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CLINICAL EVALUATION PLAN

[Manufacturer Name]

[Manufacturer Address]

[Product Name]

XX/XX/2023
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CONTENTS PAGE
1.Manufacturer Details…………………………………………………………………………………..2

2.Approval and Signatures………………………………………………………………………………2

3.Revision History………………………………………………………………………………………2

4.Background……………………………………………………………………………………………4
5. Scope of the Clinical Evaluation……………………………………………………………………4-5
6. Clinical Background and State of the Art……………………………………………………………..6
7. Clinical Evaluation Context and Clinical Data Types………………………………………….....6-12
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1.Manufacturer Details
PRODUCT NAME
MANUFACTURER NAME
MANUFACTURER ADDRESS
MANUFACTURER SRN NUMBER
BASIC UDI-DI NUMBER

2.Approval and Signatures

PREPEARED EXAMINED APPROVAL
DATE AND SIGNATURE DATE AND SIGNATURE DATE AND SIGNATURE

3.Revision History
REVISION NO REVISION EXPLANATION
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4.Background

This document presents a Clinical Evaluation Plan for [subject device] manufactured by [manufacturer name and
address]. The plan outlined in this document will be followed during the conduct of Clinical Evaluation activities
in relation to the device.

To meet requirements for a conformity assessment under the Medical Device Regulation (EU) 2017/745 (MDR),
a manufacturer must conduct a clinical evaluation. This must be conducted following MDR Article 61, which
requires a medical device manufacturer to demonstrate that there is clinical data to support the safety and
performance of the device. Additionally, Article 61 requires that any claims made in relation to the device’s safety
and performance under normal conditions of use are shown in evidence to be achieved. It is also a requirement
that an evaluation of undesirable side-effects and acceptability of the benefit-risk ratio referred to in Sections 1
and 8 of MDR Annex I shall be based on clinical data providing clinical evidence meeting a test on sufficiency,
including where applicable, relevant data as referred to in MDR Annex III.

MDR Article 61, Section 3(a) stipulates that clinical evaluation shall follow a defined, methodologically sound
procedure based on a critical evaluation of available, relevant scientific literature related to the safety, performance,
design characteristics, and intended purpose of the device, and that the data demonstrate compliance with
applicable MDR Annex I General Safety and Performance Requirements (GSPRs). It calls for a critical evaluation
of all available clinical investigation results, taking into consideration MDR requirements and adopted acts, and
consideration of all relevant currently available treatment options for the same purpose.

The clinical evaluation process outlined by this Clinical Evaluation Plan (CEP) details the steps taken by
[Manufacturer name] to define the device (including intended use), the scope of the Clinical Evaluation, and other
stages involved in the clinical evaluation such as the identification, appraisal and analysis of clinical data, including
Post-Market Surveillance (PMS) data. This clinical evaluation process occurs and will be updated throughout the
product life cycle.

The objective of this CEP is to document a method for conducting the ongoing clinical evaluation process for
[subject device] to demonstrate device conformity with Article 61 and Annex XIV, Part A of the MDR. It defines
the methodological and systematic approach to proceed and reach a conclusion on the clinical evaluation process
and document it in the Clinical Evaluation Report (CER) of [subject device].

This clinical evaluation plan, [document name and number] is created under the European Union (EU) Medical
Device Regulation 2017 / 745 (MDR) Article 61 and Annex XIV Part A, MDCG 2020-6: Clinical evidence needed
for medical devices previously CE marked under Directives 93/42/EEC and 90/385/EEC and (as still relevant)
MEDDEV 2.7.1 Rev 4, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives
93/42/EEC and 90/385/EEC.
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5. Scope of the Clinical Evaluation

Device Name, Reference/Model
Number
Risk Classification

Device Group

Developing/ Undergoing Initial CE Marking

Device’s Current Statatus
CE-marked

(whether the device is currently on the market in Europe or in other

Device’s Market History
countries, since when, number of devices placed on the market)
(exact medical indications (if applicable) - name of disease or
condition/ clinical form, stage, severity/ symptoms or aspects to be
Intended Purpose
treated, managed or diagnosed - patient populations (adults /
children / infants, other aspects)
Intended User and Target Groups (use by health care professional / lay person)

Duration of Use

Contraindication

Precautions
(a concise physical and chemical description - the technical
specifications, mechanical characteristics - sterility – radioactivity

- how the device achieves its intended purpose - principles of

operation - materials used in the device with focus on materials
General Description of The Device
coming in contact (directly or indirectly) with the patient/ user,
description of body parts concerned - whether it incorporates a
medicinal substance (already on the market or new), animal
tissues, or blood components, the purpose of the component - other
aspects)
Product Composition and Features
(whether the device is intended to cover medical needs that are
Device’s Intended to Cover Medıcal otherwise unmet/ if there are medical alternatives to the device / if
Needs the device is equivalent to an existing device, with a description of
the situation and any new features)
(including the technical performance of the device intended by the
manufacturer, the intended clinical benefits, claims regarding
Intended Performance/ Intended Use
clinical performance and clinical safety that the manufacturer
intends to use)
Devıce Claims / Preclinal Data
(Name, models, sizes of the predecessor device, whether the
Predecessor Devices predecessor device is still on the market, description of the
modifications, date of the modifications)
Current Label, IFU or Promotional (See. Annex X or Label folder&IFU folder……)
Materials
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6. Clinical Background and State of the Art

Identification of Medical Fields

State of the Art from the Literature

Applicable Standards

Clinical Variations, Demographics,

and Genetic Influences
Advantages, Disadvantages, and
Risk Profiles in Diverse Clinical
Scenarios
Risk Analysis and Mitigation in
Device Evaluation
User Types, Professional Opinions,
and Unmet Needs

7. Clinical Evaluation Context and Clinical Data Types

The type of assessment will be determined through the table below:

Please select

Scientific literature currently available

Identification for Evaluation Type Clinical investigations made
Combination with clinical investigation
data and literature data
……….

The demonstration of equivalence will be assessed in the clinical

evaluation report through the tables below:

Technical Equivalence:

Equivalence Table
For The Comparison Of A Device With A Presumed Equivalent
Marketed Device For The Purpose Of Demonstrating Equivalence
1. Technical Equivalent
Main Device
characteristics Device 1 Comments
Manufacturer
Demonstration of Equivalence Classification
Device is of
similar design
Used under
similar
conditions of use
Method of
Harvesting/
Decanting
Similar
specifications
and properties
including
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physiochemical
properties such
as intensity of
energy, tensile
strength,
viscosity, surface
characteristics,
wavelength and
software
algorithms
Uses similar
deployment
methods where
relevant
Sterilization
Method
Has similar
principles of
operation and
critical
performance
requirements
Usage
Anticoagulant
Scientific justification why there would be no Clinically
clinically significant difference in the safety and significant
clinical performance of the device, OR a description difference
of the impact on safety and or clinical performance Yes / No
1.1
1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
1.10

Biological Equivalence:

2. Biological
Main Device Equivalent Device Comment
characteristics
Uses the same
materials or
substances in
contact with the
same human
tissues or body
fluids

Similar kind
and duration of
contact with the
same human
tissues or body
fluids
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Scientific justification why there would be no

Clinically
clinically significant difference in the safety and
significant
clinical performance of the device, OR a
difference
description of the impact on safety and or clinical
Yes / No
performance
2.1
2.2

Clinical Equivalence:

3. Clinical Equivalent
Main Device Comment
characteristics Device 1
Same clinical
condition or
purpose,
including similar
severity and
stage of disease
Same site in the
body
Similar
population,
including as
regards age,
anatomy and
physiology
Same kind of
user
Similar relevant
critical
performance in
view of the
expected clinical
effect for a
specific intended
purpose
Scientific justification why there would be no
Clinically
clinically significant difference in the safety and
significant
clinical performance of the device, OR a
difference
description of the impact on safety and or clinical
Yes / No
performance)
3.1
3.2
3.3
3.4
3.5
Summary
The data sources from which the manufacturer will collect
information before and after the market will be determined through
the table below:
Please select

All pre market clinical investigations

Clinical Data Generated And Held PMCF studies
by The Manufacturer
Device registries
PMS reports, including vigilance reports and trend
reports
The literature search and evaluation reports for PMS
Incident reports
Complaints
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Analysis of explanted devices

Field safety corrective actions informations
Use as a custom made device
Use under compassionate use/ humanitarian
exemption programs
Other user report
According to Medical Device Regulation Annex XIV, Part A, Section
1 (a) indents 5, 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. 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.
According to relevant guide search method from literature will be
executed accordingly for clinical evaluation report.

Firstly, literature research methodology will be indicated through

the table below:

Period of Search
Data Searcher
Period Covered by Search
Literature Search Methodology Data Source
Data Search Index
Applicable Area
Data Exclusions
Criteria & Basis Data Selection

The number of literatures obtained as a result of the literature search

will be indicated in the table below:

Data Source 1 Data Source 2

Search Term 1:

Search Term 2:

Search Term 3:
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The literature searching protocol will be specified as follows:

...... potentially relevant

literature which are obtained
through the literature search • .... literatures have been eliminated
with predetermined keywords according to; .........
have been found

..... Remaining sources are

assessed for their contributions • ..... literatures have been
to the evaluation in terms of eliminated according to;
PHASE 1 their performance and safety ......
endpoints along with the study
content and methods

..... sources at the end are

classified in terms of their
performance and safety
contributions with equivalence
PHASE 2 or similarity analyses

Final selected articles are obtain for annually clinical evaluation

with respect to planned literature searching protocol.

Summary and Appraisal of Clinical In accordance with the literature review protocol, the selected final
Data literatures will be reviewed through the Clinical Evaluation Report.

According to MDCG 2020-6: Clinical evidence needed for medical

devices previously CE marked under Directives 93/42/EEC or
90/385/EEC, an analysis will be conduct with respect to the GSPRs
of the MDR, to determine if additional data to support the clinical
General Safety and Performance
evidence are required to meet additional MDR requirements.
Requirements
Annually a gap analysis will be made with respect to new MDR
requirements to obtain adequate clinical evidence and prepeare
clinical evaluation report accordingly.

Analysis of the Clinical Data

The labels, IFU and risk management document will be reviewed to

Requirement on Safety ensure they are consistent with the relevant clinical data and that all
(MDR GSPR1) the hazards, information on risk mitigation and other clinically
relevant information have been identified.
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According to MEDDEV 2.7/1 rev. 4 Appendix A7.2 b and MEDDEV

2.7/1 rev. 4 Appendix A7.2 Section c, a detailed description of
intended clinical benefits to patients with relevant and specified
clinical outcome parameters will be determined with respect to
already marketed device’s data.

Moreover, accetable benefit/risks will be examined according to

Requirement on Acceptable below criteria:
benefit/risk Profile
(MDR, GSPR1) - Positive impact on clinical outcome

- The patient's quality of life

- Statistical approach for provided clinical data

- The duration of the benefit

Product performance will be evaluated according to:

- The devices achieve their intended performances during normal

Requirement on Performance conditions of use by the content of the studies on similar
(MDR, GSPR3) product

- The intended performances are supported by sufficient clinical

evidence
Acceptability of side effects will be examined according to already
marketed product data with below criteria:

- Evaluation of the nature, severity and frequency of potential

undesirable side-effect that was observed before

- Clinical investigations or PMS that contain adequate number of

Requirement on Acceptability of observation will be examined to guarantee the scientific
Side-Effects (MDR, GSPR6) validity of the conclusions relating to undesirable side-effects
and the performance of the device

- The state of the art will be examined to guarantee acceptability

of side-effects including properties of benchmark devices and
medical alternatives and reference to objective performance
criteria from applicable standards or guidance document.

A Comprehensive Evaluation of Essential Requirements,

Benefit/Risk Profile, Information Materials, Device Suitability, and
Conclusion Consistency in Clinical Data with Addressing Residual Risks,
Uncertainties, and the Need for Ongoing Post-Market Surveillance
(PMS) Activities will be examined.
A release checklist will be prepeared for examine the quality and adequacy
of clinical evaluation report according to MEDDEV 2.7.1 Rev 4 section A10.

The following question will be checked for releasing of clinical evaluation

report:
Release Checklist for Clinical
Evaluation Report Questions Decision
Can the report be read and understood by a third
party, does it provide sufficient detail for
Yes No
understanding the data that are available, all
assumptions made and all conclusions reached?
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If clinical data have been generated and are held

by the manufacturer, are all data mentioned and Yes No
adequately summarised in the report?
If equivalence is claimed, - is demonstration of
equivalence included in the report?
- does the report disclose all the differences
between the device under evaluation and the
Yes No
equivalent device?
- does it explain why the differences are not
expected to affect the clinical performance and
clinical safety of the device?
If the product is already in the market in Europe or
elsewhere, has the latest PMS/ PMCF data been
Yes No
taken into consideration and has it been
summarized and referenced in the report?
In respect to current knowledge/ the state of the art,
− has the report been updated? Yes No
− is current knowledge/ the state of the art
summarised in the report and is it Yes No
adequately substantiated by literature?
− does the content of the report fully
correspond to current knowledge/ the state Yes No
of the art?
− does the report explain why the benefit/risk
profile and the undesirable side-effects are
Yes No
acceptable in relation to current
knowledge/ the state of the art?
If the report covers several models/ sizes/ settings and/or different clinical
situations, is there sufficient clinical evidence and are the report’s
conclusions correct for
all the devices? Yes No
all its sizes, models and settings? Yes No
every medical indication? Yes No
the entire target population? Yes No
every form, stage and severity of the medical
Yes No
condition, as applicable?
all intended users? Yes No
the whole duration of product use, including the
Yes No
maximal number of repeated exposure?
if there are any discrepancies as to the above, are
Yes No
they identified in the report’s conclusions?
s conformity to each of the relevant Essential
Requirements (MDR GSPR 1-6 ) clearly stated
Yes No
and are all discrepancies identified in the report’s
conclusions?
Do the information materials supplied by the
manufacturer correspond with the contents of the
Yes No
report and are all discrepancies identified in the
report’s conclusions?
Do the report’s conclusions identify all residual
risks and uncertainties or unanswered questions
Yes No
that should be addressed with PMS/ PMCF
studies?
Is the report dated? Yes No
Is the qualification of the evaluators included in
Yes No
the report and correct?
Does the manufacturer hold a CV and declaration
of interests of each of the evaluators and are these Yes No
up-to-date?