaboration´s tool for RCT or NOS checklist for analytical
studies (see Footnote 40). See MEDDEV 2.7.1 rev 4, Section 9.3.2 ‘How to determine
the relevance of a data set for the clinical evaluation’, for further information.
e. Lack of clinical data providing sufficient clinical evidence
Manufacturers should conduct a gap analysis with respect to the MDR requirements. If
data gaps have been identified, there are different possibilities to bridge those gaps.
While controlled clinical investigations might be the preferred method for collecting clinical
data as part of the PMCF studies for some products, there are other possibilities to gather
relevant clinical data in the field in order to close the clinical data gap. Other alternatives
include, but are not limited to systematic reviews of clinical data published in the literature,
evaluation of results from PMCF studies such as clinically relevant scientifically sound
questionnaires51 or registries. Scientifically sound studies will normally include (note, this
is not a complete list):
Clearly stated research question(s), objective(s) and related endpoints;
An evaluation of potential sources of bias or study distortion, and the impact of
these factors on the potential validity of results;
Design with an appropriate rationale and statistical analysis plan;
A plan for an analysis of the data and for drawing appropriate conclusion(s).
If there is not sufficient supportive clinical evidence with regard to the declared intended
purpose52 including the indications and claims as appropriate, manufacturers shall narrow
the intended purpose of the device under evaluation until it is supported by the available
clinical evidence.
As noted in Section 4, some legacy devices may have limited clinical data, particularly if
they were marketed prior to the publication of the Directives. In some cases, it may be
necessary for the manufacturer to undertake PMCF to generate new data for these legacy
devices prior to CE marking under the MDR, whereas in other cases, particularly for low
risk standard of care devices where there is little evolution in the state of the art, it may
be possible to demonstrate conformity with the relevant GSPRs with a more limited
clinical data set.
Devices previously certified under the Directives might not be considered to have
sufficient clinical data for certification under the MDR. Reasons may include:
50 The suggested tools may also be relevant for unpublished data.
51 Clinically relevant and where possible validated.
52 MDR, Article 2(12).
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changes in the state of the art
data arising from PMS may identify new risks or provide additional clarity with
respect to indications and contraindications
devices previously certified under Quality System annexes of the Directive may
not have been sampled prior to an application for MDR certification, and the
clinical evidence therefore not subject to Notified Body scrutiny
the MDR introduces new requirements on the use of equivalence, which may
reduce the overall volume of data available for demonstration of conformity with
the relevant GSPRs
the MDR has a more explicit definition of what constitutes clinical data, which may
remove some data sources previously used
Although the Directives indicate that data shall be collected in the post-market phase for
all devices53, in practise the data collected may not meet MDR criteria, if the devices were
considered standard of care and were not associated with safety concerns. Stable, well-
established technologies that perform as intended and are not associated with safety
concerns, and where there has been no innovation, are less likely to be the subject of
research, and therefore literature data may be limited or non-existent. In some cases, it
may be necessary for the manufacturer to undertake PMCF to generate new clinical data
for these devices prior to certification under the MDR, even if they are well-established
and have been on the market for several decades, to enable an evaluation of their safety
and clinical performance in relation to an evolving state of the art.
In exceptional cases, particularly for low risk standard of care devices where there is little
evolution in the state of the art, and the device is identified as belonging to the group of
‘well-established technologies’ (see section 1.2 and Appendix III in this document) a lower
level of clinical evidence may be justified to be sufficient for the confirmation of conformity
with relevant GSPRs. This may be supported by clinical data from the PMS provided that
there has been a quality management system in place to systematically collect and
analyse any complaints and incident reports, and that the collected data support the
safety and performance of the device.
53 MDD, Annex II(3.1) indent 7, Annex IV(3), Annex V(3.1) indent 8, Annex VI(3.1) indent 8, Annex VII(4).
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Appendix I - Sections of MEDDEV 2.7/1 rev. 4 which are still relevant under the MDR
for the application of this guidance
The identified sections of MEDDEV 2.7/1 rev. 4 are considered relevant to MDR as they
contain helpful information regarding how to perform activities associated with clinical
evaluation:
6.4. Who should perform the clinical evaluation?
8. Identification of pertinent data (Stage 1)
9. Appraisal of pertinent data (Stage 2)
10. Analysis of the clinical data (Stage 3). This chapter includes references to the
MDD, MDR requirements should be used instead
A3. Device description - typical contents
A4. Sources of literature
A5. Literature search and literature review protocol, key elements
A6. Appraisal of clinical data - examples of studies that lack scientific validity for
demonstration of adequate clinical performance and/or clinical safety
A7.2. Conformity assessment with requirement on acceptable benefit/risk profile
A7.3. Conformity assessment with requirement on performance
A7.4. Conformity assessment with requirements on acceptability of undesirable
side-effects
A10. Proposed checklist for the release of the clinical evaluation report.
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Appendix II – Clinical Evaluation Plan for Legacy Devices54
A modified Clinical Evaluation Plan for legacy devices should include at least:55
An identification of the GSPR that require support from relevant clinical data.
A specification of the intended purpose of the device.56
A clear specification of intended target groups with clear indications and contra-
indications.
A detailed description of intended clinical benefits to patients with relevant and
specified clinical outcome parameters.
A strategy to identify, analyse and assess alternative treatments57.
A specification of methods to be used for examination of qualitative and
quantitative aspects of clinical safety with clear reference to the determination of
residual risks and side-effects;
An indicative list and specification of parameters to be used to determine, based
on the state of the art in medicine, the acceptability of the benefit-risk ratio for the
various indications and for the intended purpose or purposes of the device.
An indication how benefit-risk issues relating to specific components such as use
of pharmaceutical, non- viable animal or human tissues, are to be addressed.
A strategy and methodology to identify, analyse and appraise all relevant available
clinical data in light of the changed definition for clinical data.
Evidence for equivalence, if clinical data from an equivalent device is included in
the clinical evaluation.
A definition of the required level of clinical evidence, which shall be appropriate in
view of the characteristics of the device and its intended purpose.58 59 60
A strategy and methodology to systematically collect, summarise and assess post
market surveillance data to demonstrate continuing safety and performance, and
to what extent complaints with regards to safety and performance have been
observed with the legacy devices.61
54 MDR, Annex VII, 4.11.
55 Appendix A3 of MEDDEV 2.7/1 rev. 4 lists information that can be relevant for planning clinical evaluations. The manufacturer needs
to make sure that input for the clinical evaluation plan are in line with the device’s “label, instructions for use, promotional or sales
materials or statements” and with the device’s updated risk management documents.
56 In order to fully identify the intended purpose(s) of a legacy device, the manufacturer needs to consider the data that is foreseen on
the label, in the instructions for use or in promotional or sales materials or statements that are foreseen for the device. Typical elements
of the intended purpose can be found in Appendix A3 of MEDDEV 2.7/1 rev. 4.
57 MDR, Article 61(3)(c).
58 MDR, Article 61(1).
59 The proposed level of clinical evidence should take into account the specification of methods to be used for examination of qualitative
and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects.
60 To determine the level of clinical evidence it is necessary to identify benefits and risks of the device under evaluation and to take
into account available alternative treatment options, and a clinical assessment of failure modes associated with the device.
61 MDR Article 83 and MDR Annex III.
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Appendix III – Suggested hierarchy of clinical evidence for confirmation of
conformity with relevant GSPRs under the MDR
Sources of pre- and post- market clinical data are described in Sections 6.2.1 and 6.2.2
of this document. Reference is also made to clinical evidence which may provide
contextual, supportive or clarifying information for demonstration of conformity with the
relevant GSPRs. A suggested hierarchy of evidence and considerations to apply is
provided in the table below, ranked roughly in order from strongest to weakest (some
variations may apply dependent on the device, GSPR for which evidence is required, and
quality of individual data sources):
Rank Types of clinical data and
evidence Considerations / comments
1 Results of high quality62
clinical investigations
covering all device variants,
indications, patient
populations, duration of
treatment effect, etc This may not feasible or necessary for certain
well-established devices with broad indications
(eg Class IIb legacy sutures, which could be
used in every conceivable patient population)
2 Results of high quality
clinical investigations with
some gaps Gaps must be justified / addressed with other
evidence in line with an appropriate risk
assessment, and clinical safety, performance,
benefit and device claims.
Assuming the gaps can be justified, there should
be an appropriate PMCF plan to address
residual risks.
Otherwise, manufacturers shall narrow the
intended purpose of the device until sufficient
clinical data has also been generated.
3 Outcomes from high quality
clinical data collection
systems such as registries63 Is there sufficient evidence of the quality of the
data collected by the registry64, 65?
Are the devices adequately represented?
Are the data appropriately stratified?
Are the endpoints appropriate to the safety,
performances and endpoints identified in the
clinical evaluation plan?
4 Outcomes from studies with
potential methodological
flaws but where data can still
be quantified and
acceptability justified66 Many literature sources fall into this category,
due to limitations such as missing information,
publication bias, time lag bias, etc. This applies
equally to publications in the peer-reviewed
scientific literature. However, for legacy devices
62 Refer to data appraisal considerations described in Section 6.3 of this guidance.
63 Please note that the Considerations / Comments listed in point 2 also apply to these studies.
64 http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-methodological-principles.pdf
65 http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-160930-principles-system-registries.pdf
66 Please note that the Considerations / Comments listed in point 2 also apply to these studies.
Page 21 of 22
where no safety or performance concerns have
been identified, these sources can be sufficient
for confirmation of conformity to the relevant
GSPRs if appropriately appraised and the gaps
are identified and handled.
High quality surveys may also fall into this
category.
Class III legacy devices and implantable legacy devices which are not well-established
technologies should have sufficient clinical data as a minimum at level 4. Those devices
which are well-established technologies may be able to confirm conformity with the
relevant GSPRs via an evaluation of cumulative evidence from additional sources as
listed below. Reliance solely on complaints and vigilance is not sufficient.
5 Equivalence data (reliable /
quantifiable) Equivalence must meet MDR criteria.
It is normally expected that manufacturers
should gather data on their own devices in the
post-market phase, therefore reliance on
equivalence should be duly justified, and linked
to appropriate PMCF or proactive PMS.
6 Evaluation of state of the art,
including evaluation of
clinical data from similar
devices as defined in
Section 1.2 of this document This is not considered clinical data under the
MDR, but for well-established technologies only
can be considered supportive of confirmation of
conformity to the relevant GSPRs.
Data from similar devices may be also important
to establish whether the device under evaluation
and similar devices belong to the group of
devices considered as “well established
technologies” (WET). See section 1.2 in this
document for the criteria for WET. Data from
similar devices may be used, for example, to
demonstrate ubiquity of design, lack of novelty,
known safety and performance profile of a
generic group of devices, etc.
7 Complaints and vigilance
data; curated data This falls within the definition of clinical data
under MDR Article 2(48), but is not generally
considered a high quality source of data due to
limitations in reporting. It may be useful for
identifying safety trends or performance issues.
High volume data collected within a robust
quality system may provide supportive evidence
of device safety.
8 Proactive PMS data, such
as that derived from surveys This falls within the definition of clinical data
under MDR Article 2(48), but is not generally
considered a high quality source of data due
limitations associated with sources of bias and
quality of data collection. It may be useful for
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identifying safety concerns or performance
issues.
9 Individual case reports on
the subject device This falls within the definition of clinical data
under MDR Article 2(48), but is not considered a
high quality source of data due to limitations in
generalising findings to a wider patient
population, reporting bias, etc. It may provide
supportive or illustrative information with respect
to specific claims.
10 Compliance to non-clinical
elements of common
specifications considered
relevant to device safety and
performance Common specifications which address clinical
investigation or data requirements directly would
rank higher in this hierarchy. Common
specifications may address clinically relevant
endpoints through non-clinical evidence such as
mechanical testing for strength and endurance,
biological safety, usability, etc.
11 Simulated use / animal /
cadaveric testing involving
healthcare professionals or
other end users67 This is not clinical data, but may be considered
evidence of confirmation of conformity to
relevant GSPRs, particularly in terms of
usability, such as for accessories or instruments.
12 Pre-clinical and bench
testing / compliance to
standards62 Pre-clinical and bench testing may address
clinically relevant endpoints through non-clinical
evidence such as mechanical testing for
strength and endurance, biological safety,
usability, etc.
67 This may be of interest in the case of application of Article 61(10). |
mdcg_clinical_evaluationtemplate_en.pdf.txt | Medical Devices
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MDCG 2020-13
Clinical evaluation assessment report template
July 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG) established
by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and a representative of the European Commission chairs it. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
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Contents
Introduction ............................................................................................................................... ....... 3
Scope ......................................................................................................................... ..................... 3
Approach to Template .......................................................................................................... ........... 4
Template CEAR ................................................................................................................. ............. 6
Section A: Administrative particulars (notified body, manufacturer, product and clinical
evaluation report reference) .................................................................................................. ....... 6
Section B: Reviewers involved in the notified body assessment of the clinical evaluation ........... 7
Section C: Device description, classification, clinical evaluation plan, information materials
supplied by the manufacturer, common specifications and harmonised standards applied, equivalence and state of the art .............................................................................................. ..... 8
Section D: Clinical literature review.......................................................................................... .. 15
Section E: Clinical investigations and related documentation .................................................... 18
Section F: PMS, PMCF and the plan for updates ...................................................................... 20
Section G: IFU, SSCP, labelling and other information supplied with the device ....................... 21
Overall Conc lusions: .......................................................................................................... ........ 24
Specific Considerations ....................................................................................................... .......... 25
Section I: Clinical evaluation c onsultation procedure for certain class III and class IIb devices
(Article 54) .................................................................................................................. ............... 25
Section J: Where demonstration of conformity based on clinical data is not deemed appropriate
(Article 61(10)) .............................................................................................................. ............. 28
Section K: The voluntary clinical consultation on the clinical development strategy (Article 61(2))
.............................................................................................................................. ..................... 30
Medical Devices
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List of acronyms
CEAR Clinical Evaluation Assessment Report
CECP Clinical Evaluation Consultation Procedure CER Clinical Evaluation Report CIP Clinical Investigation Plan EUDAMED European Databank on Medical Devices IFU Instructions for Use MDR Medical Device Regulation (Regulation (EU) 2017/745 on me dical devices)
PMCF Post-Market Clinical Follow-up PMS Post-Market Surveillance PSUR Post-Market Surveillance Update Report
SRN Single Registration Number
SSCP Summary of Safety and Clinical Performance TDAR Technical Documentation Assessment Report UDI-DI Unique Device Identification Device Identifier
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Introduction
A c l i n i c a l e v a l u a t i o n a s s e s s m e n t r e p o r t ( C E A R ) i s a r e p o r t u s e d b y t h e n o t i f i e d b o d y t o c l e a r l y d o c u m e n t t h e
conclusions of its assessment of the clinical evidence presente d by the manufacturer in the clinical evaluation report
(CER) and the related clinical evaluation that was conducted – a core requirement of the Medical Device Regulation
(EU) 2017/745 (MDR). The clinical evaluation must be a part of the manufacturer's qu ality management. It should also be aligned with and
reflected in other aspects of the technical documentation, such as:
• The interface of the clinical eva luation with the risk manageme nt process and its appraisal and analysis of the pre-
clinical and clinical evaluation and their relevance for the de m o n s t r a t i o n o f c o n f o r m i t y w i t h t h e r e l e v a n t
requirements in Annex I.
1
• Post-market surveillance including any corrective and preventiv e actions involving the device.
• Post-market clinical follow-up pl an and where appropriate the p ost-market clinical follow-up report.
• Instructions for use, which provide adequate information on int ended purpose, proper use and warnings about
risks to patients and healthcare practitioners.
As part of its conformity assessment activities the notified bo dy shall examine, validate and verify that manufacturers'
procedures and documentation adequately address the requirement s relating to the technical documentation
2 and
clearly document its assessment3.
The notified body shall review the clinical evidence presented by the manufacturer in the clinical evaluation report
and the related clinical evaluation that was conducted, which i ncludes4:
Assessing the suitability of using data from claimed equivalent devices, taking into account factors such as new
indications and innovation. The notified body shall clearly doc ument its conclusions on the claimed equivalence,
and on the relevance and adequacy of the data for demonstrating conformity. For any characteristic of the device
claimed as innovative by the manufacturer or for new indication s, the notified body shall assess to what extent
specific claims are supported by specific pre-clinical and clin ical data and risk analysis.
Verifying that the clinical evidence and the clinical evaluatio n are adequate and shall verify the conclusions drawn
by the manufacturer on the conformity with the relevant general safety and performance requirements. That
verification shall include consideration of the adequacy of the benefit-risk determination, the risk management,
the instructions for use, the user training and the manufacture r's post-market surveillance plan, and include a
review of the need for, and the adequacy of, the PMCF plan prop osed, where applicable.
Considering the clinical evaluation and the benefit-risk determ ination, and whether specific milestones need to be
defined to allow the notified body to review updates to the cli nical evidence that result from post-market
surveillance and PMCF data.
The outcome of this assessment must be clearly documented in th e CEAR.
5 A harmonised CEAR template provides a
standardised method for documenting the notified body’s assessm ent of the manufacturer’s clinical evaluation and
related documents. CEARs in this format will also support specific additional requirements such as the clinical
evaluation consultation procedure6 and reviews by designating authorities.7
Scope
This template applies to MDR Annexes IX section 4 and Annex X s ection 3. It also applies to assessments of technical
documentations on a sampling basis for class IIa/IIb devices in accordance with Annex IX sections 2.3 and 3.5 and
1 MDR, Annex VII Section 4.5.1 and 4.5.5
2 MDR, Annexes II and III
3 MDR Annex VII Section 4.5.5 and 4.6
4 MDR, Annex IX Sections 4.4 to 4.7
5 MDR, Annex IX 4.8
6 MDR, Article 54
7 MDR, Article 45 Medical Devices
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Section 10 of Annex XI(A).8 Aspects related to the clinical evaluation assessment are also laid down in Section 4.5.5
an d oth er r ele van t s ecti on s of A n n e x V II. It als o ap p lies to m ed ical d e vice s fo r wh ich clin ical d at a is n o t d ee med
appropriate,9 to demonstrate conformity with Annex I, and the demonstration of an adequate justification for this.10
Approach to Template
Please note that the explanatory text under each heading provid es brief descriptions of the type of information which
will be included by the notified body, however it is not an all -inclusive list and further detail may be required depending
upon the device or the intended purpose for which it will be us ed. This template represents the minimum content for
a CEAR and needs to be incorporated into the process and proced ures of the notified body.11 The CEAR shall also make
a recommendation to support a final review and a final decision to be taken by the notified body.
Any non-compliances identified during the assessment of the asp ects described in the relevant sections of the
template, as well as the appropriate follow up actions taken by the manufacturer to close them need to be
documented. This template may be used by the notified body to d ocument the non-compliance/deficiencies and
queries raised during the assessment and the assessment of resp onses received. It is important to note that the
completed CEAR may not necessarily contain comprehensive inform ation regarding the non-compliance/deficiencies,
which were raised by the notifie d body during the course of the assessment. The CEAR shall document the outcome12
and the conclusions13 of the assessment.
Designating authorities shall assess whether the clinical evalu ation assessment was conducted appropriately,
considering the assessment, procedures, associated documentatio n and the conclusions;
14 Designating authorities will
have access to the complete ‘audit trail’ of the notified body.
Expert panels who are conducting a clinical evaluation consulta tion procedure shall assess the CEAR, however they
may not have access to the complete conformity assessment for t he device and associated procedures and
documentation. To enable the expert panel work, the CEAR shall provide sufficient information with respect to the
clinical evidence provided by the manufacturer, in particular c oncerning the benefit-risk determination, the
consistency of that evidence with the intended purpose, includi ng the medical indication or indications and the PMCF
plan.15 Expert panels may also request the notified body to present it s conclusions regarding the clinical evaluation
assessment report.16
It is only once all the non-compliances have been closed out th at the relevant tick-box should be completed to signal
t h a t t h e a s s e s s m e n t i s p o s i t i v e . I n t h e r a r e e v e n t t h a t t h e r e i s one or more open minor non-compliances at the
conclusion of the assessment stage, this must be clearly descri bed in the template, together with appropriate follow-
u p a c t i o n s t o c l o s e t h e m , a n d e x p e c t e d c o m p l e t i o n t i m e l i n e s t o be followed by the manufacturer under the
supervision of the notified body.
The sections covered in Annex I of this template are generally applicable depending on the type of assessment. The
sections covered in Annex II may be applicable, depending upon the device under evaluation. All applicable sections
should be completed, relevant conclusions reached and correspon ding boxes ticked for the report to be complete .
The CEAR should be signed-off by the relevant personnel in acco rdance with the quality management system of the
notified body. When making available the CEAR to third parties, the notified body should treat the personal data within
8 MDCG 2019-13
9 Article 61(10)
10 Based on the results of the manufacturer's risk management and on consideration of the specifics of the interaction between
the device and the human body, the clinical performance intende d and the claims of the manufacturer.
11 MDR, Annex VII Section 4.6
12 MDR, Annex IX Section 4.8
13 MDR, Annex VII Section 4.6
14 MDR, Article 45(3)
15 MDR, Annex IX Section 5.1(c)
16 MDR, Annex IX Section 5.1(b) Medical Devices
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it as per its procedures for the management of personal data, i n compliance with Regulation (EU) 2016/679 General
Data Protection Regulation.
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Template CEAR
Section A: Administrative particulars (notified body, manufactu rer, product and clinical evaluation report reference)
Medical device name model and type:
☐ Basic UDI-DI(s) (if available):
☐ Certificate number (if applicable):
Project number: Risk Class:
Applicable code(s) per Commission Implementing
Regulation (EU) 2017/2185:
Manufacturer(s) name and SRN:
Authorised representative (if applicable)
name and SRN:
Notified body:
Notified body number:
E-mail contact of NB:
Telephone contact of NB:
Parts of this template which have been
applied
General considerations
17
☐ Section A: Administrative particulars
☐ Section B: Reviewers involved
☐ Section C: Device description,
classification, clinical evaluation plan,
information materials supplied by the
manufacturer, common specifications and harmonised standards applied, equivalence and state of the art
☐ Section D: Clinical literature review
☐ Section E: Clinical investigations and
related documentation
☐ Section F: PMS and PMCF
☐ Section G: IFU, SSCP, labelling and other
information supplied with the device
☐ Section H: Summary of all available data
and conclusions
☐ Overall Conclusions
Specific Considerations Type of assessment:
☐ Initial conformity assessment
☐ Assessment of changes18 and update of the clinical
evaluation19
☐ Re-certification assessment
☐ Assessment of technical documentation for class IIa
/ IIb devices on a sampling basis
Intended purpose:
Check of clinical evaluation report authors
☐ CER dated and signed
☐ CVs provided for CER author(s)
Comments:
Confirm CVs are up to date
Confirm CER authors have full range of
required expertise represented (e.g. research methods, information
17 These must be completed in all cases
18 MDR, Annex IX Section 4.10
19 For example in accordance with Annex VII, Section 4(10) Medical Devices
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According to Annex / section:
Insert the Annex and section management, regulatory requirements,
device technology, diagnosis and
management of conditions to be treated)
CVs are considered acceptable: ☐
☐ Section I: Clinical evaluation
consultation procedure for certain class III and class IIb devices (Article 54)
☐ Section J: Where demonstration of
conformity based on clinical data is not deemed appropriate (Article 61(10))
☐ Section K: The voluntary clinical
consultation on the clinical development strategy (Article 61(2))
Technical file identification number and technical documentatio n assessment report (TDAR) reference if available or any other references that allow the correlation between TDAR and
CEAR:
Documents assessed:
For example, clinical evaluation report, clinical investigation plan, clinical investigation re port, ethics committee approval , Competent Authority approval, post market surveillance data,
publications.
Include the title, version number/reference and date of the doc uments.
When the CER has been updated verify that this update correspon ds to the most recently updated PMS/PMCF reports and any condit ions set on the first certification, if applicable.
Note that references to the technical documentation should be m ade in order to ensure document control.
Section B: Reviewers involved in the notified body assessment o f the clinical evaluation
Provide the name or the employee code of the personnel with rel evant clinical expertise (as per 3.2.4 of annex VII):
Relevant clinical expertise:
Have additional reviewers been involved? Medical Devices
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☐Yes
☐No
Provide a justification:
Additional reviewers assigned to review the clinical evaluation
Number of additional reviewers
Names of additional reviewers:
Separate the internal and external clinical
reviewers.
You may use employee codes
Specific aspects assessed (by each additional reviewer): For example, rationale
for the design and chosen statistical methodology of clinical i nvestigation etc. Competence area / codes: List of relevant MDR codes
or area this person is authorised to, according to the
Authorisation Matrix, as of Annex VII, 3.3.2)
Relevant expertise:
Section C: Device description, classification, clinical evaluat ion plan, information materials supplied by the manufacturer, c ommon specifications and harmonised standards applied,
equivalence and state of the art
Device description
Describe the device and comment on the intended purpose, includ ing:
The intended patient population and medical conditions to be di agnosed, treated and/or monitored.
A general description of the key functional elements: its parts /components (including software if appropriate), its formulatio n, its composition, its functionality and, where relevant,
its qualitative and quantitative composition.
The principles of operation of the device and its mode of actio n; explanation of any novel features.
Classification
List the applicable classifica tion rule(s) and indents.
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Device configurations/variants included in this application:
Include the manufacturers description of the sizes, differences in design features, different configurations etc.
Include an image of the device where possible.
If applicable, include the manufacturers description of the dev ice history and/or changes in the device since its last assessm ent.
Where relevant, include the manufacturers description of the re ason for differences in design variants with illu strative image s where possible.
Accessories or compatible devices: Describe any accessories or compatible devices if any or state, “none”).
Include component devices in case of system/procedure pack. If the use of accessories or compatible devices has an impact o n clinical safety or performance or the scope or validity of th e clinical evaluation, identify this here.
If it is necessary to understand the usage of the device, inclu de images or other relevant inf ormation such as diagrams.
Previous generations of the device and similar devices (if appl icable):
Verify that the manufacturer has provided:
an overview of the previous generation or generations of the de vice produced by the manufacturer, where such devices exist.
an overview of identified similar devices available on the Unio n or international markets, where such devices exist, including length of time on the market, sales volume etc.
Non-compliances identified and resolved for this section may be briefly described in this box
Device details, intended purpose and classification are:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Clinical evaluation plan Medical Devices
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Briefly summarise the manufacture r’s clinical evaluation plan a nd confirm that it meets the requirements of Annex XIV Part A S ection 1a, highlighting the areas which require particular
attention for this assessment:
an identification of the general safety and performance require ments that require support from relevant clinical data;
a specification of the intended purpose of the device;
a clear specification of intended target groups with clear indi cations and contra-indications;
a detailed description of intended clinical benefits to patient s with relevant and specified clinical outcome parameters;
a specification of methods to be used for examination of qualit ative and quantitative aspects of clinical safety with clear re ference to the determination of residual risks and side-
effects;
an indicative list and specification of parameters to be used t o determine, based on the state of the art in medicine, the acc eptability of the benefit-risk ratio for the various indication s
and for the intended purpose or purposes of the device;
an indication how benefit-risk issues relating to specific components such a s use of pharmaceutical, non-viable animal or human tissues, ar e to be addressed; and
a clinical development plan indi cating progression from explora tory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmat ory investigations, such as
pivotal clinical investigations, and a PMCF as referred to in P art B of Annex XIV of MDR, with an indication of milestones and a description of potential acceptance criteria.
A detailed description of the clinical development plan is not required for the purpose of this template unless there are spec ific concerns.
Add the manufacturer’s reference and version and date of the cl inical evaluation plan.
Clinical performance
Summarise the clinical data to d emonstrate the ability of the d evice, resulting from any direc t or indirect medical effects wh ich stem from its technical or functional characteristics, incl uding
diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical bene fit for patients, when used as intended by the manufacturer.
Describe the clinical benefits.
Safety
Does the clinical evaluation adequately addresses the qualitati ve and quantitative aspects of clinical safety with clear refer ence to the determination of residual risks and undesirable sid e-
effects and the confirmation of the relevant safety and perform ance requirements provided for in Annex I?
Summarise the clinical data regarding safety, and also describe residual risks and any undesirable side- effects.
Does the clinical evaluation spec ify the methods to be used for examination of qualitative and quantitative aspects of clinica l safety with clear reference to the determination of residual risks
and undesirable side-effects?
If relevant, briefly summarise any significant complaint, trend s or vigilance issues associated w ith earlier device iterations , which may be equivalent or similar devices, and explain wheth er
or not they have any impact on the clinical evaluation assessme nt.
Non-compliances identified and resolved for this section may be briefly described in this box Medical Devices
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The clinical evaluation plan is:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Common specifications, harmonised standards or other solutions applied
Are there common specifications relevant to the device under ev aluation?
Have they been complied with? If not:
20
Explain any deviations and how t hese might affect the validity of the clinical evaluation and its conclusions, and any equival ence claims.
Confirm that the manufacturer has adopted solutions that ensure a level of safety and performanc e that is at least equivalent thereto in accordance with Article 9(3).
Are there harmonised standards relevant to the clinical evaluat ion of the device under evaluation?
Have they been applied? If partially applied add the manufacturers justification and co nfirm that the manufacturer has adopted solutions that ensure a level of safety and performanc e required by the Regulation
(EU) 2017/745.
If there are deviations explai n any deviations and how these mi ght affect the validity of the clinical evaluation and its conc lusions, and any equivalence claims.
Is the most up-to-date revision being used by the manufacturer? (state which revision was used)
Are there other solutions that have been applied?
Describe any standards, guidance or other solutions that have b een applied, and the manufacturers justification
Non-compliances identified and resolved for this section may be briefly described in this box
20 Excluding devices listed in Annex XVI which must comply with th e relevant common specifications in accordance with Article 9(4 ). Medical Devices
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The application of CS, harmonised standards or other solutions is:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
The demonstration of equivalence
Is the clinical evaluation based upon clinical investigation(s) or other studies reported in scientific literature, of a devic e for which equivalence to the device in question can be
demonstrated?
State Yes / No Device(s) to which equivalence has been claimed:
Is the clinical evaluation based upon reports published in peer reviewed scientific literature on a device for which equivalen ce to the device in question can be demonstrated?
State Yes / No
If yes, specify the source(s) of the data, if it is the device in question, or an equivalent device, or both.
Device(s) to which equivalence has been claimed:
Device which is most relevant:
Assessment of equivalence
1. Equivalence rationales:
Indicate which devices are/are not equivalent, and confirm that data relating to devices which are not equivalent have been ex cluded from the analysis of clinical data for the purposes for
demonstrating safety and performance.
If equivalence has been claimed to more than one device, each d emonstration of equivalence can only be based on a single devic e. Each equivalent device must meet all three equivalence
criteria (clinical, technical, biological).
2. Are the devices equivalent in accordance with Section 3 of Anne x XIV including technical, biologi cal and clinical characterist ics?
State Yes / No
Identify any differences in these parameters, and verify why th ese are not expected to adversely affect the safety and perform ance of the medical device under evaluation. Medical Devices
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Non-compliances identified and resolved for this section may be briefly described in this box
The demonstration of equivalence is:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Access to data
Comment on the manufacturer’s access to data, relating to devic es with which they are claiming equivalence in order to justify their claims of equivalence.
For implantable and Class III device s, if equivalence is claime d with a device marketed by another manufacturer, confirm that there is a current valid contract between the two
manufacturers allowing ongoing access to the technical document ation in accordance with Article 61 (5) of the MDR.
Has the original clinical evaluat ion been performed in complian ce with the requirements of Regulation 2017/745, and has the ma nufacturer of the second device provided clear evidence
thereof?
State Yes / No
Confirm that access to data is sufficient to provide the manufa cturer with enough information about the equivalent devices to support equivalence claims, in cluding any testing which may
have been undertaken to confirm equivalence of specifications/p erformance/etc.
Any other limitations with re spect to equivalent devices:
Comment on any other limitations with respect to the equivalent devices or manufacturer’s equivalence claims, and the extent t o which these limitations impact the manufacturer’s clinical
evaluation and conclusions.
Non-compliances identified and resolved for this section may be briefly described in this box
Manufacturer demonstration of equivalence and access to data is :
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ Medical Devices
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Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
State of the art
Benchmark devices, state of the art and other available treatme nt options:
Describe the alternative availabl e treatment options identified by the manufacturer which could offer comparable safety and pe rformance for the same treatment indications / patient
populations, etc.
Briefly describe how benchmarks for safety and performance have been identified by the manufacturer in terms of the state of t he art. Benchmarks will norma lly be based on aggregate data
from several devices considered to have acceptable performance (e.g. systematic reviews or registry analysis); if individual d evices are selected as benchmarks for safety and performance, a
suitable rationale should be provided.
Confirm that the manufacturer's description of the state of the art is based upon an appropriate literature search (see sectio n D)?
For devices previously marketed, is the description of the stat e of the art still accurate? Can the device still be considered to be state of the art?
Safety, performance and benefit-risk claims - requirements in t erms of the state of the art:
What performance and safety endpoints has the manufacturer iden tified?
In light of the outcomes achievable with benchmark products and other treatment options, are these endpoints appropriate and c linically relevant? Have surrogate endpoints been
adequately justified?
Has the manufacturer adequately described an indicative list an d specification of parameters used to determine, based on the s tate of the art in medicine, the acceptability of the benefit-
risk ratio for the various indications and for the intended pur pose or purposes of the device?
Non-compliances identified and resolved for this section may be briefly described in this box
Manufacturer demonstration of state of the art is:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ Medical Devices
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Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Novelty
Include the manufacturer’s explanation of any novel features of the device and/or the related clinical procedures and their pu rpose.
What is the possible clinical or health impact in terms of bene fit/risk?
Is novelty adequately addressed? ☐
Section D: Clinical literature review
With respect to the search criteria of the literature review, does it:
☐ Address all device sizes, variants, model and accessories?
☐ Address the same clinical condition?
Further information regarding literature search methods is avai lable in MEDDEV 2.7/1 revision 4, section A5.
Searches for the device in question, equivalent devices and oth er devices (for example to support a description of the state o f the art) should be described separately.
With respect to the selection criteria of the literature review, does it relate to both below:
☐ The device under evaluation or to a device demonstrated to be equivalent?
☐ The state of the art or alternative available treatment option ?
The clinical evaluation should c learly describe the selection c riteria with respect to the regulatory purpose to which it will apply. The CER should clearly differentiate between the two ty pes
of data referenced above. If the data does not relate to either of the above, provide a rationale with respect to its inclusio n.
Literature search protocol21
Provide a brief summary of the literature search strategy appli ed, commenting on:
21 For general guidance on a literat ure search, see MEDDEV 2.7/1 r evision 4, A5. Literature search and literature review protocol , key elements. Medical Devices
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• The adequacy of search terms: for example, it should be suffici ently broad to establish benchmarks, determine the general stat e of the art, determine potential risk, adverse
events, undesirable side-effects, etc.
Note that a search which is restricted to the manufacturer’s ow n product or the name of their chosen equivalent could miss imp ortant information and therefore is not
acceptable.
• Databases used (to minimize bias multiple databases should be u sed).
• Acceptability of inclusion and exclusion criteria.
• Both favourable and unfavourable data included.
• Strategies for avoiding duplication of data (for example, acros s different publications or between manufacturer and published data).
• Literature search and review protocol (i.e. how did the manufac turer test this protocol to ensure comprehensive identification of relevant data / demonstrate that all relevant
data has been retrieved?).
• Any deviations from the manufacturer’s literature search protoc ol.
• Overall conclusions regarding the adequacy of search methods, l ikelihood of having retrieved all relevant data, and methods us ed to avoid bias.
Comment if systematic search and review methods such as the fol lowing have been used:
• PICO (patient characteristics, type of intervention, control, a nd outcome queries).
• Cochrane Handbook for Systematic Reviews of Interventions.
• PRISMA (The Preferred Reporting Items for Systematic Reviews an d Meta-Analyses) Statement.
• MOOSE Proposal (Meta-analysis Of Observational Studies in Epide miology).
• Other (specify or describe).
Literature searc h documentation:
☐ Literature search protocol provided
☐ Literature search reports provided
☐ Full list of retrieved articles provided
☐ Full list of excluded articles provided, with reasons for excl usion
☐ Full text copies of relevant documents available
Comments:
Provide rationale if any of the above has not been provided. Medical Devices
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Nota bene:
• A literature search and other retrieval of data should be carri ed out based on a search protocol. The search protocol should d ocument the planning of the search before execution.
• Once the searches have been executed, the adequacy of the searc hes should be verified and a literature search report should be compiled to present details of the execution, any
deviations from the literature search protocol, and the results of the search.
• It is important that the literature search is documented to suc h degree that the methods can be appraised critically, the resu lts can be verified, and the search reproduced if
necessary.
• Abstracts lack sufficient detail to allow issues to be evaluate d thoroughly and independently, but may be sufficient to allow a first evaluation of the relevance of a paper. Copies of
the full text papers and documents should be obtained for the a ppraisal stage.
• The literature search protocol(s), the literature search report (s), and full text copies of relevant documents using URL links , become part of the clinical evidence and, in turn, the
technical documentation for the medical device.
Non-compliances identified and resolved for this section may be briefly described in this box
Literature search protocol and outputs are:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Data appraisal:
Provide a brief summary of the manufacturer’s data appraisal me thods (i.e. how they determine whether the data from a given st udy or other source of data is of sufficient quality and
relevance to be included in the clinical evaluation. This inclu des evaluation of criteria incl uding study design, sources of b ias, peer review, relevance to subject device, etc. Retrieved s tudies
and data sets should be weighted on the basis of scientific qua lity and relevance to the scope and objectives of the clinical evaluation for the subject devices).
Justify the acceptability of the appraisal in terms of:
• Methodological quality and scient ific validity of articles retr ieved and evaluated appropriately.
• Relevance of the information to the clinical evaluation determi ned and documented.
• Contribution of each data set to the clinical evaluation weight ed according to systematic criteria. Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
18
Non-compliances identified and resolved for this section may be briefly described in this box
Data appraisal is:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Section E: Clinical investigations and related documentation
Has the manufacturer conducted clinical investigation(s)?
State Yes / No
Has the manufacturer conducted pre-market or post-market clinic al investigations?
Provide detail
If the manufacturer has not conducted clinical investigation: What is the rationale?
Why is this acceptable / unacceptable?
Has the manufacturer provided a c opy of all clinical investigat ion reports?
State Yes / No
Were all clinical investiga tions publicly registered?
State Yes / No
Have been verified that clinical investigations conducted with respect to Regulation (EU) 745/ 2017 publicly registered on EUDA MED?
State Yes / No Provide the EUDAMED single regist ration number where available. Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Did the clinical investigations result in a publication in a sc ientific journal?
State Yes / No If yes, does the clinical investigation report reflect the resu lts of clinical investigation(s) or other studies reported in s cientific literature, or reports published in peer reviewed sci entific
literature on other clinical experience? If there are any diffe rences describe these and summarise the rationale provided by t he manufacturer.
Has the manufacturer provided all Competent/Regulatory Authorit y correspondence (from all countries, including outside of EU)
State Yes / No
Are the conclusions drawn by the manufacturer, based upon the r esults of the clinical investiga tion, valid in the light of the approved clinical investigation plan?
Provide detail
If clinical investigations not performed under Regulation (EU) 745/2017 were not publicly registered or published:
Confirm that a rationale was provided.
Confirm that the SSCP and where relevant the IFU (for example w ith respect to the description of clinical benefits) adequately provide information for the intended user and if
relevant, the patient.
Clinical Investigation Plan (CIP) reference
CIP complies with MDR, Annex XV, and EN ISO 14155 Annex A
State Yes / No
CIP scope and study design
Adequacy of CIP scope and study design for demonstration of saf ety, performance and benefit risk of subject devices:
Study design.
Devices identified.
Patient population.
Patient numbers.
Objectives and endpoints.
Length of follow up and intervals.
Study locations.
Overall conclusions.
Non-compliances identified and resolved for this section may be briefly described in this box Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Manufacturer clinical investigati ons and related documentation are:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Section F: PMS, PMCF and the plan for updates
Documents reviewed, where relevant:
☐ PMS Plan
☐ PMS Report (where relevant)
☐ PMCF Plan
☐ PMCF Report (where relevant)
☐ PSUR (if available)
Include references to the above documents. The demonstration of equivalence and the link to post-market cl inical follow-up
Describe how the manufacturer will verify the presumption that there would be no clinically significant difference in the safe ty and clinical performance of the device under evaluation
compared with the equivalent device by post market surveillance or post market clinical follow-up?
Is there a post-market clinical follow-up planned?
State Yes / No
Is this an implantable or class III device for which clinical i nvestigations have not been perfo rmed in accordance with Articl e 61(4)?
State Yes / No
For these devices the PMCF plan should include post market clin ical studies to demonstrate the safety and performance of the d evice.
Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Clinical evaluation updates:
Identify when updates to the clinical evaluation report shall b e assessed during the surveillance and post certification monit oring activities and which frequency should be considered.
Provide further detail taking into account the manufacturer's P MCF plan and the post-market surveillance plan.
Non-compliances identified and resolved for this section may be briefly described in this box
The PMS, PMCF and the plan for updates are:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Section G: IFU, SSCP, labelling and other information supplied with the device
Information materials supplied by the manufacturer and the inst ructions for use:
Describe what has been reviewed – IFU, promotional materials (i f available), SSCP, labelling etc. In case several documents ha ve been assessed, identify answers to the questions below for
each of the documents.22
22 Note that the SSCP requires a separate validation report. Comments on appropriateness of PMS/PMCF Plan:
If no PMCF is planned, has the manufacturer provided an accepta ble justification for not conducting a PMCF?
State Yes / No
Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Intended purpose:
Does the clinical evidence support this?
Intended patient population: Who is the intended patient population? Does the clinical evidence support this?
Are all the appropriate/relevant restrictions, warnings or cont raindications in place?
Intended users:
Is the device to be used by healthcare professionals or lay use rs? Does the IFU provide all the appropriate/relevant informati on for the intended user?
Has the manufacturer taken into account the technical knowledge , experience, education, training and use environment, where ap plicable, and the medical and physical conditions of
intended users (design for lay, professional, disabled or other users).
Is any training for users required as a risk control measure? I f not, is this justified with respect to the risk management fi le and the clinical evaluation?
Limitations:
Has the manufacturer adequately/clearly described any limitatio ns for the device use?
Does the device require any specific limitations?
Contraindications: Have contraindications been adequately/clearly described?
Are any further contraindications necessary?
Warnings and precautions:
Have warnings, precautions and/or measures to be taken in the e vent of malfunction of the device or changes in its performance that may affect safety been adequately descried?
Does the information supplied by the manufacturer adequately/cl early provide the safety and performance information relevant t o the user, or any other person, as appropriate/relevant?
Is the estimation of associated risks and residual risk adequat e? Is this estimation quantitative (i.e. a percentage rate or r ate with a confidence interval) or qualitative? Is the descript ion
appropriate for patients and users? Is the information provided to the end user written in a clear and understandable way (instruction s of use, indications, and w arnings)?
Is the IFU and other information materials supplied by the manu facturer aligned with the other parts of the technical document ation?
Consider:
• the clinical evaluation (the dev ice description used for the cl inical evaluation, other content s of the clinical evaluation re port).
• the available clinical data (such as the public registration an d results of clinical investigations, publications, PMCF studie s, etc.). Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
23
• PMS report or PSUR.
• the risk management file.
Non-compliances identified and resolved for this section may be briefly described in this box
IFU, promotional materials, labelling are:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Section H: Summary of all available data and conclusions
Has the manufacturer conducted clinical investigation(s) for th e device under evaluation?
State Yes / No
Has the manufacturer demonstrated equivalence with respect to s ection 3 of Annex XIV of the MDR?
State Yes / No
If the manufacturer conducted CIs, does clinical data from clin ical investigations of the device under evaluation adequately d emonstrate compliance with the relevant general safety and
performance requirements?
State Yes / No
Has the reliability of the sourc e of clinical investigation dat a been assured through monitoring activities and verification o f the application of appropriate clinical research standards?
State Yes / No
If the manufacturer demonstrated equivalence with respect to se ction 3 of Annex XIV of the MDR does the data from an equivalen t device demonstrate compliance with Annex I? State Yes /
No Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Provide a summary of safety data (with reference to the relevan t section of the CER).
Provide a summary of performance data (with reference to the re levant section of the CER)
Does the clinical data provide su fficient clinical evidence to:23
• Demonstrate compliance with the relevant general safety and per formance requirements? State Yes / No, and provide additional i nformation if relevant
• Support the intended purpose, the claims and the information in the IFU and SSCP? State Yes / No, and provide addi tional information if relevant
What are the remaining unanswered questions regarding the devic e under evaluation?
Describe these with respect to the plan for PMS / PMCF
Overall Conclusions:
Benefit-risk conclusions:
Summarise the clinical benefits. D escribe them briefly in relat ion to the meaningful and measu rable patient relevant clinical outcomes, including outcome(s) related to diagnosis. Describe
their positive impact on patient management or public health.
Summarise the risks with clinical relevance (e.g uncertainties or limitations of clinical data, undesirable side-effects, pote ntial for misuse, etc) and provide a short description (e.g. in cidence,
severity, duration, vulnerable patient subgroups, dose-response relationship where relevant, etc).
Discuss the impact of risks (as described above) in relation to the clinical benefits taking into account the factors describe d and in particular the uncertain ties in relation to available clinical
data.
Have all the risks that could have a significant impact on the benefit-risk analysis' been identified in the clinical evaluati on?
Is there alignment between the risk management and clinical eva luation?
23 For legacy products, see MDCG 2020-6 Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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State Yes / No
Describe how the clinical benefits outweigh the risks also cons idering the current state of the art.
Have all deficiencies/non-compliances been raised and satisfact orily addressed in the course of this clinical evaluation asses sment?
State Yes / No
Is it possible to follow the changes that have been made to add ress them?
Overall conclusion on the assessment of the manufacturer's clin ical evaluation including a clinical judgement of the opinion p rovided by any external expert.
Make a clear recommendation to the notified body's decision mak er in regards to the conclusions of this assessment for the pur pose of granting certification, stating in addition:
• whether the post-market surve illance plan, including the PMCF p lan, is adequate.
• specific milestones to be set for further review of the up to d ate clinical evaluation by the notified body.
• considerations to define the period of certification.
• additional conditions on the cer tification to be considered.
Sufficient information are prov ided to demonstrate acceptabilit y of benefit-risk conclusions and confirm that the relevant MDR requirements are met : ☐
Specific Considerations
Section I: Clinical evaluation consultation procedure for certa in class III and class IIb devices (Article 54)
Is the procedure required by Article 54(1) to be applied? State Yes / No Provide further information where necessary with respect to thi s justification
If this procedure is not to be applied, with respect to Article 54(2) what is the reason?
24
24 See MDCG 2019-3, Interpretation of Article 54(2)b Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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(a) renewal of a certificate issued under the MDR; ☐
(b) the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose , and the manufacturer has demonstrated to the
satisfaction of the notified body that the modifications do not adversely affect the benefit-risk ratio of the device; ☐
Provide a summary of the modification(s) that have been made to the device?
Provide a summary of the manufacturer’s rationale demonstrating that the benefit-risk ratio of the device is not adversely aff ected.
Has the clinical data been provided to support the conclusions of the manufacturer regarding the benefit-risk of the modified device with respect to the previous version?
For legacy devices, verify:
that the modifications do not adversely affect the benefit-risk ratio.
that the device in question had a valid certificate under the D irectives.
in case the certificate has been withdrawn, suspended
25 or expired, if there is an impact on compliance with the gener al safety and performance requirements, and
that there is no pending assessment of changes for the device o r outstanding non-compliance.
the description of modifications provided and assess if these m odifications are limited only to those needed in order to compl y with the new legal requirements introduced by the MDR.
Note: limitations of the intended purpose of the device should not trigger the consultation procedure in accordance to Art. 54 .
(c) the principles of the clinical evaluation of the device typ e or category have been addressed in a CS referred to in Articl e 9 and the notified body confir ms that the clinical evaluation of
the manufacturer for this device is in compliance with the rele vant CS for clinical evaluation of that kind of device. ☐
Relevant scientific panel and associated competence area(s)
Indicate your opinion on the r elevant scientific and associated competence area(s) for the device under assessment:
Medical area(s) Associated competence-related areas
Orthopaedics, traumatology, rehabilitation,
rheumatology Joint replacements (hip, knee, shoulder)
Spinal devices
Non-articulating devices, rehabilitation
Other
25 The devices for which the certificates were withdrawn or suspe nded due to lack of compliance wi th essential requirements will require a clinical evaluation consultation procedure as this
adversely affects the benefit-risk ratio of the device. Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Circulatory system: cardiovascular / lymphatic
system Prosthetic heart valves and devices for heart valve repair
Cardiovascular stents (metallic and bioresorbable) and vascular prostheses
Active implantable cardiac devic es and electrophysiological dev ices
Structural interventions and new devices (e.g. LAA/PFO occluder s, heart failure devices)
Cardiac surgery including extracorporeal membrane oxygenation, cardiopulmonary bypass devices, artificial hearts (and
left ventricular assist devices)
Other
Respiratory, anaesthesiology, intensive care Respiratory and anaesthetic devices
Neurology Central and peripheral nervous system devices
Implants for hearing and vision (sensory recovery)
Neurosurgical devices
Other
Endocrinology and diabetes Endocrinology and diabetes (e.g. insulin delivery systems and c losed-loop systems, continuous glucose monitoring)
Implantable systems
General and plastic surgery, dentistry Surgical implants and general surgery
Plastic surgery and wound care
Maxillofacial surgery
Dentistry (devices for dentistry (oral surgery, implantology, d ental materials incl.))
Other
Obstetrics & gynaecology including reproductive
medicine Devices for obstetrics and gynaecology
Gastroenterology & hepatology Devices for gastroente rology and hepatology
Nephrology & urology Devices for nephrology and urology
Ophthalmology Devices for ophthalmology Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Provide further information necessary with respect to this just ification
Conclusion for certain class III and IIb devices to be consider ed by the expert panel
Novel aspects
See section C, subsection ‘Novelty’
Benefit-risk determination See section H and the Overall Conclusion sections
Consistency of clinical evidence with intended purpose and PMCF
Provide an assessment of the consistency of the clinical eviden ce with:
(a) the intended purpose, including medical indication(s),
(b) the post-market clinical follow-up (PMCF) plan.
Section J: Where demonstration o f conformity based on clinical data is not deemed appropriate (Article 61(10))
Has the manufacturer claimed that the demonstration of conformi ty with general safety and performance requirements based on cl inical data is not deemed appropriate in accordance
with Article 61(10)?
State Yes / No
Nota bene : A clinical evaluation is still required and the above informa tion and evidence-based justifica tion shall be presented in the clinical evaluation report.
Has the manufacturer provided a justification for reliance upon Article 61(10)?
State Yes / No
If yes, describe the evidence which the manufacturer is relying on, w ith respect to:
Performance evaluation
Bench testing Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Pre-clinical evaluation
Consider:
Has any available clinical data for the device or an equivalent device been searched for and/or identified by the manufacturer ?
If yes –was the identified clinic al data integrated in the clin ical evaluation.
This should include an evaluation of clinical data identified f rom the literature, and an appraisal of their relevance to the device under evaluation.
Is clinical data available for si milar devices, does this provi de information with relevant to the safety and performance of t he device under evaluation?
Has the manufacturer conducted an appropriate search of scienti fic literature?
If clinical data for similar devi ces is available – this should be included in the CER and evaluated and may be of particular relevance to post-market surveillance / PMCF planning.
The results of the manufacturer's risk management
Are the results of the manufacturer's risk management supportiv e of the use of non-clinical testing methods?
Consideration of the specifics of the interaction between the d evice and the human body
Is the device under assessment part of a system or stand-alone?
Is there sufficient information regarding this interaction avai lable from sources other than clinical data?
The clinical performance intended
What is the intended performance? Is it reasonable to rely upon non-clinical data for the proposed intended performance?
The claims of the manufacturer
The manufacturer should not make any claims which are not suppo rted by clinical data.
Overall conclusion
Non-compliances identified and resolved for this section may be briefly described in this box
The justification of the manufacturer for reliance upon Article 61(10) is:
Compliant with the applicable requirements of the MDR: ☐
Include any relevant comments
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ Medical Devices
Medical Devices Coordination Group Document MDCG 2020-13
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Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the
manufacturer.
Section K: The voluntary clinical consultation on the clinical development strategy (Article 61(2))
Expert Panel consultation reference:
Expert Panel recommendations:
Have the views of the expert panel been given due consideration by the manufacturer?
Has this been included in the clinical evaluation report?
Is there any divergence between the manufacturers clinical deve lopment strategy and the views of the expert panel? If yes – wh at is the justification for this? Is this acceptable? Explain
why. |
MDCG 2020-1.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2020-1
MDCG 2020-1
Guidance on Clinical Evaluation (MDR)
/ Performance Evaluation (IVDR) of
Medical Device Software
March 2020
This document has been endorsed by the Medical Device Coordination Group (MDCG)
established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of
representatives of all Member States and it is chaired by a representative of the European
Commission.
The document is not a European Commission document and it cannot be regarded as reflecting
the official position of the European Commission. Any views expressed in this document are not
legally binding and only the Court of Justice of the European Union can give binding
interpretations of Union law.
Page 1 of 21
Guidance on
Clinical Evaluation/
Performance
Evaluation of
Medical Device
Software
March 2020
Guidance on Clinical Evaluation
(MDR) / Performance Evaluation
(IVDR) of Medical Device Software
Page 2 of 21
Table of Contents
1. Purpose ............................................................................................................................................ 3
2. Scope ............................................................................................................................................... 3
3. Background ..................................................................................................................................... 4
3.1. Abbreviations ........................................................................................................................... 5
3.2. Formats used within this document........................................................................................... 5
3.3. Definitions ............................................................................................................................... 5
4. General principles of the MDSW CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION
(IVDR) process ....................................................................................................................................... 9
4.1. Introduction ............................................................................................................................. 9
4.2. Determination of the valid clinical association / scientific validity .......................................... 12
4.3. Technical Performance /Analytical Performance .................................................................... 12
4.4. Clinical Performance .............................................................................................................. 13
4.4.1. Clinical investigations and clinical performance studies .................................................. 14
4.4.2. Where demonstration of conformity based on clinical data is not deemed appropriate ..... 15
4.5. Final analysis and conclusion of the clinical evaluation (MDR) / performance evaluation
(IVDR) .............................................................................................................................................. 15
4.6. Continuous update of the clinical evaluation (MDR) / performance evaluation (IVDR)........... 15
Annex I – Methodological principle for generation of CLINICAL EVIDENCE ........................................ 17
Annex II – Examples of CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR)
strategies ........................................................................................................................................... 18
a) MDSW intended to analyse sleep quality data .................................................................... 18
b) MDSW intended for image segmentation ............................................................................ 19
c) MDSW intended to detect inflammatory bowel diseases (IBD) .......................................... 20
d) Active devices containing MDSW to enable their intended purpose .................................. 21
e) MDSW which provides an additional user-interface to control an insulin pump ............... 21
f) MDSW intended to analyse exhaled CO2 in a life-sustaining device in order to control
ventilator settings ......................................................................................................................... 21
Page 3 of 21
1. Purpose
The purpose of this guidance is to provide a framework for the determination of the appropriate level of
CLINICAL EVIDENCE required for MEDICAL DEVICE SOFTWARE (MDSW) to fulfil the requirements set out
in Regulation (EU) 2017/745 – Medical Devices Regulation (MDR) and Regulation (EU) 2017/746 – In
Vitro Diagnostic Medical Devices Regulation (IVDR).1
In order to promote global convergence, this document takes into account certain concepts outlined in
International Medical Device Regulators Forum (IMDRF) guidance documents (such as N41).2
2. Scope
This guidance should be applied to MDSW. For the purpose of this guidance, MDSW is software that is
intended to be used, alone or in combination, for a purpose as specified in the definition of a “medical
device” in the medical devices regulation or in vitro diagnostic medical devices regulation.
It should be noted that software can be associated3 with another medical device, by driving or influencing
its use. The guideline MDCG 2019-11 clarifies that software which is driving or influencing is covered by
the medical devices regulations4 either as a part/component of a device or as an accessory for a medical
device.
Software developers should refer to MDCG 2019-11 for guidance on the appropriate qualification and
classification of software prior to such software being introduced into the market. The same principles of
CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) apply to all MDSW. Conceptually,
the following models of software can be understood (whereas combinations may be possible, refer to Table
1):
a) Software for which the manufacturer claims a specific medical intended purpose. Such software
has a CLINICAL BENEFIT and requires CLINICAL EVIDENCE within its own conformity assessment.
b) Software for which the manufacturer does not claim any medical intended purpose. Such software
is intended to drive or influence a medical device. The CLINICAL EVIDENCE is provided within the
context of the driven or influenced device and is therefore out of the scope of this document.
It should be recognised that the concept of a CLINICAL BENEFIT for MDSW may deviate from that which
applies in the case of pharmaceuticals or other medical devices, since the benefit of MDSW may lie in
providing accurate medical information on patients, where appropriate, assessed against medical
information obtained through the use of other diagnostic options and technologies, whereas the final clinical
outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be
available.
1 Depending on the device in question, the level of Clinical Evidence may differ and shall be assessed on a case by case basis.
2 International Medical Device Regulators Forum – IMDRF/SaMD WG/N41FINAL:2017 – Guidance on Software as a Medical
Device (SaMD): Clinical Evaluation
3 Associated medical device may be software or hardware.
4 The use of “The Medical Devices Regulations” from here on out refers to both Regulation (EU) 2017/745 – MDR and Regulation
(EU) 2017/746 – IVDR.
Page 4 of 21
Model of Software CLINICAL EVALUATION (MDR) /
PERFORMANCE EVALUATION
(IVDR) - scope
MDSW
(with independent intended purpose and claimed CLINICAL
BENEFIT) MDSW only
MDSW
(with intended purpose and claimed CLINICAL BENEFIT related
to driving or influencing a medical device for a medical
purpose) MDSW and the driven or influenced
medical device Notes 1,2
Software driving or influencing the use of a medical device
(with no independent intended purpose or independent claimed
CLINICAL BENEFIT ) Driven or influenced medical device
including the software (component or
accessory)
Table 1 Different MDSW and CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR)
requirements
Note 1: If a software is driving/ influencing more than one medical device, an independent CLINICAL
EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) is required for each foreseen and clinically
viable software – device combination.
Note 2: Out of scope of this guidance (See MDCG 2019-11 for examples).
3. Background
Article 61 (1) of the MDR and Article 56 (1) of the IVDR state the following:
‘The manufacturer shall specify and justify the level of CLINICAL EVIDENCE necessary to
demonstrate conformity with the relevant general safety and performance requirements. That level
of CLINICAL EVIDENCE shall be appropriate in view of the characteristics of the device and its
intended purpose.’
Article 2 (51) of the MDR and Article 2 (36) of the IVDR define ‘ CLINICAL EVIDENCE ’ as:
‘clinical data and CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) results
pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether
the device is safe and achieves the intended CLINICAL BENEFIT (S), when used as intended by the
manufacturer.’
In order to provide guidance relating to the level of CLINICAL EVIDENCE required for MDSW and as set out
in recital (5) of the MDR and IVDR, this guidance takes into account internationally converged principles
adopted by an international group of regulators, IMDRF ( http://www.imdrf.org ). Adoption of these
principles provides European regulators an initial framework when further developing MDR/ IVDR-
specific regulatory approaches and expectations for regulatory oversight.
While this document describes a converged approach to CLINICAL EVALUATION (MDR) / PERFORMANCE
EVALUATION (IVDR) for MDSW , it should be read in conjunction with other documents that aim to provide
Page 5 of 21
horizontal guidance for the CLINICAL EVALUATION of medical devices or PERFORMANCE EVALUATION of
in vitro diagnostic medical devices.5
Note: Please be advised that this document is subject to revision upon the publication of the aforementioned
horizontal guidance.
Clinical expertise and judgments are required at every step of the CLINICAL EVALUATION (MDR) /
PERFORMANCE EVALUATION (IVDR), including literature search and appraisal. Each indication and
claimed CLINICAL BENEFIT that is part of the intended purpose should be assessed individually and have
the supporting CLINICAL EVIDENCE . Systematic and explicit approach for the appraisal of supporting data
allows achieving confident, scientifically substantiated conclusions and facilitates transparency of these
judgments.
3.1. Abbreviations
GSPR General Safety and Performance Requirements
IMDRF International Medical Device Regulators Forum
IVDR In Vitro Diagnostic Medical Devices Regulation; EU 2017/746
MDCG Medical Device Coordination Group
MDR Medical Devices Regulation; EU 2017/745
MDSW Medical Device Software
PMCF Post Market Clinical Follow -up
PMPF Post Market Performance Follow -up
PMS Post Market Surveillance
RWE Real-World Evidence
SaMD Software as a Medical Device
SOTA State-of-the-Art
SSCP Summary of Safety and Clinical Performance
SSP Summary of Safety and Performance
3.2. Formats used within this document
Cursive A note to a text
CAPITALIZED Terms defined in this document or the Regulations
subscript References
3.3. Definitions
The definitions elaborated within this section and utilised within this document are intended to apply
solely to Medical Device Software (MDSW) according to the MDR and IVDR.
5 These guidance documents are under development and will be published on the Commission’s Medical Devices website.
Page 6 of 21
CLINICAL BENEFIT Article 2 (53) MDR defines CLINICAL BENEFIT as the positive impact
of a device on the health of an individual, expressed in the terms of a
meaningful, measurable, patient-relevant clinical outcome(s),
including outcome(s) related to diagnosis, or a positive impact on
patient management or public health; whereas
Article 2 (37) IVDR defines CLINICAL BENEFIT as the positive impact
of a device related to its function, such as that of screening,
monitoring, diagnosis or aid to diagnosis of patients, or a positive
impact on patient management or public health.6
Source: EU 2017/745 (MDR), Article 2 (53); EU 2017/746 (IVDR), Article 2 (37) and IVDR recital (64)
CLINICAL DATA (MDR) Information concerning safety or performance that is
generated from the use of a device and is sourced from the following:
- clinical investigation(s) of the device concerned,
- clinical investigation(s) or other studies reported in scientific
literature, of a device for which equivalence to the device in
question can be demonstrated,
- reports published in peer reviewed scientific literature on
other clinical experience of either the device in question or a
device for which equivalence to the device in question can
be demonstrated,
- clinically relevant information coming from post-market
surveillance, in particular the post-market clinical follow-up;
Source: EU 2017/745 (MDR)
(IVDR) Clinical Data, in particular:
- from relevant peer-reviewed scientific literature and
available consensus expert opinions or positions from
relevant professional associations relating to the safety,
performance, clinical benefits to patients, design
characteristics, scientific validity, clinical performance and
intended purpose of the device and/or of equivalent or similar
devices; or
- other relevant clinical data available relating to the safety,
scientific validity, clinical performance, clinical benefits to
patients, design characteristics and intended purpose of
similar devices, including details of their similarities and
differences with the device in question
- clinically relevant information coming from post-market
surveillance, in particular the post-market performance
follow-up;
Source: Adopted from EU 2017/746 (IVDR) Annex XIV (2.4) and Annex VII (4.10) and (4.1 1)
6 IVDR recital (64) states : It should be recognised that the concept of clinical benefit for in vitro diagnostic medical devices is
fundamentally different from that which applies in the case of pharmaceuticals or of therapeutic medical devices, since the benefit
of in vitro diagnostic medical devices lies in providing accurate medical information on patients, where appropriate, assessed
against medical information obtained through the use of other diagnostic options and technologies, whereas the final clinical
outcome for the patient is dependent on further diagnostic and/or therapeutic options which could be available.
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CLINICAL DEVELOPMENT PLAN
(MDR) A plan indicating progression from exploratory investigations, such
as first-in-man studies, feasibility and pilot studies, to confirmatory
investigations, such as pivotal clinical investigations and a PMCF
with an indication of milestones and a description of potential
acceptance criteria.
Source: EU 2017/745 (MDR), Annex XIV, part A
CLINICAL EVALUATION (MDR) A systematic and planned process to continuously generate, collect,
analyse and assess the clinical data pertaining to a device in order to
verify the safety and performance, including CLINICAL BENEFITS , of
the device when used as intended by the manufacturer.
Source: EU 2017/745 (MDR), Article 2 (44)
CLINICAL EVIDENCE Clinical data and CLINICAL EVALUATION (MDR) / PERFORMANCE
EVALUATION (IVDR) results pertaining to a device of a sufficient
amount and quality to allow a qualified assessment of whether the
device is safe and achieves the intended CLINICAL BENEFIT (S), when
used as intended by the manufacturer.
Source: EU 2017/745 (MDR), Article 2 (51)); EU 2017/746 (IVDR), Article 2 (36)
CLINICAL INVESTIGATION
(MDR) Any systematic investigation involving one or more human subjects,
undertaken to assess the safety or performance of a device.
Source: EU 2017/745 (MDR), Article 2 (45)
CLINICAL PERFORMANCE Article 2 (52) MDR defines clinical performance as the ability of a
device, resulting from any direct or indirect medical effects which
stem from its technical or functional characteristics, including
diagnostic characteristics, to achieve its intended purpose as claimed
by the manufacturer, thereby leading to a CLINICAL BENEFIT for
patients, when used as intended by the manufacturer; whereas
Article 2 (41) IVDR defines clinical performance as the ability of a
device to yield results that are correlated with a particular clinical
condition or a physiological or pathological process or state in
accordance with the target population and intended user.
Source: EU 2017/745 (MDR), Article 2 (52); EU 2017/746 (IVDR), Article 2 (41)
CURATED DATABASE / CURATED
REGISTRY For the purpose of this document, a curated database /curated registry
is any kind of structured repository such as a traditional database, an
ontology or an XML file, that is created and updated with a great deal
of human effort through the consultation, verification, and
aggregation of existing sources, and the interpretation of new (often
experimentally obtained) raw data.
GENERALISABILITY Generalisability refers to the ability of a MDSW to extend the
intended performance tested on a specified set of data to the broader
intended population.
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HUMAN FACTORS ENGINEERING Human factors engineering refers to the a pplication of knowledge
about human behaviour, abilities, limitations, and other
characteristics to the design of and interactions with a MDSW to
achieve adequate USABILITY .
PERFORMANCE EVALUATION
(IVDR) An assessment and analysis of data to establish or verify the
SCIENTIFIC VALIDITY , the ANALYTICAL and, where applicable, the
CLINICAL PERFORMANCE of a device.
Source: EU 2017/746 (IVDR), Article 2 (44)
PERFORMANCE STUDY (IVDR) A study undertaken to establish or confirm the analytical or CLINICAL
PERFORMANCE of a device.
Source: EU 2017/746 (IVDR), Article 2 (42)
REAL-WORLD PERFORMANCE Information on real -world device use and performance from a wider
patient population than a controlled study.
Source: Definition derived from IMDRF/SaMD WG/N41FINAL:2017
STATE-OF-THE-ART Developed stage of current technical capability and/or accepted
clinical practice in regard to products, processes and patient
management, based on the relevant consolidated findings of science,
technology and experience.
Note: The STATE-OF-THE-ART embodies what is currently and
generally accepted as good practice in technology and medicine. The
state-of-the-art does not necessarily imply the most technologically
advanced solution. The STATE-OF-THE-ART described here is
sometimes referred to as the “generally acknowledged STATE-OF-
THE-ART”
Source: Modified from IMDRF/GRRP WG/N47 FINAL:2018
TECHNICAL PERFORMANCE
(MDR) /ANALYTICAL (IVDR))
PERFORMANCE Capability of a MDSW to accurately and reliably generate the
intended technical/analytical output from the input data.
Source: IMDRF/SaMD WG/N41FINAL:2017
Source: EU 2017/746 (IVDR) Article 2 (40)
USABILITY For the purpose of this document, usability refers to the c haracteristic
of the user interface that establishes effectiveness, efficiency and ease
of user learning and user satisfaction.
VALID CLINICAL ASSOCIATION
(MDR) / SCIENTIFIC VALIDITY
(IVDR) Means the association of an MDSW output with a clinical condition
or physiological state.
Source: Derived from IMDRF/SaMD WG/N41FINAL:2017
Source: EU 2017/746 (IVDR), Article 2 (38)
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4. General principles of the MDSW CLINICAL EVALUATION (MDR) /
PERFORMANCE EVALUATION (IVDR) process
4.1. Introduction
CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) is an ongoing process, conducted
throughout the life cycle of a MDSW. It is a structured, transparent, iterative and continuous process which
is part of the quality management system for a device. Software that qualifies as a MD or an IVD is subject
to the same general CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) principles, laid
down in the applicable guidelines and regulatory documents, as other MDs/ IVDs, such as:
- Establishing and maintaining a CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION
(IVDR) plan and criteria applied to generate the necessary CLINICAL EVIDENCE based on the
characteristics of the device;
- Identification of the relevant data pertaining to performance and/ or safety of the device and any
remaining unaddressed issues or gaps in the data;
- Appraisal of the relevant data in terms of quality and its contribution to the CLINICAL EVALUATION
(MDR) / PERFORMANCE EVALUATION (IVDR);
- Analysis of the available data and its relevance with regard to demonstrating conformity with the
relevant General Safety and Performance Requirements (GSPRs);
- Documenting the relevant data, their assessment and the CLINICAL EVIDENCE derived therefrom, in
the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) report;
- Updating the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) and its
documentation throughout the life cycle of the MDSW concerned with data obtained from
implementation of the manufacturer's Post Market Clinical Follow-up / Post Market Performance
Follow-up (PMCF /PMPF) plan.
These methodological principles are depicted in Figure 1.
Figure 1 Overview of the stages of the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR)
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The requirements for CLINICAL EVALUATION and PERFORMANCE EVALUATION are outlined in Article 61 of
the MDR (including Annex XIV) and Article 56 of the IVDR (including Annex XIII), respectively.
While the definition of CLINICAL EVALUATION in the MDR and PERFORMANCE EVALUATION in the IVDR
are not identical (see section 0), there is a shared expectation for providing sufficient CLINICAL EVIDENCE
to demonstrate conformity with relevant GSPRs under the normal conditions of the device’s intended use.
CLINICAL EVIDENCE should be sufficient and appropriate in view of the characteristics of the device, clinical
risks and its intended purpose. The level of CLINICAL EVIDENCE necessary should be specified and justified
by the manufacturer.
Three key components should be taken into account when compiling CLINICAL EVIDENCE for every MDSW
(Figure 1), and each is described below in further detail.
VALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY is understood as the extent to which, the MDSW’s
output (e.g. concept, conclusion, calculations) based on the inputs and algorithms selected, is associated
with the targeted physiological state or clinical condition. This association should be well founded or
clinically accepted (e.g. existence of a scientific framework or sufficient level of evidence as further
elaborated in section 4.2 of this document). The V ALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY of
a MDSW should demonstrate that it corresponds to the clinical situation, condition, indication or parameter
defined in the intended purpose of the MDSW.
NOTE: The VALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY seeks to establish that there are sound
scientific principles underpinning the use of the MDSW in question. The information provided for the
establishment of the V ALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY should put forward the case that
the MDSW has an association with a clinical condition or physiological state. This association may not
always be readily established. Thus, the C LINICAL PERFORMANCE can serve as an additional input to the
VALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY from a clinical perspective for the specific intended
purpose (see Annex I).
Example: MDSW that detects heart arrhythmia by analysing auscultation sound obtained by a digital
stethoscope requires demonstrating VALID CLINICAL ASSOCIATION of the association between abnormal
cardiac sounds and heart arrhythmia.
Evidence supporting VALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY can be generated e.g. through
literature research, professional guidelines, proof of concept studies, or manufacturer’s own clinical
investigations/clinical performance studies.
Validation of the TECHNICAL PERFORMANCE / ANALYTICAL PERFORMANCE is the demonstration of the
MDSW’s ability to accurately, reliably and precisely generate the intended output, from the input data.
Evidence supporting T ECHNICAL PERFORMANCE / ANALYTICAL PERFORMANCE can be generated through
verification and validation activities, e.g. unit-level, integration, and system testing or by generating new
evidence through use of curated databases, curated registries, reference databases or use of previously
collected patient data.
Validation of the CLINICAL PERFORMANCE is the demonstration of a MDSW’s ability to yield clinically
relevant output in accordance with the intended purpose. The clinical relevance of a MDSW’s output is a
positive impact
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- on the health of an individual expressed in terms of measurable, patient-relevant clinical
outcome(s), including outcome(s) related to diagnosis, prediction of risk, prediction of
treatment response(s), or
- related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis
of patients, or
- on patient management or public health.
Evidence supporting C LINICAL PERFORMANCE can be generated by testing the MDSW under evaluation,
or an equivalent device, in the target population and for the intended use. The applied methodology should
be appropriate in light of the device characteristics and intended purpose and may include pre-clinical
testing, a clinical investigation or a clinical performance study.
Specifically, for MDSW not claiming C LINICAL BENEFITS that can be specified through measurable,
patient-relevant clinical outcome(s), clinically relevant outputs are achieved through demonstrated
predictable and reliable use and USABILITY (please refer to section 4.2 of this document).
In addition, CLINICAL EVALUATION or PERFORMANCE EVALUATION of MDSW must consider the benefit-
risk ratio in light of the STATE-OF-THE-ART related to practice of medicine for diagnosis, treatment or patient
management. It is further expected that the assessment of MDSW considers all components of the CLINICAL
EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR) (see Figure 1 and Annex 0).
The three components described above do not represent a distinct stepwise approach but rather portray a
methodological principle for the generation of CLINICAL EVIDENCE .
To determine and justify the level of CLINICAL EVIDENCE , both amount and quality of supporting data
should be evaluated. This assessment may be guided by the following non-exhaustive questions:
Sufficient amount
- Does the data support the intended use, indications, target groups, clinical claims and
contraindications?
- Have the clinical risks and analytical performance/ clinical performance been investigated?
- Have relevant MDSW’s characteristics, such as the data input and output, the applied algorithms
or type of interconnection been considered when generating the data to support the performance of
the device?
- What is the grade of innovation/ history on the market (how big is the body of scientific evidence)?
- Other, as applicable.
Sufficient quality
- Were the type and the design of the study/ test appropriate to meet the research objectives?
- Was the data set appropriate and actual (state of the art)?
- Was the statistical approach appropriate to reach a valid conclusion?
- Were all ethical, legal and regulatory considerations/ requirements taken into account?
- Is there any conflict of interest?
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- Other, as applicable.
4.2. Determination of the valid clinical association / scientific validity
In the first step, the manufacturer should verify the association between the output of the MDSW (based on
the inputs and algorithms selected) and the targeted physiological/ clinical condition, clinical situation or
clinical parameter, as defined in the intended purpose of the MDSW. MDSW may include a multitude of
clinical features governed by its intended purpose which require individual assessment.
This association should be clinically accepted or well founded, which means accepted by the broad medical
community and/or described in scientific (peer-reviewed) literature.
VALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY can be demonstrated through the use of existing
CLINICAL PERFORMANCE DATA while taking into account the generally acknowledged STATE-OF-THE-ART.
VALID CLINICAL ASSOCIATION / SCIENTIFIC VALIDITY may further be demonstrated by the creation of new
CLINICAL PERFORMANCE DATA in the cases where existing data is not sufficient. For example, as a result
of a gap analysis, the manufacturer could conclude that additional data may be required.
Examples of existing data (in no particular order)
- Technical standards
- Professional medical society guidelines
- Systematic scientific literature review
- CLINICAL INVESTIGATION s/ CLINICAL PERFORMANCE STUDIES
- Published CLINICAL DATA (e.g. Summary of Safety and Clinical Performance (SSCP) / Summary
of Safety and Performance (SSP), Registries and databases from authorities)
Examples of generating new evidence (in no particular order)
- Secondary data analysis (Analysis of real-world data)
- Perform CLINICAL INVESTIGATION / CLINICAL PERFORMANCE STUDY
4.3. Technical Performance /Analytical Performance
The manufacturer should verify that the MDSW reliably, accurately and consistently meets the intended
purpose in real-world usage.
The relevant performance characteristics, as part of the GSPRs and linked to the analytical and / or clinical
features, should be supported by evidence generated during verification and validation activities as part of
good manufacturing practices for software, or by generating new evidence through the use of curated
databases, curated registries, reference databases or use of previously collected patient data.
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TECHNICAL PERFORMANCE / ANALYTICAL PERFORMANCE is confirmed by the examination and provision
of objective evidence that the MDSW specifications conform to user needs and intended uses, and that the
requirements implemented can be consistently fulfilled.7
For example, performance verification and validation in the intended computing8 and use environments9,10
can be characterised by the demonstration of
- availability,
- confidentiality,
- integrity,
- reliability,
- accuracy (resulting from trueness and precision),
- analytical sensitivity,
- limit of detection,
- limit of quantitation,
- analytical specificity,
- linearity,
- cut-off value(s),
- measuring interval (range),
- GENERALISABILITY ,
- expected data rate or quality,
- absence of inacceptable cybersecurity vulnerabilities,
- HUMAN FACTORS ENGINEERING .
Identification of gaps during the validation of the T ECHNICAL PERFORMANCE /ANALYTICAL
PERFORMANCE could require generation of new evidence, for example, to demonstrate generalisability with
real-life datasets or to extend the usability evaluation to omitted user groups.
4.4. Clinical Performance
For the validation of a MDSW’s CLINICAL PERFORMANCE , the manufacturer should demonstrate that the
MDSW has been tested for the intended use(s), target population(s), use condition(s), operating- and use
environment(s) and with all intended user group(s). Section 4.1 of this document further provides context
that validation of C LINICAL PERFORMANCE includes the assessment of clinical safety, effectiveness,
performance and can support the demonstration of CLINICAL BENEFIT . Validation of the CLINICAL
PERFORMANCE should be considered at each change of the software to a new release. If no validation is
performed, a justification should be stated in the technical documentation.
With a validation of C LINICAL PERFORMANCE , it is demonstrated that users can achieve clinically relevant
outputs through predictable and reliable use of the MDSW.
7 Derived from Source: GHTF/SG3/N18:2010.
8 Computing environment: e.g., hardware, memory size, processing unit, time zone, network infrastructure) under which the
software is to perform.
9 Use environment: actual conditions and setting in which users interact with the medical device.
10 Example on operating environments with distinct requirements are cloud or remote networks.
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The manufacturer should consider the intended use(s), indication(s), desired clinical output(s) expressed as
claims, leading to expected CLINICAL BENEFIT s as part of the CLINICAL PERFORMANCE validation.
A MDSW may have multiple features with only some features claiming a specific CLINICAL BENEFIT .
CLINICAL PERFORMANCE is only applicable to those features. Since MDSW can be modular in nature,
validation of the C LINICAL PERFORMANCE is also permissible on module level when the functionality of
the modules is independent of the other modules. This would allow the confirmation of a continuous benefit
/ risk acceptability only for the MDSW modules that have changed. In cases where the final combination
of modules changes product indications and intended purposes, the performance of that final product
configuration should also be evaluated. Validation of the C LINICAL PERFORMANCE can be characterised by
the demonstration of applicable C LINICAL DATA to the MDSW in question, such as (non-exhaustive):
- clinical/ diagnostic sensitivity,
- clinical/ diagnostic specificity,
- positive predictive value,
- negative predictive value,
- number needed to treat (average number of patients that need to be diagnosed/ treated in order to
have an impact on one person),
- number needed to harm (number of patients that need to be diagnosed/ treated in order have an
adverse effect on one patient),
- positive likelihood ratio,
- negative likelihood ratio,
- odds ratio,
- USABILITY / user interface,
- confidence interval(s).
CLINICAL DATA can be obtained by one or multiple methods such as those referred to in
GHTF/SG5/N7:2012 and IMDRF/SaMD WG/N41FINAL:2017.
In addition to the considerations above, C LINICAL EVALUATION of class III and implantable devices
(MDR), shall include data from a C LINICAL INVESTIGATION unless the conditions of Article 61(4), (5) or
(6) of the MDR have been fulfilled.
For MDSW falling under the IVDR, the evaluation of clinical performance requires the carrying out of
clinical performance studies regardless of the classification of the device, unless due justification is
provided for relying on other sources of clinical performance data.
Relevant common specifications should be taken into account.
4.4.1. Clinical investigations and clinical performance studies
The practical and achievable benefits of a C LINICAL INVESTIGATION / CLINICAL PERFORMANCE STUDY
should be considered as part of determining what data are needed for demonstrating the safety and
performance of a new or modified MDSW. The investigation or study should account for potential risks,
should follow appropriate ethical requirements, and should be compliant with all relevant legal and
regulatory requirements.
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MDSW has specific characteristics that should be considered when setting up a clinical investigation or
clinical performance study. If the MDSW is used for the determination of a patient’s future state (e.g.
predisposition, prognosis, prediction) or if the output of the MDSW impacts clinical outcomes (e.g.
treatment efficacy) or patient management decisions, then a prospective study may be required as part of
the device’s CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR). In other situations,
retrospective analysis may be more appropriate to generate the necessary data to support compliance with
the GSPRs, as there is no impact on patient management and the research does not introduce any risks to
the patients. Such an approach is only possible under condition that there is an adequate access to data sets
of sufficient amount and quality and obtained from the target population.
Formal requirements of MDR Articles 62 (1), 74 and 82 need to be met as far as appropriate for pre-market
retrospective studies of MDSW falling under the MDR.
4.4.2. Where demonstration of conformity based on clinical data is not deemed appropriate
In line with the provisions of MDR Article 61 (1) and IVDR Article 56(1), the level of CLINICAL EVIDENCE
required should be appropriate in view of the device claims and characteristics. For medical devices, where
the demonstration of conformity with GSPRs based on clinical data is not deemed appropriate (MDR
Article 61 (10)), the manufacturer shall duly substantiate in the technical documentation why it is adequate
to demonstrate conformity based on the results of non-clinical testing methods alone, including
PERFORMANCE EVALUATION , bench testing and preclinical evaluation, and USABILITY assessment.
The justification must be based on the output of the risk management process. This should include an
evaluation of clinical STATE-OF-THE-ART, including alternative diagnostic and treatment options, including
those identified from literature, and an appraisal of their relevance to the device under evaluation. The
device / body interaction, the CLINICAL PERFORMANCE s intended, and the claims of the manufacturer should
be specifically considered.
A CLINICAL EVALUATION (MDR) is still required, and the above information and evidence-based
justification should be presented in the clinical evaluation report.
Similarly for IVDs, where due to specific device characteristics, demonstration of conformity with GSPRs
based on clinical data is not deemed appropriate, a PERFORMANCE EVALUATION (IVDR) is still required
and a justification shall be provided and documented in the Performance Evaluation Plan and the
corresponding Performance Evaluation Report.
4.5. Final analysis and conclusion of the clinical evaluation (MDR) /
performance evaluation (IVDR)
The manufacturer should compile evidence, perform the benefit-risk analysis and document the CLINICAL
or PERFORMANCE EVALUATION and its output in the CLINICAL EVALUATION (MDR) / PERFORMANCE
EVALUATION (IVDR) report.
4.6. Continuous update of the clinical evaluation (MDR) / performance
evaluation (IVDR)
The safety, effectiveness and performance of the MDSW should be actively and continuously monitored
by the manufacturer.
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Such data may include, but is not limited to post-market information such as complaints, PMCF/ PMPF
data, REAL-WORLD PERFORMANCE data, direct end-user feedback or newly published research / guidelines
and should be subject to the CLINICAL EVALUATION (MDR) / PERFORMANCE EVALUATION (IVDR)
principles depicted in Figure 1.
The unique level of connectivity of MDSW facilitates access to REAL-WORLD PERFORMANCE data, which
can be used for multiple purposes, including, but not limited to
- timely detection and correction of malfunctions;
- detection of systematic misuse;
- understanding user interactions;
- to conduct ongoing monitoring of CLINICAL PERFORMANCE ;
- to improve effectiveness;
- develop the claims in the CLINICAL DEVELOPMENT PLAN (MDR) or future releases.
MDSW can be released for CE marking with initially claimed and validated CLINICAL BENEFITS .
Monitoring of REAL-WORLD PERFORMANCE data can help formulate hypotheses about future MDSW
functionalities and intended use(s).
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Annex I – Methodological principle for generation of CLINICAL EVIDENCE
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Annex II – Examples of CLINICAL EVALUATION (MDR) / PERFORMANCE
EVALUATION (IVDR) strategies
The high-level examples provided here are for guidance purposes only and aim to provide general
indications on how to develop a CLINICAL EVALUATION / PERFORMANCE EVALUATION strategy. The
strategy presented in each example is not a confirmation of the pathway for a CLINICAL EVALUATION /
PERFORMANCE EVALUATION of the device, as other factors need to be considered.
Moreover, the proposed pathway reflects the specific intended purpose, or the healthcare context or
situation, in which the device is used as described in the example itself. Any change to the intended purpose
or the healthcare context / situation in which that same device is used might result in a different approach.
Data source Examples
Peer-reviewed, relevant scientific literature - Existing data from studies conducted
with the subject device or equivalent
device
CLINICAL INVESTIGATION / CLINICAL
PERFORMANCE STUDIES - Prospective or retrospective studies
- Existing manufacturer data
- Data from equivalent devices
- Data from curated
databases/registries/reference databases
- Data from outside the EU with
justification on applicability
Published experience gained by routine
diagnostic testing - REAL-WORLD PERFORMANCE DATA
- Data obtained from PMPF/ PMCF
a) MDSW intended to analyse sleep quality data
An independent MDSW intended to take into account accelerometer and microphone data to determine
quality of sleep and to estimate the expected success rate of CPAP (continuous positive airway pressure)
treatment for sleep apnoea.
The Manufacturer claims that the MDSW
- determines the quality of sleep that impacts the general well-being.
- monitors quality of sleep in patients with sleep disorders such as sleep apnoea (using phone
sensors/wearable devices)
- estimates the expected success rate of CPAP therapy.
Valid Clinical Association
To establish VALID CLINICAL ASSOCIATION , review literature.
- Objective quality of sleep is measured by sleep duration, efficiency and fragmentation. It is further
well-established that quality of sleep impacts general well-being such as concentration, risk-factors
for cardiovascular disease, mood, cognitive abilities, etc.
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- It is not well-established that the success of CPAP therapy can be predicted by monitoring the
quality of sleep.
- Address the association of accelerometer and microphone data to established quality of sleep
parameters (e.g. sleep duration, efficiency and fragmentation).
The VALID CLINICAL ASSOCIATION has been not established without gaps for prediction of success of CPAP
therapy, which requires generation of missing clinical data.
Technical Performance
- Confirm with verification and validation tests that the app can reliably and reproducibly calculate
sleep quality scoring.
- Confirm compatibility between the MDSW and the device equipped with the sensors to ensure data
can be utilised in the intended way.
Clinical Performance
- In addition to the USABILITY assessment, the manufacturer would perform a retrospective study on
previously obtained data to confirm that success of CPAP therapy can be predicted based on the
quality of sleep.
b) MDSW intended for image segmentation
An independent MDSW intended to allow automatic detection of organs and anatomical structures (such
as the aorta) in CT scans with the accuracy of a radiologist.
The Manufacturer claims that the MDSW:
- detects abdominal aortic aneurisms on abdominal CT scans,
- detects compression fractures on vertebrae,
- detects liver cysts.
Valid Clinical Association
To establish VALID CLINICAL ASSOCIATION , review literature.
- The normal shape and size of anatomy is well established.
- Segmentation techniques on cross-sectional images correlates well with the actual size and shape.
The VALID CLINICAL ASSOCIATION has been established without gaps identified.
Technical Performance
- Confirm with verification and validation tests the basic technical performance such as display,
modification, window levelling of images, measurements including confirmation of accuracy,
sensitivity and reliability of the MDSW as per the expected performance.
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Clinical Performance
- USABILITY assessment including the intended user groups in conjunction with the VALID CLINICAL
ASSOCIATION and validation of T ECHNICAL PERFORMANCE results has been determined as
sufficient to demonstrate conformity with relevant GSPRs.
- In cases where data is available, a retrospective analysis can be performed. In cases where data
does not represent the variability of input parameters, for the CLINICAL PERFORMANCE of the
segmentation algorithm, the missing data could be generated in a prospective CLINICAL
INVESTIGATION .
c) MDSW intended to detect inflammatory bowel diseases (IBD)
Self-testing independent MDSW intended for the semi-quantitative detection of calprotectin from a faecal
sample. Reagents are added to the sample resulting in a colour change. The sample is then photographed
on a smartphone, and the image is evaluated by an MDSW application (app) running on the phone. The
MDSW app detects the colour change in the sample and interprets the concentration of calprotectin. The
test is intended as an aid in monitoring and staging of patients with inflammatory bowel disease (IBD).
Manufacturer’s claims that the MDSW app
- aids in monitoring and staging the disease level of patients with inflammatory bowel diseases
(IBD).
- aids in differentiation between IBD and functional bowel disorders.
- helps patients avoid unnecessary clinical visits.
Scientific Validity
To establish S CIENTIFIC VALIDITY, review literature.
- The SCIENTIFIC VALIDITY could address how the calprotectin level corresponds to the IBD level
and stages. Furthermore, it should address, whether calprotectin levels are suitable to differentiate
between IBD and functional bowel disorders.
- It is well-established that calprotectin concentration in faecal matter can be reliably measured in
test strips by change of colour.
- The colour intensity is directly representative of the concentration of calprotectin.
Analytical Performance
- Confirm the MDSW app can detect reliably and accurately the colour of the test strip compared to
human observation, taking into account environmental factors.
Clinical Performance
- The manufacturer should assess the initial performance and feasibility by creating CLINICAL
PERFORMANCE metrics, taking into account sensitivity, specificity and confidence intervals.
- Any claims regarding CLINICAL BENEFIT should be supported by sufficient clinical performance
data.
- USABILITY should be confirmed by the manufacturer.
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d) Active devices containing MDSW to enable their intended purpose
Active devices, such as diagnostic or therapeutic devices, that include MDSW which drives the device in a
way that, without the software it would not be able to fulfil its intended purpose. This software does not
perform a medical purpose on its own.
The CLINICAL EVALUATION of the MDSW should not be performed independently but should be performed
together with the driven device.
e) MDSW which provides an additional user-interface to control an insulin pump
A MDSW intended to virtualise controls of an insulin pump additionally on a smartphone app by connecting
to it.
As the software is driving the insulin pump, it is not performing a medical purpose on its own, nor is it
creating information on its own for medical purposes.
The CLINICAL EVALUATION of the MDSW app should not be performed independently but should be
performed together with the driven insulin pump.
f) MDSW intended to analyse exhaled CO2 in a life-sustaining device in order to control
ventilator settings
The MDSW uses physiological data of the patient (e.g. exhaled CO 2, blood oxygen saturation) to control a
ventilation device (e.g. frequency, volume and pressure).
The MDSW allows the device to maintain the pre-set value at a desired target (defined by the clinician)
without periodic user adjustments needed. This MDSW is part of a closed-loop system.
The CLINICAL EVALUATION should not be limited to the MDSW and should include pre-clinical and clinical
investigations, encompassing the entire closed-loop system. |
mdcg_2019_9_sscp_en.pdf.txt | Medical Device
Medical Device Coordination Group Document MDCG 2019-9
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MDCG 2019-9
Summary of safety and clinical performance
A guide for manufacturers and notified bodies
August 2019
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.
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MDCG 2019-9
Summary of safety and clinical performance
A guide for manufacturers and notified bodies
August 2019
Table of contents
Introduction .............................................................................................................................. ...............................3
Abbreviations .............................................................................................................................. ...........................3
General requirements and recommendations for the SSCP ..........................................................................4
Validation and uploading of the SSCP ...............................................................................................................7
Guidance for each of the required sections of the SSCP document ...........................................................10
1. The identification of the device and the manufacturer, including the Basic UDI-DI and, if
already issued, the SRN .........................................................................................................................10
2. The intended purpose of the device and any indications, contraindications and target
populations .............................................................................................................................. ..................11
3. A description of the device, including a reference to previous generation(s) or variants if
such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intended to be used in combination with
the device .............................................................................................................................. ....................11
4. Information on any residual risks and any undesirable effects, warnings and precautions ......12
5. The summary of clinical evaluation as referred to in Annex XIV, and relevant information on
post-market clinical follow-up .................................................................................................................15
6. Possible diagnostic or therapeutic alternatives ...............................................................................18
7. Suggested profile and training for users ...........................................................................................19
8. Reference to any harmonised standards and CS applied .............................................................19
9. Revision history .............................................................................................................................. ......19
References .............................................................................................................................. .............................20
Appendix: Template for the SSCP ....................................................................................................................21
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Introduction
The Regulation (EU) 2017/745 on medical devices (1) requires that the
manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or
investigational devices. The SSCP shall be validated by a notified body (NB) and made available to the public via the European database on medical devices (Eudamed)
1.
The SSCP is intended to provide public access to an updated summary of clinical data
2 and other information about the safety and clinical performance of the medical
device. The SSCP will be an important source of information for intended users – both healthcare professionals and if relevant for patients. It is one of several means intended to fulfil the objectives of the Medical Device Regulation (MDR) to enhance transparency and provide adequate access to information
3.
The SSCP is not intended to:
give general advice on the diagnosis or treatment of particular medical
conditions, nor
replace the instructions for use (IFU) as the main document that will be
provided to ensure the safe use of a particular device, nor
replace the mandatory information on implant cards
4 or in any other
mandatory documents.
The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP. The word “shall” is used when there is a corresponding “shall” in the MDR, otherwise “should” or “recommended” etc. is used indicating the interpretation of the MDR.
Abbreviations
CIV ID clinical investigation identification number, generated by Eudamed for
clinical investigations under the Medical Device Directives (2) (3)
CMR carcinogenic, mutagenic or toxic to reproduction CS ‘common specifications’ as defined in the MDR
5
EU European Union Eudamed European database on medical devices FSCA field safety corrective action
6
FSN field safety notice7
1 MDR, Article 32 (1)
2 MDR, Article 32 (2)(f) , Article 61 (11) and Article 83 (3)(d)
3 MDR, Recital (43)
4 MDR, Article 18
5 MDR, Article 2 (71)
6 MDR, Article 2 (68)
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4(24) IFU instructions for use
MDR Medical Device Regulation (1) NB notified body
8
PMCF post-market clinical follow-up9
PMS post-market surveillance10
PSUR periodic safety update report11
SRN single registration number for an economic operator12
SSCP summary of safety and clinical performance TD technical documentation
13
UDI-DI Unique Device Identification - device identifier14
URL Uniform Resource Locator (internet address)
General requirements and re commendations for the SSCP
The information in the SSCP should be sourced entirely from the technical documentation (TD) of the device
15. Examples of such documents are design
verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (P MS) and post-market clinical follow-up
(PMCF) plans and reports. The IFU includes information extracted from the same sources as the SSCP, but may itself be used as a source for the SSCP if appropriate. The SSCP shall be kept updated in Eudamed
16. When the PMCF evaluation report17
and the periodic safety update report (PSUR)18 are updated at least annually19, the
SSCP shall be reviewed and updated20 if needed to ensure that any clinical and/or
safety information in the SSCP remains correct and complete. When updating the SSCP, all sections of the document shall be updated if needed so that they are in alignment with the most current version of the relevant parts of the TD of the device. This guide outlines the minimum content of the SSCP. The manufacturer may add further information from the TD of the device to enhance the comprehension of the mandatory information providing:
it does not affect the readability of the SSCP and
it excludes any element of a promotional nature.
7 MDR, Article 2(69)
8 MDR, Article 2 (42)
9 MDR, Annex XIV Part B
10 MDR, Article 2 (60)
11 MDR, Article 86 Periodic safety update report
12 MDR, Article 31(2)
13 MDR, as specified in Annexes II and III.
14 MDR, Article 2 (15) and Article 27
15 MDR, Annex II and III
16 MDR, Article 29 (4) and Annex VI Part A 2.14
17 MDR, Article 61 (11)
18 MDR, Article 86 (1)
19 MDR Article 86 (1); PSUR for class IIa devices shall be updated when necessary and at least every two years
20 MDR, Article 61 (11) and Article 83 (3)(d)
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The SSCP shall be objective and adequately summarise both favourable and
unfavourable data21.
For further guidance on the contents of the SSCP, please refer to sections 1-8 of this document and to the template in the Appendix. The format and structure of this template is recommended. It addresses all of the SSCP content requirements of the MDR
22, but the order has been revised to enhance its presentation.
The IFU shall contain all that is needed to directly find the SSCP in Eudamed. The following applies to the IFU
23.
It shall state that the SSCP is available in the European database on medical
devices (Eudamed), where it is linked to the Basic UDI-DI.
It should provide the URL to the Eudamed public website:
https://ec.europa.eu/tools/eudamed
It should state the value of the Basic UDI-DI. Alternatively, another metadata
can be stated provided it can be used to unambiguously search and find the intended SSCP in Eudamed.
Translations to other EU languages No single language will be understood by all intended users and patients in the EU – see the European Survey on Language Competences initiated by the European Commission (4). In order to meet the requirement in the MDR that the SSCP shall be written in a way that is clear to the intended user and, if relevant, to the patient
24,
the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold. This is by analogy with the requirement for an IFU
25. Note that Member States may have different language requirements for an
IFU depending on whether the information is intended for health care professionals or for patients. The SSCP part intended for patients should be provided in all the languages required for IFUs intended for patients in the Member States concerned. If the selection of European languages for the SSCP does not include English, then an English translation of the document should also be provided. English is the most common language used in medical scientific publications and is understood by many healthcare professionals in the EU. Always providing an English-language version of the SSCP further enhances access to information
26 about devices available on the
EU market. There should be one SSCP document for each language. Each SSCP document should state in which language the SSCP was validated by the NB. The manufacturer should ensure, through their quality management system, that the translations are correct.
21 MDR, Annex XIV, Part A Clinical evaluation, (2)
22 MDR, Article 32 (2)
23 MDR, Article 32 (1) and Annex I, 23.4 (d)
24 MDR, Article 32 (1) and Recital (43)
25 MDR, Annex II (2), Article 10 (11)
26 MDR, Recital (43)
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Relevant SSCP information for patients The MDR indicates that patients are also intended recipients of the information in the SSCP, “if relevant”
27. Devices for which information will be especially relevant for
patients include:
implantable devices for which patients will be given implant cards28, and
class III devices that are intended to be used directly by patients.
For these devices, a part of the SSCP specifically intended for patients should be provided. Note: Devices listed in MDR Annex XVI, and eligible for a SSCP, should always be considered as relevant for patient information. For devices other than the two groups listed above, including any devices listed in Annex XVI and eligible for a SSCP, the manufacturer may consider whether it is relevant to provide specific information intended for patients. This can be based on the manufacturer’s analysis of the device in question. Readability The SSCP should always have one part for intended users/healthcare professionals, and when it is relevant (see above) a second part for patients. Both should be clear and provide information at an appropriate depth to reflect the healthcare professionals’ and the patients’ different levels of knowledge
29.
For further guidance, see references (5) and (6) in this guide. It should not be assumed that the patient has any formal education in a medical discipline or any prior knowledge of medical terminology or clinical research. It is recommended that the readability of the part of the SSCP intended for patients is assessed for example by a test given to lay persons. The manufacturer may use a method it finds adequate for the readability test to confirm that the SSCP is written in a way that is clear to the patient
30.
Medical terminology, relevant for the medical device and the clinical context, should be used consistently throughout the part of the SSCP that is intended for healthcare professionals. Stylistic recommendations The SSCP should be presented in an organised and unambiguous manner. Usually, abbreviations and acronyms should not be used; if they are, then in the text, the abbreviation or acronym should follow the full phrase it is intended to replace. It may then be used thereafter throughout the document.
27 MDR, Article 32 (1)
28 MDR, Article 18
29 MDR, Article 32 (1) and Recital (43)
30 MDR, Article 32(1), Article 2 (38)
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7(24) Medical terms should be explained in simple language in the parts intended for
patients. Consistency should be assured by giving the lay term with a description first, and then the medical term immediately afterwards (in brackets). On a case-by-case basis the lay or medical term (but preferably the lay term) may then be used throughout the part intended for patients. It is recommended to keep the information for patients/lay persons and for intended users/healthcare professionals in two separate parts of the SSCP, separated by a “page break”. This enhances their readability and facilitates printing of each part
separately. See the template in the Appendix of this document. The SSCP should be written in a font type and size which allow easy reading. Since the SSCP is intended for the public, it needs to be in a format that everyone can read (and that is not editable) without the need for a license. Therefore the SSCP file uploaded in Eudamed should be in PDF format. When downloaded, the PDF file should be printable and searchable with t he search function in the program used to
view the file, for example the Adobe Reader.
Validation and uploading of the SSCP
Validation of the initial SSCP by the NB When the NB has assessed that all the required elements
31 are included in the draft
SSCP, accurately presented and in alignment with the most current version of
relevant documents in the TD, the SSCP has been validated by the NB.
In the circumstance that the conformity assessment is performed according to Annex X and XI in the MDR and there are two NBs involved, it is the NB which assesses the TD according to Annex X that shall validate the SSCP. The validation of the SSCP by the NB covers only one of the language(s) accepted by the NB and agreed with the manufacturer. The manufacturer should state in the revision history in each SSCP document in which language the SSCP was validated by the NB. The timing of the SSCP validation may depend on the class of device and the conformity assessment routes:
For class III devices and class IIb im plantable devices, except sutures and
staples etc.
32, the validation is performed when a draft SSCP as a part of the
application documents is submitted to the NB involved in the conformity assessment
33, prior to issuing the certificate.
For class IIa implantable and some IIb implantable devices such as sutures
and staples etc34, a draft SSCP as a part of the application documents shall
be submitted to the NB involved in the conformity assessment. The draft
31 MDR, Article 32 (2), Article 61 (11), and Article 83 (3) (d)
32 MDR, Article 52 (4) 2nd paragraph
33 MDR, Article 32 (1)
34 MDR, Article 52 (4) 2nd paragraph
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8(24) SSCP shall be validated by the NB35.
In the circumstance if more than one device is covered by the relevant certificate, at least one draft SSCP shall be validated against relevant documents in the TD during the initial conformity assessment, prior to issuing the certificate. Draft SSCPs that are not validated at the initial conformity assessment, shall be validated against relevant documents in the TD at least once during the period of validity of the certificate.
Validation of updates of the SSCP between certifica tion activities
The manufacturer has an obligation to keep the SSCP updated; for further details see the section “General requirements and recommendations for the SSCP” in this guide. Furthermore the manufacturer shall prepare a periodic safety update report (PSUR) that includes data gathered as a result of the post-market surveillance plan, description of any preventive and corrective actions taken, conclusions of the benefit-risk determination, and the main findings of the PMCF
36.
If the PSUR contains information rendering any information in the SSCP incorrect or incomplete, the SSCP shall be updated
37 to be in line with the information in the
most recent PSUR. The manufacturer shall submit a PSUR to the NB at least annually, or for class IIa implantable devices
38 at least every two years39.
If the SSCP has been updated with new/changed information, except for strictly editorial modifications, the manufacturer should submit the updated SSCP to the NB when submitting the required PSUR.
If the SSCP has been previously validated, the NB should validate the updated
SSCP against the submitted and evaluated PSUR. Both the NB and the
manufacturer should make an effort to keep the validation time short in order to meet the MDR requirement of an update of the SSCP at least annually if indicated
40.
If the SSCP has not previously been validated41, the NB may defer the
validation until a validation against the relevant documents in the TD is planned during the period of validity of the certificate.
In addition, as part of its surveillance activities, the NB shall verify that the manufacturer has appropriately updated the SSCP. The NB should take into consideration its assessment of the PMS plan and PSUR, the PMCF plan and its evaluation report, and/or other relevant information.
35 MDR, Article 32 (1)
36 MDR, Article 86 (1)
37 MDR, Article 29 (4) and Annex VI Part A 2.14, and Article 61 (11) and Article 83 (3)(d)
38 In this context applicable for implantable devices intend ed to be placed in the teeth, MDR Annex VIII, 5.4. Rule
8)
39 MDR, Article 86 (1)
40 MDR, Article 61 (11)
41 May only be applicable for class IIa implantable devices and some IIb implantable devices such as sutures,
staples etc. as listed in MDR, Article 52 (4) 2nd paragraph
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Validation of SSCP at certificate renewal With each certificate renewal application, the manufacturer should:
For class III devices and class IIb impl antable devices, other than sutures and
staples etc.
42, submit a draft SSCP which has been updated within the previous
12 months, regardless of whether there are new data or conclusions.
For class IIa implantable and IIb implantable devices, such as sutures and
staples etc.43, confirm that the SSCP in Eudamed is in alignment with the
current version of the TD, or provide an updated SSCP where required.
At certificate renewal, the same principles should apply for the validation of the SSCP documents as at the initial certification. Uploading of the SSCP in Eudamed The SSCP shall be uploaded in Eudamed by the NB
44, which is the only actor that
can manage the SSCPs in Eudamed. Timelines for uploading of the SSCP documents in Eudamed:
The NB shall upload the SSCP validated in conjunction with an initial
conformity assessment at the same time that it uploads the issued certificate.
For class IIa implantable and IIb implantable devices, such as sutures and
staples etc.
45, the NB shall upload the SSCPs of all the devices covered by
the issued certificate at the same time that it uploads the issued certificate, even if some of the SSCPs have not been validated yet, and are to be validated during the period of validity of the certificate. The manufacturer should state in a revision history in the SSCP document whether that revision was validated by the NB. It is important and should be transparent to the public
46 whether the SSCP document has been validated
yet by the NB. See the example of a revision history in section 9 and in the template in the Appendix of this guide.
The NB shall upload a SSCP whenever it has been validated against relevant
documents in the TD, and thus replacing the SSCP uploaded at the initial
certification with the currently validated revision.
The manufacturer is responsible for the translations of the SSCP into other
languages
47, once the “master” SSCP has been uploaded by the NB.
If the “master” SSCP is in a language other than English, then an English translation should be provided by the manufacturer within 90 days of the upload of the “master” SSCP. The NB should upload the English translation within 15 days of receiving this from the manufacturer.
The manufacturer decides when it translates the initial “master” SSCP into
other languages in the Member States depending on when/if they plan to place the product on that market.
42 MDR, Article 52 (4) 2nd paragraph
43 MDR, Article 52 (4) 2nd paragraph
44 MDR, Article 32 (1)
45 MDR, Article 52 (4) 2nd paragraph
46 MDR, Recital (43)
47 See page 4 in this guide, Translations to other EU languages; The manufacturer should ensure, through their
quality management system, that the translations are correct.
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10(24) The NB does not validate the translated SSCP documents. It should upload
them in Eudamed within 15 days of receiving them.
The manufacturer shall verify that the SSCP, and any translations needed for any single Member State, have been uploaded in Eudamed before placing a device on that market
48.
When receiving an updated SSCP document in conjunction with the PSUR,
the NB should upload the updated SSCP document within 15 days after it is validated, or within 15 days after deeming the validation to be deferred
49 until
a validation against the relevant documents in the TD is planned during the period of validity of the certificate.
At certificate renewal, the NB shall upload any updated SSCPs of all the
devices covered by the reissued certificate at the same time that it uploads
the reissued certificate. The NB should ensure the revision history indicates whether or not these have been validated by the NB.
The manufacturer should provide updated translations to the NB within 90
days of the upload of the updated “master” SSCP. The NB should upload these translations within 15 days of receiving them from the manufacturer.
Guidance for each of the required sections of the SSCP document
1. The identification of the device and the manufacturer, including the Basic
UDI-DI and, if already issued, the SRN
The first section of the SSCP shall ident ify the device and the manufacturer, and
should also contain some general information related to the device:
1.1. Device trade name(s) (this include all trade names the device may have on
the market in different Member States)
1.2. Manufacturer’s name and address 1.3. Manufacturer’s SRN (single registration number) 1.4. Basic UDI-DI 1.5. Medical device nomenclature
50 description / text
1.6. Class of device51
1.7. Year when the first certificate (CE) was issued covering the device 1.8. Authorised representative if applicable; name and the SRN 1.9. NB’s name (the NB that will va lidate the SSCP) and the NB’s single
identification number
52
48 MDR, Article 29 (4) and Section 2 of Part A of Annex VI (2.14)
49 May only be applicable for class IIa implantable devices and some IIb implantable devices as listed in MDR,
Article 52 (4) 2nd paragraph
50 MDR, Article 26
51 MDR, Annex VIII
52 MDR, Article 43 (1)
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11(24) 2. The intended purpose of the device and any indications, contraindications
and target populations
2.1. The device's intended purpose(s) shall be described.
2.2. The indications shall be described. This includes the stages and/or severities
of the pathologies, the specific medical conditions, and the specific anatomical locations or confirmation that no anatomical locations are contraindicated, as applicable. The target population(s) shall be specified, for example if the device is intended for adults and/or children and/or infants/neonates.
2.3. Any contraindications or restrictions for use or limitations of the device shall
be included.
The information can be sourced from the IFU, or from the clinical evaluation report.
3. A description of the device, including a reference to previous generation(s)
or variants if such exist, and a description of the differences, as well as, where relevant, a description of any accessories, other devices and products, which are intende d to be used in comb ination with the device
3.1. A description of the device shall be presented, including its operating
principles and mode(s) of action. Design characteristics should be included, for example key functional elements and any materials or substances in contact with the patient’s tissues. Include information on whether the device is for single use, and its method of sterilisation. For absorbable implants the
stability retention profile, including time to loss of stability and the absorption
time, should be provided. A picture or drawing can be added accompanied by text.
Information about the constituents should be provided, as required for the IFU
53, if the device incorporates
a medicinal substance (including a human blood or plasma derivative), or
tissue(s) or cells of human or animal origin, or their derivatives, or
substances or combinations of subs tances that are absorbed by or locally
dispersed in the human body, or
materials incorporated into the device that contain or consist of CMR
(carcinogenic, mutagenic or toxic to reproduction) substances or
endocrine-disrupting substances, or
materials that could result in sensitisation or an allergic reaction by the
patient or user.
In Eudamed, the SSCP is associated to one unique Basic UDI-DI. All UDI-DIs/devices associated to this Basic UDI-DI will be seen as having the same
53 MDR, Annex I (23.2) (e) and (r), and (23.4) (s)
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12(24) SSCP (a UDI-DI/device must always be associated with one and only one
Basic UDI-DI). If the device is a system of several components/devices, each device in the system should have a Basic UDI-DI but also one Basic UDI-DI for the system. It is the Basic UDI-DI for the system that is intended to be provided in section 1.4 in the template, and that will be associated with the SSCP in Eudamed. The device system, and any Basic UDI-DIs of included devices, should be described in section 3.1. The device description in the SSCP shall therefore include all the device(s)/device system associated with the same Basic UDI-DI. The
description of the device(s)/device system should be comprehensive and can be presented in different ways to include, if such exist, any configurations / combinations / different sizes / specification of any soft-ware versions that can be related to safety and/or performance and their release dates / etc. The description should also include any model number or similar designation used to identify the device(s)/device system.
3.2. A reference to previous generation(s) or variants shall be provided, if such
exist. This applies both to changes/variants of the device itself (same Basic UDI-DI) and to previous generation(s) or variants associated with other Basic UDI-DIs, if available. A description of the differences shall be provided, highlighting the reasons for the change; for example changes to the intended clinical benefits, changes to reduce iden tified clinical risks, or changes for
manufacturing reasons etc.
3.3. If there are any accessories
54 that are not themselves devices, but are
intended by the manufacturer to be used in combination with the device, they shall be described or listed. The list of accessories should include all those that are essential for the safe and correct use of the device.
3.4. If there are any other devices and products intended to be used in
combination with the device, they shall be described or listed. However, generic surgical equipment and/or other generic devices do not need to be listed.
In the part of the SSCP that is intended for patients, section 3 may be limited to the device(s) in question (Basic UDI-DI) including relevant and necessary accessories from a patient’s perspective; see suggested headings for section 3 in the template in the Appendix.
4. Information on any residual risks and any undesirable effects, warnings
and precautions
54 MDR, Article 2 (2)
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13(24) 4.1. Residual risks and undesirable effects
This section of the SSCP guide and template includes residual risks
55, other
than those contraindications, limitations, warnings and precautions that are included in sections 2.3 and 4.2. Description of residual risks and undesirable effects Risk is defined in the MDR
56 as the combination of the probability of
occurrence of harm and the severity of that harm. Harm is defined in the standard ISO 14971:2012
57 as physical injury or damage to the health of
people, or damage to property or the environment. Thus the term ‘risk’ includes both clinical and non-clinical harms. The term ‘residual risk’ is defined in the standard ISO 14971:2012
58 as “risk
remaining after risk control measures have been taken”.
There is a requirement in the MDR that the IFU shall contain information on
any residual risks and any undesirable side-effects
59, i.e. no sort of residual
risk or undesirable side-effect related to the device is excluded from
disclosure. The SSCP should contain information on at least the same residual risks and undesirable side-e ffects as included in the IFU.
For the purpose of the SSCP, an undesirable effect
60 can be understood as
any undesirable side-effect related to the device and that is experienced by the patient and/or can be diagnosed and/or measured in the patient.
For the clarity of the SSCP, undesirable side-effects can be annotated also in other terms as appropriate, to present any undesirable side-effects related to the device in question. There may be device-specific terminology for describing side-effects and risks in device -specific ISO standards or scientific
literature that is important to use to allow comparison of clinical data. For example, some events indicated in the MDR by the terms ‘adverse events’
61, ‘undesirable side-effects’ or ‘incidents’62, may all be annotated as
‘adverse events’ in the scientific literature. Any further discussion on risks can be included in the SSCP if needed for clarity or comprehension.
Quantitative data The definition of risk
63 includes the probability of occurrence of harm.
Therefore the information in the SSCP on risks shall also include
55 MDR, Annex I, (23.1) (g)
56 MDR, Article 2 (23)
57 EN ISO 14971:2012 Medical devices – Application of risk management to medical devices, section 2.2
58 EN ISO 14971:2012 Medical devices – Application of risk management to medical devices, section 2.15
59 MDR, Annex I , 23.4 (g)
60 MDR, Article 32 (2) (h)
61 MDR, Article 2 (57)
62 MDR, Article 2 (64)
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14(24) quantifications. This information can be sourced from the clinical evaluation
report where an updated examination of qualitative and quantitative aspects of clinical safety is available, with clear reference to the determination of residual risks and side-effects
64.
It should also be clarified in the SSCP whether quantitative data on side-effects or residual risks rela te to clinical data that were obtained proactively,
for example from a structured prospective follow-up study of the device itself, or if the expected frequencies
65 come from a systematic review of the
scientific literature. It should be disclosed in the SSCP if data from spontaneously reported incidents or serious incidents
66 are used as one of
the sources for estimating quantitative data on side-effects or residual risks, in which case significant under-reporting needs to be considered. A relation to time should also be included when presenting the quantitative data, for example during five or ten years of use from implantation, or adverse events per 100 patient-years for implantable devices with constant hazards, etc. The quantitative data and the relation to time should always be presented together.
To use tabulated lists for the presentation of side-effects and residual risks with quantitative data and a relation to time, may enhance the readability. In the part of the SSCP that is intended for patients, residual risks and side-effects should be explained and quantified in a way that patients and lay persons can understand. A statement should be included about how potential risks have been controlled or managed, and also a statement on what to do if the patient believes that he/she is experiencing side-effects related to the device or its use. See the example in the template in the Appendix.
4.2. All warnings and precautions pertaining to the device should be presented.
However warnings and precautions solely related to for example installation/preparation of a device or relating to special procedural steps can be discussed on a general level in the SSCP if a link (URL) to the IFU on the manufacturer’s website is provided. Always include any warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions. If any particular clinical follow-up is necessary and mentioned in the IFU, that information should also be included in the SSCP.
63 MDR, Article 2 (23)
64 MDR, Annex XIV, Part A Clinical evaluation, (1)
65 MDR, Article 88 (1)
66 MDR, Article 2 (64) and (65)
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15(24) 4.3. Other relevant aspects of safety s hould be described. If the device has been
subject to any field safety corrective action (FSCA including FSN), the date of the FSCA and a summary of the associated circumstances and any actions undertaken should also be included.
5. The summary of clinical evaluation as referred to in Annex XIV, and relevant
information on post-market clinical follow-up
This part of section 5 relates to content intended for the user/healthcare professional. This section is intended to summarise, in a comprehensive manner, the clinical evaluation results and the clinical data
67 forming the clinical evidence68 for the
confirmation of conformity with relevant general safety and performance requirements
69, the evaluation of undesirable si de-effects and the acceptability of
the benefit-risk ratio70.
It shall be an objective and balanced summary of the clinical evaluation
71 results
of all the available clinical data related to the device in question, whether favourable, unfavourable, and/or inconclusive. See suggested headings for this section in the Appendix of this document.
5.1. The SSCP should include a statement if conformity of the device was
assessed and endorsed by the NB on the basis of equivalence. If equivalence was used, t hen the device(s) for whic h equivalenc e has been
demonstrated should be identified by name and Basic UDI-DI if available, together with the name(s) of its/their manufacturer(s).
The SSCP should also include a statement whether the equivalent device’s SSCP is available in Eudamed. If not available in Eudamed, the SSCP should include a summary of the clinical data pertaining to the equivalent device, written in accordance with the recommendations of this section 5, with a clear note that it relates to the equivalent device. It should be evident from the summary what the clinical evidence for the equivalent device was based on: whether it was clinical investigations of that device itself, or if any other data were used and then the sources of that data. Also include a summary of how long-term safety and performance of the equivalent device has been confirmed.
5.2. All clinical investigations of the device in question, conducted before the CE-
marking, should be summarised. It is recommended to keep the format clear
67 MDR, Article 61 (11) and Article 2 (48)
68 MDR, Article 2 (51)
69 MDR, Annex I
70 MDR, Article 61 (1) and Annex XIV, Part A (1)
71 MDR, Annex XIV, Part A (2)
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16(24) by grouping the information for each study. The summary of each
investigation should include the following non-exclusive list:
Identity of the investigation/study: If performed under the Medical Device
Directives or the MDR, then give the CIV ID or single identification number. Add reference details if the clinical investigation report is available in Eudamed
72. For other studies, the title of the study and a clear
reference to a clinical trials database or publication where detailed data on the study can be found (7)
73 should be included. In the circumstance that
the investigation/study was conducted outside EU, identify the country/-ies where it was performed.
Identity of the device including any model number/version
Intended use of the device in the investigation
Objectives of the study
Study design: randomised controlled trial, other pivotal trial, short-term
feasibility study, other; and the duration of the follow-up
Primary and secondary endpoint(s)
Inclusion/exclusion criteria for subject selection
Number of enrolled subjects, including if applicable in different treatment
arms
Study population: main baseline characteristics of each study group,
including gender and age of enrolled subjects
Summary of study methods
Summary of results: any clinical benefits
74; any undesirable side-effects or
adverse events, and their frequency in relation to time; any results on long-term benefits or risks, for exampl e implant survival rates at 5 or 10
years and/or cumulative experience in patient-years. A statement of percentage completeness of follow-up should be provided. Add a note if the study is still ongoing for long-term follow up.
Any limitations of the study, such as high loss to follow-up, or potential
confounding factors that may question the results.
Any device deficiency and any device replacements related to safety
and/or performance during the study.
5.3. Summary of other clinical data and the main findings pertaining to the device
itself should be included if available. This can be sourced
75 for example from:
A systematic literature review yielding articles in which the device in
question was used. References to these articles should be provided. A bibliography can be added at the end of the SSCP document if there are many references.
Clinically relevant information based on clinical data obtained from the
implementation of the manufacturer’s PMCF and PMS plans, such as:
72 MDR, Article 77 (7)
73 WMA Declaration of Helsinki, sections 35, 36, MDR Recital (64)
74 MDR, Article 2 (53)
75 MDR, Article 2 (48)
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17(24) - Conducted PMCF investigation(s)76; include information on each study
as outlined in section 5.2 in this guide.
- New or changed likelihood of an undesirable side-effect(s), or
significant increase in the frequency or severity of incidents, or any
identified trends77, or any other main findings from the PMCF
evaluation report or PSUR78.
Analysis of clinical data from medical device registries. Any known
limitations such as incomplete follow-up should be disclosed.
5.4. An overall summary of the clinical performance79 and safety should be
provided, and that is supported by clinical evidence80, based on clinical data
and the clinical evaluation results pertaining to the device in question. It is recommended that the overall summary should include the following:
The clinical performance normally leads to clinical benefits for the patient.
Give a description of the documented clinical benefits
81 for patients with
relevant and specified clinical outcome measures, and the success rate for achieving the outcome measures. This should be described for all clinical claims the manufacturer presents in the IFU, and in any information, marketing, or promotional material that it distributes. For a non-absorbable implant, there should also be information about the expected lifetime of the device including data on implant survival rates.
Benefit-risk assessment for the various indications including the
acceptability of the benefit-risk ratio
82. This includes a summary of the
evaluation of undesirable side-effects.
In the case of a device without an intended medical purpose
83, the
requirement to demonstrate clinical benefit shall be understood as a requirement to demonstrate the performance of the device. The summary of the clinical evaluation shall be based on relevant data concerning safety and performance
84.
5.5. The SSCP shall have a section on planned or ongoing PMCF85 that should
include the following (non-exclusive list):
Summary of the latest approved PMCF plan for the device. Include any
planned or ongoing studies (brief description), and if there are any unanswered questions relating to the use of the device and how they will be investigated.
76 MDR, Article 74 (1)
77 MDR, Article 88 (1) and Annex XIV Part B (6.1) (b)
78 MDR, Article 61 (11), Article 83 (3) (d)
79 MDR, Article 2 (52)
80 MDR, Article 61 (1) and Article 2 (51)
81 MDR, Article 2 (53)
82 MDR, Article 61 (1) and Annex I Sections 1 and 8
83 MDR, Annex XVI
84 MDR, Article 61 (9)
85 MDR, Annex XIV Part B
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18(24) If any emerging risks, complicati ons or unexpected device failures have
been detected, and how these will be followed up.
The information on clinical evaluation and PMCF intended for patients, in
section 5 The part of the SSCP intended for patients should be provided with a brief summary which enables the patient to understand the basis upon which clinical safety and perform ance has been de monstrated. The su mmary shoul d include
the following (non-exclusive list):
Clinical background of the device
A description of the relative novelty of the device: if the product has a
proven clinical track record of safety and performance, or if there are one or more novel design features.
The clinical evidence for the CE marking
A description whether clinical evidence is based on data concerning an equivalent device, on data collected during a clinical investigation of the device itself, or on a combination of the two. A short lay-summary of the clinical investigations performed on the device itself should be given, if such exist. If there are clinical investigation reports on the device itself available in Eudamed, this should be stated and identification numbers should be given
86 (CIV ID or single identification number). The summary
should not make misleading claims regarding the strength of clinical evidence, either by direct reporting or omission.
Safety
- A description of the benefit-risk a ssessments related to safety and
performance for each indication claimed by the manufacturer, including
information to address benefit-risk issues of interest to specific patient populations, if applicable.
- A description of how the manufacturer continuously collects information
on safety and performance and in particular if any clinical studies
(PMCF) are ongoing or planned. A description of the purpose of any such studies, for example to corroborate safety and performance claims based on equivalence data, or to demonstrate long-term safety.
6. Possible diagnostic or therapeutic alternatives
This part of the SSCP document should contain a review of how the device relates, in terms of benefit-risk, to diagnostic or therapeutic alternatives and the specific conditions under which the device and its alternatives can be considered
87.
86 MDR, Article 77 (7)
87 MDR, Recital 49
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19(24) If reference is made to the “state of the art”, that statement should be supported
for example by referring to relevant recognised guidance documents generated by specialty medical societies or educational bodies. In the part of the SSCP intended for patients the text should include a recommendation to discuss any possible diagnostic or therapeutic alternatives with a healthcare professional who can take into consideration the individual patient’s situation. See the proposed text in the template in the Appendix.
7. Suggested profile and training for users
The experience, education and/or training of the intended user(s) shall be described
88. This includes any specific mandatory training before using the
device, and any update training for continued safe use of the device. If the device is intended to be handled directly by the patient, section 7 should be included in the SSCP part intended for patients and any required training should be described.
8. Reference to any harmonised standards and CS applied
A list with all applied common specifications (CS), international standards harmonised under the Medical Device Directives (2)(3) and/or the MDR, and relevant adopted monographs of the European Pharmacopoeia
89 shall be
provided. The year/revision of the applied CS, standard or monograph, should be listed together with information whether it was applied in full or in part. The year/revision of an applied harmonised standard or CS may change in the technical documentation for the device. However, an update of the SSCP concerning this change can wait until the next revision of the SSCP is issued. This list in section 8 does not need to be included in the part of the SSCP that is intended for patients.
9. Revision history
The SSCP document should include a revision history. The purpose is to include the following information:
The SSCP revision number
Date when the revision was issued
88 By analogy with the IFU, see MDR, Annex I, 23.1 (a)
89 MDR, Article 8 (2)
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20(24) Description of the main changes
In which language the SSCP was validated by the NB
In case of a SSCP on class IIa implantable or some90 IIb implantable
devices; whether the SSCP revision has been validated yet or not by the NB
See an example of a table for a Revision history in the Appendix of this guide.
References
1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April
2017 on medical devices http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L:2017:117:TOC
2. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01993L0042-20071011
3. Council Directive of 20 June 1990 on the approximation of the laws of the Member
States relating to active implantable medical devices (90/385/EEC) http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:01990L0385-20071011
4. The European Survey on Language Competences: measuring foreign language
student proficiency. Patrícia Costa and Patrícia Albergaria-Almeida / Procedia - Social and Behavioral Sciences 191 (2015) 2369 – 2373 https://www.sciencedirect.com/science/article/pii/S187704281502515X
5. Summaries of Clinical Trials Results for Laypersons
https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-
10/2017_01_26_summaries_of_ct_results_for_laypersons.pdf
6. Common European Framework of Reference for Languages: Learning, teaching,
assessment (CEFR) https://www.coe.int/en/web/common-european-framework-reference-
languages/home
7. WMA Declaration of Helsinki - Ethical Principles for Medical Research Involving
Human Subjects https://www.wma.net/policies-post/wma-declaration-of-helsinki-ethical-principles-
for-medical-research-involving-human-subjects/
90 MDR, Article 52 (4) 2nd paragraph
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21(24) Appendix: Template for the SSCP
Texts in italic in the template are general information texts proposed to be included in
the SSCP document.
Note that there shall always be SSCP information dedicated to users/healthcare professionals for all implantable devices and for all class III devices, other than custom-made or investigational devices. When relevant, a second part dedicated to patients/lay persons should be added. See further recommendations on relevant SSCP information for patients in this guide. Summary of safety and clinical performance
This Summary of Safety and Clinical Perform ance (SSCP) is intend ed to provide public
access to an updated summary of the main aspects of the safety and clinical performance of the device. The SSCP is not intended to replace the Instructions For Use as the main document to ensure the safe use of the device, nor is it intended to provide diagnostic or therapeutic suggestions to intended users or patients. The following information is intended for users/healthcare professionals.
If the SSCP includes a part intended for patients, the following can be added:
Following this information there is a summary intended for patients .
1. Device identification and general information
1.1. Device trade name(s) 1.2. Manufacturer’s name and address 1.3. Manufacturer’s single registration number (SRN) 1.4. Basic UDI-DI 1.5. Medical device nomenclature description / text 1.6. Class of device 1.7. Year when the first certificate (CE) was issued covering the device 1.8. Authorised representative if applicable; name and the SRN 1.9. NB’s name (the NB that will validate the SSCP) and the NB’s single
identification number
2. Intended use of the device
2.1. Intended purpose 2.2. Indication(s) and target population(s) 2.3. Contraindications and/or limitations
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22(24) 3. Device description
3.1. Description of the device 3.2. A reference to previous generation(s) or variants if such exist, and a
description of the differences
3.3. Description of any accessories which are intended to be used in combination
with the device
3.4. Description of any other devices and products which are intended to be used
in combination with the device
4. Risks and warnings
4.1. Residual risks and undesirable effects
4.2. Warnings and precautions 4.3. Other relevant aspects of safety, including a summary of any field safety
corrective action (FSCA including FSN) if applicable
5. Summary of clinical evaluation and post-market clinical follow-up (PMCF)
5.1. Summary of clinical data related to equivalent device, if applicable 5.2. Summary of clinical data from conducted investigations of the device before
the CE-marking, if applicable
5.3. Summary of clinical data from other sources, if applicable 5.4. An overall summary of the clinical performance and safety 5.5. Ongoing or planned post-market clinical follow-up
6. Possible diagnostic or therapeutic alternatives 7. Suggested profile and training for users 8. Reference to any harmonised standards and CS applied 9. Revision history
SSCP
revision
number Date
issued
Change description Revision validated by the Notified
Body
Yes
Validation language:
No (only applicable for class IIa or
some IIb implantable devices (MDR, Article 52 (4) 2
nd paragraph) for which
the SSCP is not yet validated by the NB)
Yes
Validation language:
No
If the SSCP concerns a device for which it is relevant to provide information to patients in lay man’s language, the following text can be included and then followed by a “page break”:
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23(24) A summary of the safety and clinical performance of the device, intended for patients,
is given below.
Summary of safety and clinical performance Document revision: Date issued:
This Summary of Safety and Clinical Perform ance (SSCP) is intend ed to provide public
access to an updated summary of the main aspects of the safety and clinical performance of the device. The information presented below is intended for patients or lay persons. A more extensive summary of its safety and clinical performance prepared for healthcare professionals is found in the first part of this document. The SSCP is not intended to give general advice on the treatment of a medical condition. Please contact your healthcare professional in case you have questions about your medical condition or about the us e of the device in your situation. This
SSCP is not intended to replace an Implant card or the Instructions For Use to provide information on the safe use of the device.
1. Device identification and general information
o Device trade name
o Manufacturer; name and address
o Basic UDI-DI
o Year when the device was first CE-marked
2. Intended use of the device
o Intended purpose
o Indications and intended patient groups
o Contraindications
3. Device description
o Device description and material/substances in contact with patient tissues
o Information about medicinal substances in the device, if any
o Description of how the device is achieving its intended mode of action
o Description of accessories, if any
4. Risks and warnings
Contact your healthcare professional if you believe that you are experiencing side-
effects related to the device or its use or if you are concerned about risks. This
document is not intended to replace a consultation with your healthcare professional if needed.
o How potential risks have been controlled or managed
o Remaining risks and undesirable effects
o Warnings and precautions
o Summary of any field safety corrective action, (FSCA including FSN) if
applicable
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24(24) 5. Summary of clinical evaluation and post-market clinical follow-up
o Clinical background of the device
o The clinical evidence for the CE-marking
o Safety
6. Possible diagnostic or therapeutic alternatives
When considering alternative treatments, it is recommended to contact your
healthcare professional who can take into account your individual situation.
o General description of therapeutic alternatives
7. Suggested training for users |