Equalance Comparission Data

Clinical Evaluation Report (CER) for <Device name>
CONFIDENTIAL
IF YOUR PRODUCT SATISFIES A MEDICAL NEED, EVEN THOUGH IT DOES NOT SEEM TO BE A MEDICAL DEVICE, IT
MIGHT NEED TO BE EVALUATED AS ONE.
1. DO NOT UNDERESTIMATE THE PRESCRIBED CHALLENGES OF INDUSTRY QUALITY AND REGULATORY

REQUIREMENTS. (These points are applicable to all industries.)
2. TAKE TIME TO UNDERSTAND CHALLENGES.
3. UNDERSTAND THE CONSEQUENCES OF TAKING SHORT CUTS.
ROUGH CER TEMPLATE WELCOME AND TIPS.
Welcome to my medical device clinical evaluation report (CER) rough template and tips!
THERE IS NO REGULATORY MANDATE TO USE THIS TEMPLATE.
Even if you don’t put this template to use, you might find it useful to read. While writing it I am also thinking about
medical devices and combination products. Like medical device combinations with advanced therapeutic medicinal
products (ATMP), biotech, biological and other pharmaceutical product types. Another thing is that your company
might not specialise in medical device manufacture. Yet you find you have a product that classifies as a medical
device because it satisfies a medical need.
CER templates are not ‘one size fits all’. This rough CER template is a starting point to help you get going. Please
alter it to fit your product needs. You might not have a need for a CER at all and this is something you need to check
for your product.
The Medical Device Regulation (MDR) applies from 26 May 2021. The In Vitro Diagnostics Regulation (IVDR) applies
from the 22 May 2022. Details on transition timelines should be at your regulatory authority website. Try setting up
an electronic notification in case of transition deadline delays.
This template might help get others to understand what you want to achieve.
Tips:
- Read your CER template at the beginning of your writing process to get an understanding of what you
need.
- Complete summary information at the end of your writing process. Doing this at the beginning is like
counting your chickens before they hatch. Waiting until the end might let you see if you missed something.
- Adjust your CER according to your product requirements at various stages during its development. This is
not a one-time exercise.
- Consider Quality Management System (QMS) and process requirements. What does your company have or
want to have? See MDR Regulation (EU) 2017/745 Annex IX; and IVDR Regulation (EU) 2017/746 Annex IX.
- Remember that lots of well-placed headings, tables and figures make it easier to read and maintain large
documents.
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development.
Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

CONFIDENTIAL
- Reference, within reason, where EVERY SINGLE PIECE of information has come from. It may seem tedious
to begin with. It will make a big difference to fact checking and project alignment down the road.
- Think about reference source dates too. Were they current when they were referenced?
- Do not discard superseded documents. It is mandatory to keep them. Keeping them shows how far your
product development has come.
- Do not reinvent the wheel when writing your CER, within reason. It is easier for people to verify content if
you keep the same wording as associated documents. It helps keep everything in agreement by not
introducing misinterpretations.
- Maintaining a compliant CER is a team effort that lasts for years. It is an output from compliance in other
areas of your business. Think about biostatistics, clinical operations, data managers, engineers, marketers,
material scientists, medical affairs, medical consultants, medical writers, production teams, quality
assurance, regulatory affairs and more if they are involved in your process. Or less, depending on where
you are in your process.

CONFIDENTIAL
IF YOUR PRODUCT SATISFIES A MEDICAL NEED, EVEN THOUGH IT DOES NOT SEEM TO BE A MEDICAL DEVICE, IT
MIGHT NEED TO BE EVALUATED AS ONE.

Useful weblinks:
Directives, guidelines and standards:

- European Commission Medical Device Sector -
https://ec.europa.eu/health/md_sector/current_directives_en
- European Commission Guidance MDCG endorsed documents -
https://ec.europa.eu/health/md_sector/new_regulations/guidance_en
- European Medicines Agency (EMA) Human regulatory Medical devices -
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices
- Eur-Lex Regulation (EU) 2017/745 (MDR) - https://eur-lex.europa.eu/legal-
content/EN/TXT/?uri=CELEX%3A32017R0745
- EUR-Lex Regulation (EU) 2017/746 (IVDR) - https://eur-lex.europa.eu/eli/reg/2017/746/oj
- MEDDEV guidance list -
- https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_guidance_meddevs.pdf
- https://www.medical-device-regulation.eu/meddev-guidance-list-download/
- International Standards Organization (ISO) - https://www.iso.org/search.html?q=medical%20device
- Emergo by UL - https://www.emergobyul.com/
- The Global Harmonization Task Force (GHTF) - http://www.ghtf.org/
- The International Medical Device Regulators Forum (IMDRF) - http://www.imdrf.org/
Databases for clinical trials, surveillance and literature reviews:

- EU Clinical Trials Register - https://www.clinicaltrialsregister.eu/
- The World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) -
https://www.who.int/ictrp/en/
- ClinicalTrials.gov - https://www.clinicaltrials.gov/
- European Commission EUDAMED - https://ec.europa.eu/health/md_eudamed/overview_en

- Manufacturer and User Facility Device Experience (MAUDE) -
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Total Product Life Cycle (TPLC) - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm
- Medical device incident reporting & investigation scheme (IRIS) - https://www.tga.gov.au/medical-device-
incident-reporting-investigation-scheme-iris
- Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) - http://www.prisma-
statement.org/
- Cochrane Handbook for Systematic Reviews of Interventions - https://training.cochrane.org/handbook
- Cochrane PICO searchBETA - https://www.cochranelibrary.com/about/pico-search
- Meta-analysis Of Observational Studies in Epidemiology (MOOSE) -
https://training.cochrane.org/handbook

CONFIDENTIAL
- Cochrane Central Register of Controlled Trials (CENTRAL) -

https://www.cochranelibrary.com/central/about-central
- PubMed - https://pubmed.ncbi.nlm.nih.gov/
- MEDLINE - https://www.nlm.nih.gov/bsd/medline.html
- Embase - https://www.embase.com/login
- ScienceDirect - https://www.sciencedirect.com/

CONFIDENTIAL
Document No: NNN-NNN-NNN Versoin: N.0 Date: DD MMM YYYY Commented [JB WS1]: Writing the first three letters of
the month prevents misinterpretation of the document
control date.
DOCUMENT TITLE
What date is 08 04 2020?
Clinical evaluation report (CER) for <Device name> 08 Apr 2020
Or
DOCUMENT HISTORY 04 Aug 2020
Document No Version Date Details of document change

001-001-001 1.0 01 Jan 1111 No changes as this is the first version of the CER.
NNN-NNN-NNN 2.0 DD MMM YYYY Document changes, not device changes, are concisely
listed here, e.g.,
- Section X.X had the following sub-headings

added/removed/replaced with:
Section X.X.X (Sub-heading title which should be self-
explanatory)
Section X.X.X.X (Sub-heading title which should be self-
explanatory)
- Minor changes were made to document formatting in
Sections X.X.X.X, X.X.X.X and X.X.X.X.
- Major changes to device development were reflected
in Sections X.X.X.X, X.X.X.X and X.X.X.X.
No need to provide reasons for changes to the

document here. All will become clear when the
changed sections are read.
SUMMARY
This clinical evaluation report (CER) contributes to product quality management. It satisfies aspects of the technical
documentation for <device name> (MDR Regulation (EU) 2017/745 Annexes II and III). Aspects include interfaces between
pre-clinical and clinical evaluation and:
1) Risk management.
2) Post-market surveillance (PMS) and associated corrective and preventive action (CAPA).
3) Post-market clinical follow-up (PMCF) including the plan <and report>.
This report shows conformity of the product with Medical Device Essential Requirements.
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page i of 41

CONFIDENTIAL
The CER outline:

- Agrees with <Directive 93/42/EEC (amended by Directive 2007/47/EC) Annex I Section 6a OR Directive
90/385/EEC (amended by Directive 2007/47/EC) Annex I Section 5a. As medical device regulations are
transitionsing, also see MDR Regulation (EU) 2017/745 Annex XIV on clinical evaluation and post-market clinical
follow-up (PMCF) and Annex XVII regulation correlation table>
- Considers MEDDEV guidelines for clinical investigations and evaluations.
See https://www.medical-device-regulation.eu/meddev-guidance-list-download/.
- Reflects the MDCG 2020-13 Clinical evaluation assessment report template (July 2020).
MDCG 2020-13 was prepared for notified bodies to use during device assessments. It was prepared by the
Medical Device Coordination Group (MDCG) who provides advice to the European Commission. The MDCG
assists in ensuring harmonised implementation of medical devices Regulations (EU) 2017/745 and 2017/746.
By considering MDCG 2020-13 the content of this CER is more intuitive for a notified body assessor to read.
<MDCG 2020-13 scope applies to:

- MDR Annex VII Requirements To Be Met By Notified Bodies, Section 4.5.5 and other relevant sections.
- MDR Annex IX Conformity Assessment Based On A Quality Management System And On Assessment Of
Technical Documentation, Sections 2.3, 3.5 and 4.
- MDR Annex X Conformity Assessment Based On Type-Examination, Section 3.
- MDR Annex XI(A) Production Quality Assurance, Section 10.
- Medical devices for which clinical data are not deemed appropriate, to demonstrate conformity with MDR
Annex I General Safety And Performance Requirements, and the demonstration of an adequate justification
for this.>
This CER contains information on:
Remove or add as applicable

- Claimed equivalent devices.
- New indications and innovations.
- Data for demonstrating conformity.
- Pre-clinical and clinical data.
- Risk analysis and management.
- General safety and performance requirements.
- The instructions for use.
- The user training and the manufacturer's PMS plan.
- The PMCF plan and data proposed, where applicable.
- The state-of-the-art.
THE overall NEED TO GENERATE CLINICAL DATA through clinical investigation HAS BEEN considered and REDUCED WHERE
POSSIBLE (MEDDEV 2.7/1 rev 4 2016). Compliance of the device to harmonised standards, precise data analyses, the choice
of selected medical indications and target populations reduces the need to generate clinical data. Where possible clinical
experience and literature reports of the safety and performance of an equivalent device have been used to establish
evidence.
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page ii of 41

CONFIDENTIAL
SCOPE
The CER is a living document that is updated <monthly, 6 monthly, or at least yearly for high risk devices OR every 2 - 5
years for devices without significant risks, as coordinated with the notified body (if one is used).> during device
development. The scope of each issue increases as more data is collected and reviewed in relation to the device. The
scope of this clinical evaluation report relates to <AIMDD as amended by directive 2007/47/EC OR the MDD as amended by
directive 2007/47/EC. It considers the transition to MDR Regulation (EU) 2017/745.>. All scope items are listed under
either ‘in this issue’ or ‘in future issues’. This is to maintain focus on device development goals. As device development
progresses scope items are relocated. They move from ‘in future issues’ to become ‘in this issue’ scope items.
In this issue:
-
In future issues:
These points are directly from MEDDEV 2.7/1 rev 4 (2016). Delete points if they do not apply to the scope of the report.
- Identification of devices covered by this clinical evaluation report, products, models, sizes, software versions,
accessories, their proprietary names, code names assigned during device development.
- Name and address of the manufacturer.
- Whether this clinical evaluation is submitted to the AIMDD as amended by directive 2007/47/EC, or to the MDD
as amended by directive 2007/47/EC.
- Concise physical and chemical description, including materials.
- Whether the device incorporated medicinal substances (already on the market or new), tissues, or blood
products.
- Mechanical and physicochemical characteristics; others (such as sterile vs. non-sterile, radioactivity etc.); picture
or drawing of the device.
- Technologies used, whether the device is based on a new technology, a new clinical application of an existing
technology, or the result of incremental change of an existing technology.
- Description of innovative aspects of the device.
- Device group the device belongs to.
- How the device achieves its intended purpose.
- Positioning in relation to available treatment/management/diagnostic options.
- Exact description of the intended purpose as described in the device's IFU20, with exact medical indications (if
applicable) and contraindications; claims made in available promotional materials.
- Name of disease or condition, clinical form, stage, severity, symptoms or aspects to be
treated/managed/diagnosed, target patient population, target user group.
- Intended application of the device, single use/reusable, invasive/non-invasive, implantable, duration of use or
contact with the body, maximum number of repeat applications.
- Identification of organs, tissues or body fluids contacted by the device.
- Precautions.
- Claims on clinical performance and clinical safety foreseen by the manufacturer.
- Whether the device is already CE marked, whether it is on the market, since when, in what regions, history of the
device, including date of past modifications with reasons and description, sales volumes.
- Changes since the last report, whether the device has been modified, identification of new products, models,
sizes, software, accessories, new intended purposes, new claims, new events related to the device with an impact
on clinical evaluation.
- Identification of the sections of the clinical evaluation report that are concerned with the new information and
have been modified.
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page iii of 41

CONFIDENTIAL
Distributing the clinical evaluation report for review and approval contributes to alignment of all aspects of the project.
DOCUMENT DISTRIBUTION LIST
Recipient: Department: Biostatistics
Recipient: Department: Clinical operations
Recipient: Department: Engineering
Recipient: Department: Marketing
Recipient: Department: Materials Science and Technology (MSAT)
Recipient: Department: Medical Affairs
Recipient: Department: Medical Consultant
Recipient: Department: Medical Writing
Recipient: Department: Production
Recipient: Department: Quality Assurance
Recipient: Department: Regulatory Affairs
Recipient: Department: More or less depending on your process.

REVIEW AND APPROVAL
Approved by: Title: Biostatistics Signed: Date:
Approved by: Title: Clinical operations Signed: Date:
Approved by: Title: Engineering Signed: Date:
Approved by: Title: Marketing Signed: Date:
Approved by: Title: MSAT Signed: Date:
Approved by: Title: Medical Affairs Signed: Date:
Approved by: Title: Medical Consultant Signed: Date:
Approved by: Title: Medical Writing Signed: Date:
Approved by: Title: Production Signed: Date:
Approved by: Title: Quality Assurance Signed: Date:
Approved by: Title: Regulatory Affairs Signed: Date:
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page iv of 41

CONFIDENTIAL
ACRONYMS AND DEFINITIONS LIST

Complete an acronyms and definitions list as you write. This will help the reader understand CER content
faster.
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 medical 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
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page v of 41

CONFIDENTIAL
TABLES LIST
Complete a tables list and references to page numbers. Maintaining this list helps keep track of what
should be added.
The table legend provokes thought. Like what data needs to be collected to get a CE mark. Or, what
information can be presented in an easy-to-digest way.
Table 1 Administrative particulars related to the notified body, manufacturer, product and clinical
evaluation report references. .................................................................................................................... viii
Table 2 List of common specifications applied in part or full. ...................................................................... 2
Table 3 List of common standards applied in part or full. ............................................................................ 2
Table 4 Matrix of Essential Requirements being applicable or not to an Investigational Medical Device
(IMD) with rationale (MEDDEV 2.7/2 Revision 2, 2015). ER = Essential Requirement. .............................. 15
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page vi of 41

CONFIDENTIAL
FIGURES LIST
Complete a figures list and references to page numbers. Maintaining this list helps keep track of what
should be added.
The figure legend provokes thought. Like what data needs to be collected to get a CE mark. Or, what
information can be presented in an easy-to-digest way.
No table of figures entries found.
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page vii of 41

CONFIDENTIAL
ADMISTRATIVE PARTICULARS
This table reflects the MDCG 2020—13 Clinical evaluation assessment report template (July 2020).
Table 1 Administrative particulars related to the notified body, manufacturer, product and clinical evaluation report references.
a) Device particulars:
Codes per
Basic UDI-DI Certificate No Regulation (EU)
(if available) (if applicable) Project number Risk class 2017/2185:
See:
-MEDDEV 2.4/1
Rev. 9 (June 2010)
and
-MDR Annex VIII
b) Manufacturer particulars:
Authorised representative name and SRN
Manufacturer(s) name and SRN (if applicable)
c) Notified body particulars:

Notified body email Notified body
Notified body Notified body number contact telephone contact
d) This report satisfies notified body assessment for:

Initial conformity Changes and updates Re-certification Class IIa/IIb sampling
e) Intended purpose description
f) Clinical evaluation report authors list
g) Notified body general and specific assessment considerations covered
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page viii of 41

CONFIDENTIAL
✓/×
GENERAL CONSIDERATIONS
Administrative particulars
Reviewers involved
Device description
Classification
Clinical evaluation plan
Information materials supplied by the manufacturer
Common specifications
Harmonised standards applied
Equivalence
State-of-the-art
Clinical literature review
Clinical investigations and related documentation
Post-market surveillance (PMS) and post-market clinical follow-up (PMCF)
Instructions for use (IFU)
Summary of safety and clinical performance (SSCP)
Labelling
Other information supplied with the device
Summary of all available data and conclusions
Overall conclusions
SPECIFIC CONSIDERATIONS
Clinical evaluation consultation procedure for certain class III and class IIb devices
(MDR Article 54)
Conformity demonstration based on clinical data not deemed appropriate (MDR Article 61(10))
Voluntary clinical consultation on the clinical development strategy (MDR Article 61(2))
h) Technical file identification and technical documentation assessment report (TDAR) reference
numbers if available or any other references that allow correlation between TDAR and CEAR
Version
Document type Title number/reference Document date ✓/×
Clinical evaluation report
Clinical investigation plan
Clinical investigation report
Ethics committee approval
Competent authority approval
Post-market surveillance data
Publications
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page ix of 41

CONFIDENTIAL
TABLE OF CONTENTS
DOCUMENT TITLE .......................................................................................................................................... i
DOCUMENT HISTORY ..................................................................................................................................... i
SUMMARY ...................................................................................................................................................... i
SCOPE ........................................................................................................................................................... iii
DOCUMENT DISTRIBUTION LIST .................................................................................................................. iv
REVIEW AND APPROVAL .............................................................................................................................. iv
ACRONYMS AND DEFINITIONS LIST .............................................................................................................. v
TABLES LIST .................................................................................................................................................. vi
FIGURES LIST ............................................................................................................................................... vii
ADMISTRATIVE PARTICULARS .................................................................................................................... viii
TABLE OF CONTENTS..................................................................................................................................... x
1 Summary (of the clinical evaluation report) ......................................................................................... 1
2 Scope of the clinical evaluation ............................................................................................................ 1
Sources of literature ................................................................................................................................. 2
3 Clinical background, current knowledge, state-of-the-art ................................................................... 3
4 Device under evaluation ....................................................................................................................... 3
4.1 Type of evaluation ........................................................................................................................ 4
4.2 Demonstration of equivalence (only if claimed)........................................................................... 4
4.3 Clinical data generated and held by the manufacturer ................................................................ 5
4.4 Clinical data from literature .......................................................................................................... 6
4.5 Summary and appraisal of clinical data ........................................................................................ 7
4.6 Analysis of clinical data ................................................................................................................. 9
4.6.1 Requirement on safety ......................................................................................................... 9
4.6.2 Requirement on acceptable benefit/risk profile ................................................................ 10

This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page x of 41

CONFIDENTIAL
4.6.3 Requirement on performance ............................................................................................ 10
4.6.4 Requirement on acceptability of side-effects. .................................................................... 10
5 Conclusions ......................................................................................................................................... 11
6 Date of the next clinical evaluation .................................................................................................... 11
7 Dates and signatures........................................................................................................................... 12
8 Qualification of the responsible evaluators ........................................................................................ 13
9 References .......................................................................................................................................... 13
State-of-the-art literature ....................................................................................................................... 13
Systematic review literature ................................................................................................................... 13
Appendix X: Author curriculum vitaes ........................................................................................................ 14
Appendix X: Checklists ................................................................................................................................ 15
Checklist: Essential requirements ........................................................................................................... 15
This is a medical device CER rough template (July 2020). Alter it to suit the needs of your device development. Page xi of 41

CONFIDENTIAL
1 Summary (of the clinical evaluation report)

See MEDDEV 2.7/1 revision 4 (2016) A9. Also see MDR Regulation (EU) 2017/745 Annex XIV on clinical
evaluation and post-market clinical follow-up (PMCF).
This section is best written after completing the issue. It is only after completion that it is possible to
summarise what the contents of the document are. An executive summary allows readers to acquaint
themselves with large reports fast.
Summarise your determination of the benefit/risk profile. Think of intended target groups and medical
indications. Show acceptability of the profile compared to the state-of-the-art.
This report outlines the clinical evaluation for <medical device name, model and type>.
Provide a concise overview of the report over about 2 pages. Think about including information on:
- The device under evaluation.
- Target population and treatment to be given.
- State-of-the-art.
- Pre-clinical studies.
- Post-market surveillance.
- Risk management.
- Published literature.
- Risk-benefit profile.
- Evaluation conclusions.
2 Scope of the clinical evaluation

See MEDDEV 2.7/1 revision 4 (2016) Sections 7, 8.1, A3, A4 and A9. Also see MDR Regulation (EU)
2017/745 Article 9(3) and Annex XIV on clinical evaluation and post-market clinical follow-up (PMCF).
The scope sets out the goals of the CER. The main goal is to show conformity of the device compared to
Essential Requirements.
Think about devices yet to be CE marked - is equivalence data applicable?
Consider the following for all CERs:

- Device description
- Design features.
- Risk management.
- State-of-the-art.
- Data sources and types.
This is a rough CER template (July 2020). Alter it to suit the needs of your device development. Page 1 of 41

CONFIDENTIAL
If the device is CE marked think about changes to design, material, IFU, administrative changes and so
on. Are equivalence claims still appropriate? Think about new clinical concerns, new PMS data and PMS
planning.
Sources of literature
Here are examples of where tables might be useful to make information easier to digest. Literature
sources could be tabulated to show if they were used partially or fully.
Reference compliance with common specifications, standards and other solutions relevant to the device
under evaluation. If they have not been complied with consider how deviations affect the validity of the
clinical evaluation, its conclusions, and any equivalence claims. Justify why other solutions are
appropriate to use.
Table 2 List of common specifications applied in part or full.

Compliance
Partial
Description of all deviations and of the alternative
Specification solutions adopted to meet the essential requirements
identifier and title Version/year Full of directive 90/385/EEC or 93/42/EEC.
✓/× ✓/×
 
 
 
 
Table 3 List of common standards applied in part or full.

Compliance
Partial
Description of all deviations and of the alternative
Standard solutions adopted to meet the essential requirements
identifier and title Version/year Full of directive 90/385/EEC or 93/42/EEC.
✓/× ✓/×
 
 
 
 

CONFIDENTIAL
3 Clinical background, current knowledge, state-of-the-art

See MEDDEV 2.7/1 revision 4 (2016) Sections 8-10 and Appendices A4-A5 and A9. Also see MDR
Regulation (EU) 2017/745 Annex XIV on clinical evaluation and post-market clinical follow-up (PMCF).
This section should read like a review of literature. Consider it as an introduction to CER section 4. Some
headings might reflect those for the device under evaluation (CER section 4) to compare to the state-of-
the-art. Only the bibliography list supporting the state-of-the-art should be referenced here. Consider
data generated and held by the manufacturer and retrieved from literature.
Consider the device under evaluation and create broad search terms. Be objective. Consider a method to
appraise the data and how to report it objectively.
When this section is complete consider how the device under evaluation compares to the state-of-the-
art.
4 Device under evaluation

See MEDDEV 2.7/1 revision 4 (2016) Sections A3 and A9. Also see MDR Regulation (EU) 2017/745 Annex
XIV on clinical evaluation and post-market clinical follow-up (PMCF). Also see MEDDEV 2.4/1 revision 9
(June 2010) and MDR Regulation (EU) 2017/745 Annex VIII.
CER section 4 should contain most of the tables and figures in the report. Provide enough detail to assess
compliance with Essential Requirements (Table 4 of this template). Cross reference to relevant sections
of the manufacturer’s technical information as appropriate.
Describe the device under evaluation. Think about including:

- Device name, models, sizes/settings, components of the device, including software and
accessories.
- Device group to which the device belongs, e.g., biological artificial aortic valve.
- Whether the device is being developed/undergoing initial CE-marking/is already CE-marked.
- Whether the device is currently on the market in Europe or in other countries and since when,
and the number of devices placed on the market.
The device intended purpose:

- Exact medical indications, if applicable.
- Name of disease or condition/clinical form, stage, severity/symptoms or aspects to be treated,
managed or diagnosed.
- Patient populations, like adults/children/infants, other aspects.
- Intended user, like use by health care professional/lay person.
- Organs/parts of the body/tissues or body fluids contacted by the device.

CONFIDENTIAL
- Duration of use or contact with the body.

- Repeat applications, including any restrictions as to the number or duration of reapplications.
- Contact with mucosal membranes/invasiveness/implantation.
- Contraindications.
- Precautions required by the manufacturer.
- Single use/reusable.
- Other aspects.
A general device description:

- A concise physical and chemical description.
- Qualitative and quantitative description. For example, information collected through observation
and interview is qualitative; and information collected through measurement is quantitative.
- 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 coming in direct or indirect contact 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.
4.1 Type of evaluation

See MEDDEV 2.7/1 revision 4 (2016) Section 10.3 and A9. Also see MDR Regulation (EU) 2017/745 Annex
XIV on clinical evaluation and post-market clinical follow-up (PMCF).
Think about if the clinical evaluation is based on:
1. Scientific literature currently available, and/or clinical investigations.
Or
2. Whether demonstration of conformity with essential requirements based on clinical data is not
appropriate with justification.
4.2 Demonstration of equivalence (only if claimed)

See MEDDEV 2.7/1 revision 4 (2016) A1 and A9. Also see MDR Regulation (EU) 2017/745 Annex XIV on
clinical evaluation and post-market clinical follow-up (PMCF).

CONFIDENTIAL
Equivalence means no significant clinical difference in performance and safety is observed between the
device and ONE already marketed. Showing equivalence reduces the need for clinical testing. It is
important to disclose characteristics that do not show equivalence. Clinical, technical and biological
characteristics are considered to DEMONSTRATE EQUIVALENCE BASED ON ONE SINGLE DEVICE.
Technical:
- The device is of similar design to the device under evaluation.
- It is used under similar conditions of use.
- Has similar specifications and properties including physicochemical properties such as intensity
of energy, tensile strength, viscosity, surface characteristics, wavelength and software
algorithms.
- Uses similar deployment methods, where relevant.
- Has similar principles of operation and critical performance requirements.
Biological:
- The device uses the same materials or substances in contact with the same human tissues or
body fluids for a similar kind and duration of contact and similar release characteristics of
substances, including degradation products and leachables.
Clinical:
- The device is used for the same clinical condition or purpose, including similar severity and stage
of disease, at the same site in the body.
- In a similar population, including as regards age, anatomy and physiology,
- Has the same kind of user.
- Has similar relevant critical performance in view of the expected clinical effect for a specific
intended purpose.
4.3 Clinical data generated and held by the manufacturer

Identify clinical data generated and held by the manufacture like:

- All pre market clinical investigations.
- Risk management and PMS data.

- PMCF studies, such as post market clinical investigations and any device registries
sponsored by the manufacturer.
- PMS reports, including vigilance reports and trend reports
- The literature search and evaluation reports for PMS.

CONFIDENTIAL
- Incident reports sent to the manufacturer, including the manufacturer’s own evaluation
and report.
- Complaints regarding performance and safety sent to the manufacturer, including the
manufacturer’s own evaluation and report.
- Analysis of explanted devices, as far as available.
- Details of all field safety corrective actions.
- Use as a custom-made device.
- Use under compassionate use humanitarian exemption programs.
- Other user reports.
- Relevant pre-clinical studies, e.g., bench test reports including verification and validation data.
With regard to data:

- All data generated and held by the manufacturer needs to be identified.
- Complete data need to be entirely disclosed and made available to the evaluators; this includes
data from Europe and other countries; it includes clinical studies as well as use data.
- All data sets should be documented, adequately summarised, appraised, analysed and
referenced, in the clinical evaluation report.
4.4 Clinical data from literature

See MEDDEV 2.7/1 revision 4 (2016) Section 8.2, A4-A6 and A9. Also see MDR Regulation (EU) 2017/745
Annex XIV on clinical evaluation and post-market clinical follow-up (PMCF).
Summarise and justify the literature search strategy applied for retrieval of clinical data. Include
objectives, sources used, search questions, search terms, selection criteria applied to the output of the
search, quality control measures, results, number and type of literature found to be pertinent.
Literature searches identify data, not held by the manufacturer, needed for clinical evaluation:
- Clinical data relevant to the device under evaluation, which are data that relate either to the
device under evaluation or to the equivalent device, only if claimed.
- Current knowledge/the state-of-the-art. Includes applicable standards and guidance documents,
data that relate to benchmark devices, other devices, critical components and medical
alternatives or to the specific medical conditions and patient populations intended to be
managed with the device. State-of-the-art data are typically needed to:
- Describe the clinical background and identify the current knowledge state-of-the-art in
the corresponding medical field.
- Identify potential clinical hazards, including hazards due to substances and technologies,
manufacturing procedures and impurity profiles.
- Justify the validity of criteria used for the demonstration of equivalence, if equivalence is
claimed.

CONFIDENTIAL
- Justify the validity of surrogate endpoints, if surrogate endpoints are used.
The following aspects should be considered for literature searching:

- The searching strategy should be thorough and objective, i.e. it should identify all relevant
favourable and unfavourable data.
For some devices, clinical data generated through literature searching will represent the greater
part, if not all, of the clinical evidence. Thus, when conducting a literature review a
comprehensive search should be conducted. If a comprehensive search is not deemed necessary,
reasons should be documented.
- Several searches with different search criteria or focus are usually necessary to obtain the
necessary data.
- A literature search and other retrieval of data are carried out based on a search protocol. The
search protocol documents the planning of the search before execution.
- Once the searches have been executed, the adequacy of the searches 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 such degree that the methods can be
appraised critically, the results can be verified, and the search reproduced if necessary.
Abstracts lack sufficient detail to allow issues to be evaluated 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 appraisal stage.
The literature search protocol(s), the literature search report(s), and full text copies of relevant
documents, become part of the clinical evidence and, in turn, the technical documentation for the
medical device.
4.5 Summary and appraisal of clinical data

See MEDDEV 2.7/1 revision 4 (2016) Section 9, A6 and A9. Also see MDR Regulation (EU) 2017/745
Determine the value of identified data by conducting an appraisal. Appraise the contribution of each
individual document for the clinical performance and clinical safety evaluation of the device.
Analyse sources of uncertainty and give appraised data sets ratings. Sources of uncertainty are generally
found in the methodological quality of the data, and the relevance of the data to the evaluation of the
device in relation to the different aspects of its intended purpose.

CONFIDENTIAL
For appraisal and evaluation of data:

- Identify information contained in each document.
- Evaluate the methodological quality of work done by the authors and from that, the scientific
validity of the information.
- Determine the relevance of the information to the clinical evaluation.
- Systematically weight the contribution of each data set to the clinical evaluation.
Consider these headings and sub-headings:

- Feasibility Studies
- Brief summary of the studies or references including methods, results, conclusion of the
authors.
- Evaluation of their methodological quality.
- Scientific validity of contents.
- Relevance to the clinical evaluation.
- Weighting attributed to the data.
- Contents used for performance data and/or safety data and reasons for rejecting a study or
document.
- Reasons for rejecting some of its contents.
- Pivotal clinical investigations.

authors.
document.
- PMCF Studies.
authors.
document.

CONFIDENTIAL
- Other use data.

authors.
document.
4.6 Analysis of clinical data

See MEDDEV 2.7/1 revision 4 (2016) Section 10 and A7 and A9. Also see MDR Regulation (EU) 2017/745
4.6.1 Requirement on safety

See MEDDEV 2.7/1 revision 4 (2016) Section 10 and A7.1 and A9. Also see MDR Regulation (EU)
2017/745 Annex XIV on clinical evaluation and post-market clinical follow-up (PMCF).
Complete this content:

- Summarise the conformity assessment with Essential Requirement on safety (MDD Essential
Requirement (ER) 1/AIMDD ER 1).
- Analyse whether there are special design features that pose special safety concerns, e.g.,
presence of medicinal, human or animal components, identified in the device risk management
documentation and that required evaluation from a clinical perspective, and if they have been
adequately addressed.
- Describe whether risks in the risk management documentation and literature have been
adequately addressed.
- Describe whether hazards and other clinically relevant information, e.g., clinical precautions for
reduction of risks, clinical management of risks, have been identified appropriately.
- Describe whether safety characteristics and intended purpose of the device requires training of
the end-user or other precautions, if users foreseen are adequate, if training requirements and
other precautions are described in the IFU.
- Describe whether there is full consistency between current knowledge/the state-of-the-art, the
available clinical data, the information materials supplied by the manufacturer, and the risk
management documentation for the device.

CONFIDENTIAL
4.6.2 Requirement on acceptable benefit/risk profile

Complete this content:

Summarise the conformity assessment with Essential Requirements on acceptable benefit/risk
profile(MDD ER1/AIMDD ER1).
Summarise the total experience with the device including:

- Estimated numbers and characteristics of patients exposed to the device in clinical
investigations.
- PMCF, from other user experience, and in the market; duration of follow-up.
- Nature, extent/severity, probability/frequency, duration of benefits to the patients and of
undesirable side-effects and other risks.
For each aspect of the intended purpose describe if the benefit/risk profile including its uncertainties or
unanswered questions is compatible with a high level of protection of health and safety, corresponding
justifications.
4.6.3 Requirement on performance

Summarise the conformity assessment with requirement on performance (MDD ER3/AIMDD ER2)
compared to collected data:
- Describe the intended clinical performance.
- Extent that evaluation of benefits is possible based on available data.
- Limitations of the data.
- Description of gaps.
- Uncertainties or unanswered questions and assumptions.
4.6.4 Requirement on acceptability of side-effects.

Summarise the conformity assessment with Essential Requirements on acceptability of undesirable side-
effects (MDD ER6/AIMDD ER5). Consider the following headings:
- Whether available data is of sufficient amount and quality for the detection of undesirable side-
effects and their frequency.
- Limitations of the data.

CONFIDENTIAL
- Description of gaps.
- Uncertainties or unanswered questions and assumptions.
- Whether undesirable side-effects are acceptable and corresponding justifications.
5 Conclusions
See MEDDEV 2.7/1 revision 4 (2016) Section 11 and A9. Also see MDR Regulation (EU) 2017/745 Annex
Consider the following content:

- A clear statement concerning compliance to Essential Requirements.
- Benefit/risk profile acceptability according to current knowledge/the state-of-the-art in the
medical fields concerned and according to available medical alternatives.
- Adequacy of the information materials supplied by the manufacturer.
- Whether the intended purpose and risk reduction measures are adequate; discrepancies.
- Suitability of the device, including its IFU, for the intended users and usability aspects;
discrepancies.
- Adequacy of claims foreseen by the manufacturer; discrepancies.
- Whether there is consistency between the clinical data, the information materials supplied by the
manufacturer, the risk management documentation for the device under evaluation;
discrepancies.
- Whether there is consistency between these documents and the current knowledge/the state-of-
the-art; discrepancies.
- Description of residual risks and uncertainties or unanswered questions, whether these are
acceptable for CE-marking, how these should be followed during PMS. Uncertainties include
those regarding medium- and long-term performance, safety under wide-spread use, residual
risks such as undesirable side-effects and complications occurring at rates below detection
possibilities of currently available clinical data, and others.
- Whether uncertainties are already being addressed in ongoing PMS activities, e.g., in currently
ongoing PMCF studies.
- Whether new or additional PMS activities, including PMCF studies, should be foreseen.

6 Date of the next clinical evaluation

See MEDDEV 2.7/1 revision 4 (2016) Section 6.2.3 and A9. Also see MDR Regulation (EU) 2017/745

CONFIDENTIAL
The manufacturer should define and justify the frequency at which the clinical evaluation needs to be
updated considering:
- Whether the device carries significant risks. For example, based on design, materials,
components, invasiveness, clinical procedures, high-risk anatomical locations, high-risk target
populations, e.g., paediatrics, elderly, severity of disease treatment challenges.
- Whether the device is well established, taking into consideration.

- Innovation.
- Relevant changes in clinical sciences, materials sciences or other sciences related to the
device under evaluation.
- The current level of confidence in the evaluation of clinical performance and clinical safety
of the device; the manufacturer should consider:
- The data available from clinical investigations, PMCF studies, registries or other.
- Systematic studies, including the number of devices used, if that usage was
representative of the usage in the market, the results to date.
- The total number of devices used so far in the market, and expected reporting rates under
the vigilance system.
- Whether there are risks and uncertainties or unanswered questions, in the medium- or long-
term, that would influence the frequency of updates.
- Design changes or changes to manufacturing procedures, if any.
The clinical evaluation is actively updated:

- When the manufacturer receives new information from PMS that has the potential to change the
current evaluation.
- Whether no such information is received, then:
- At least annually if the device carries significant risks or is not yet well established; or
- Every 2 to 5 years if the device is not expected to carry significant risks and is well
established, a justification should be provided.
When involvement of notified bodies is required, updates are usually coordinated with them. Typically,
they are aligned with the timetable for surveillance audits and the renewal of the certificates.
7 Dates and signatures

See MEDDEV 2.7/1 revision 4 (2016) Section 11, A9, and A10. Also see MDR Regulation (EU) 2017/745
Consider the following contents:

- Can the report be easily understood by a third party?
- The date of the clinical evaluation report.

CONFIDENTIAL
- A statement that the evaluators agree with the contents of the report.
- Dates, names and signatures of the evaluators.
- Final report release by the manufacturer including the date, name and signature of the report
release approver(s).
8 Qualification of the responsible evaluators

The clinical evaluation should be conducted by a suitably qualified individual or a team.
9 References
See MEDDEV 2.7/1 revision 4 (2016) Section 11 and A9. Also see MDR Regulation (EU) 2017/745 Annex
Maintain bibliography sections supporting the state-of-the-art and the systematic review of literature
State-of-the-art literature
State-of-the-art is generally accepted as no more than 2 years before the clinical evaluation date.
If a reference is applicable to supporting the state-of-the-art and the systematic review, include it under
both bibliography headings.
Systematic review literature

If a reference is applicable to supporting the state-of-the-art and the systematic review, include it under
both bibliography headings.

CONFIDENTIAL
Appendices are included in this rough CER template and may not be a requirement of your submitted
clinical evaluation report (CER). Delete appendices as appropriate.
Appendix X: Author curriculum vitaes

CONFIDENTIAL
Appendices are included in this rough CER template and may not be a requirement of your submitted
clinical evaluation report (CER). Delete appendices as appropriate.
Appendix X: Checklists
Checklist: Essential requirements
Table 4 Matrix of Essential Requirements being applicable or not to an Investigational Medical Device (IMD) with rationale
(MEDDEV 2.7/2 Revision 2, 2015). ER = Essential Requirement.
I. GENERAL REQUIREMENTS
Does ER apply
to the device? Reference Evidence of conformance Justification/comment in case of
✓/× used to standard; documents deviation
ER 1. The devices must be designed and manufactured in such a way that, when used under the
conditions and for the purposes intended, they will not compromise the clinical condition or the
safety of patients, or the safety and health of users or, where applicable, other persons, provided that
any risks which may be associated with their use constitute acceptable risks when weighed against
the benefits to the patient and are compatible with a high level of protection of health and safety.
This shall include:
- Reducing, as far as possible, the risk of use error due to ergonomic features of the device and
the environment in which the device is intended to be used (design for patient safety).
- Consideration of the technical knowledge, experience, education and training and where
applicable the medical and physical conditions of intended users (design for lay, professional,
disabled or other users).
ER 2. The solutions adopted by the manufacturer for the design and construction of the devices must
conform to safety principles, taking account of the generally acknowledged state-of-the-art. In
selecting the most appropriate solutions, the manufacturer must apply the following principles in the
following order:
- Eliminate or reduce risks as far as possible (inherently safe design and construction).
- Where appropriate take adequate protection measures including alarms if necessary, in
relation to risks that cannot be eliminated.
- Inform users of the residual risks due to any shortcomings of the protection measures
adopted.
ER 3. The device must achieve the performances intended by the manufacturer and be designed,
manufactured, and packaged in such a way that it is suitable for one or more of the functions referred
to in Article 1 (2) (a), as specified by the manufacturer.
ER 4. The characteristics and performances referred to in Sections 1, 2 and 3 must not be adversely
affected to such a degree that the clinical conditions and safety of the patients and, where applicable,
of other persons are compromised during the lifetime of the device as indicated by the manufacturer,
when the device is subjected to the stresses which can occur during normal conditions of use.

CONFIDENTIAL
I. GENERAL REQUIREMENTS
Does ER apply
ER 5. The devices must be designed, manufactured and packed in such a way that their characteristics
and performances during their intended use will not be adversely affected during transport and
storage taking account of the instructions and information provided by the manufacturer.
ER 6. Any undesirable side effect must constitute an acceptable risk when weighed against the
performances intended.
ER 6a. Demonstration of conformity with the essential requirements must include a clinical evaluation
in accordance with Annex X.
II. REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION

Does ER apply
ER 7. Chemical, physical and biological properties
ER 7.1. The devices must be designed and manufactured in such a way as to guarantee the
characteristics and performances referred to in Section I on the ‘General requirements’. Particular
attention must be paid to:
- The choice of materials used, particularly as regards toxicity and, where appropriate,
flammability.
- The compatibility between the materials used and biological tissues, cells and body fluids,
taking account of the intended purpose of the device.
- Where appropriate, the results of biophysical or modelling research whose validity has been
demonstrated beforehand.
ER 7.2. The devices must be designed, manufactured and packed in such a way as to minimise the risk
posed by contaminants and residues to the persons involved in the transport, storage and use of the
devices and to the patients, taking account of the intended purpose of the product. Particular
attention must be paid to the tissues exposed and to the duration and frequency of exposure.
ER 7.3. The devices must be designed and manufactured in such a way that they can be used safely
with the materials, substances, and gases with which they enter into contact during normal use or
during routine procedures; if the devices are intended to administer medicinal products they must be
designed and manufactured in such a way as to be compatible with the medicinal products concerned

CONFIDENTIAL

Does ER apply
according to the provisions and restrictions governing these products and that their performance is
maintained in accordance with the intended use.
ER 7.4. Where a device incorporates, as an integral part, a substance which, if used separately, may
be considered to be a medicinal product as defined in Article 1 of Directive 2001/83/EC and which is
liable to act upon the body with action ancillary to that of the device, the quality, safety and
usefulness of the substance must be verified by analogy with the methods specified in Annex I to
Directive 2001/83/EC.
- For the substances referred to in the first paragraph, the notified body shall, having verified
the usefulness of the substance as part of the medical device and taking account of the
intended purpose of the device, seek a scientific opinion from one of the competent
authorities designated by the Member States or the European Medicines Agency (EMA) acting
particularly through its committee in accordance with Regulation (EC) No 726/2004 (*) on the
quality and safety of the substance including the clinical benefit/risk profile of the
incorporation of the substance into the device. When issuing its opinion, the competent
authority or the EMA shall take into account the manufacturing process and the data related
to the usefulness of incorporation of the substance into the device as determined by the
notified body.
ER 7.4 (continued):
- Where a device incorporates, as an integral part, a human blood derivative, the notified body
shall, having verified the usefulness of the substance as part of the medical device and taking
into account the intended purpose of the device, seek a scientific opinion from the EMEA,
acting particularly through its committee, on the quality and safety of the substance including
the clinical benefit/risk profile of the incorporation of the human blood derivative into the
device. When issuing its opinion, the EMEA shall take into account the manufacturing process
and the data related to the usefulness of incorporation of the substance into the device as
determined by the notified body.
ER 7.4 (continued):
- Where changes are made to an ancillary substance incorporated in a device, in particular
related to its manufacturing process, the notified body shall be informed of the changes and
shall consult the relevant medicines competent authority (i.e. the only involved in the initial
consultation), in order to confirm that the quality and safety of the ancillary substance are
maintained. The competent authority shall take into account the data related to the
usefulness of incorporation of the substance into the device as determined by the notified

CONFIDENTIAL

Does ER apply
body, in order to ensure that the changes have no negative impact on the established
benefit/risk profile of the addition of the substance in the medical device.
- When the relevant medicines competent authority (i.e. the one involved in the initial
consultation) has obtained information on the ancillary substance, which could have an
impact on the established benefit/risk profile of the addition of the substance in the medical
device, it shall provide the notified body with advice, whether this information has an impact
on the established benefit/risk profile of the addition of the substance in the medical device
or not. The notified body shall take the updated scientific opinion into account in
reconsidering its assessment of the conformity assessment procedure.
ER 7.5. The devices must be designed and manufactured in such a way as to reduce to a minimum the
risks posed by substances leaking from the device. Special attention shall be given to substances
which are carcinogenic, mutagenic or toxic to reproduction, in accordance with Annex I to Directive
67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions
relating to the classification, packaging and labeling of dangerous substances.
- If parts of the device (or device itself) intended to administer and/or remove medicines, body
liquids or other substances to or from the body, or devices intended for transport and storage
of such body fluids or substances, contain phthalates which are classified as carcinogenic,
mutagenic or toxic to reproduction, of category 1 or 2, in accordance with Annex 1 to
Directive 67/548/EEC, these devices must be labelled on the device itself and/or on the
packaging for each unit, or, where appropriate, on the sale packaging as a device containing
phthalates.
ER 7.5 (continued):
- If the intended use of such devices includes treatment of children or treatment of pregnant or
nursing women, the manufacturer must provide a specific justification for the use of these
substances with regard to compliance with the essential requirements, in particular of this
paragraph, within the technical documentation and within the instructions of use information
on residual risks for these patient groups and, if applicable, on appropriate precautionary
measures.
ER 7.6. Devices must be designed and manufactured in such a way as to reduce, as much as possible,
risks posed by the unintentional ingress of substances into the device taking into account the device
and the nature of the environment in which it is intended to be used.

CONFIDENTIAL

Does ER apply
ER 8. Infection and microbial contamination
ER 8.1. The devices and manufacturing processes must be designed in such a way as to eliminate or
reduce as far as possible the risk of infection to the patient, user, and third parties. The design must
allow easy handling and, where necessary, minimise contamination of the device by the patient or
vice versa during use.
ER 8.2. Tissues of animal origin must originate from animals that have been subjected to veterinary
controls and surveillance adapted to the intended use of the tissues. Notified bodies shall retain
information on the geographical origin of the animals. Processing, preservation, testing, and handling
of tissues, cells, and substances of animal origin must be carried out so as to provide optimal security.
In particular, safety with regard to viruses and other transmissible agents must be addressed by
implementation of validated methods of elimination or viral inactivation in the course of the
manufacturing process.
ER 8.3. Devices delivered in a sterile state must be designed, manufactured, and packed in a non-
reusable pack and/or according to appropriate procedures to ensure that they are sterile when placed
on the market and remain sterile, under the storage and transport conditions laid down, until the
protective packaging is damaged or opened.
ER 8.4. Devices delivered in a sterile state must have been manufactured and sterilised by an
appropriate, validated method.
ER 8.5. Devices intended to be sterilised must be manufactured in appropriately controlled (e.g.

environmental) conditions.
ER 8.6. Packaging systems for non-sterile devices must keep product without deterioration at the
level of cleanliness stipulated and, if the devices are to be sterilised prior to use, minimise the risk of
microbial contamination; the packaging system must be suitable, taking account of the method of
sterilisation indicated by the manufacturer.
ER 8.7. The packaging and/or label of the device must distinguish between identical or similar
products sold in both sterile and non-sterile condition.
ER 9. Construction and environmental properties

ER 9.1. If the device is intended for use in combination with other devices or equipment, the whole
combination, including the connection system must be safe and must not impair the specified

CONFIDENTIAL

Does ER apply
performances of the devices. Any restrictions on use must be indicated on the label or in the
instructions for use.
ER 9.2. Devices must be designed and manufactured in such a way as to remove or minimise as far as
is possible:
- The risk of injury, in connection with their physical features, including the volume/pressure
ratio, dimensional and, where appropriate, ergonomic features.
ER 9.2 (continued):
- Risks connected with reasonable foreseeable environmental conditions, such as magnetic
fields, external electrical influences, electrostatic discharge, pressure, temperature or
variations in pressure and acceleration.
ER 9.2 (continued):
- Risks of reciprocal interference with other devices normally used in the investigations or for
the treatment given.
ER 9.2 (continued):
- risks arising where maintenance or calibration is not possible (as with implants), from aging of
materials used or loss of accuracy of any measuring or control mechanism.
ER 9.3. Devices must be designed and manufactured in such a way as to minimise the risks of fire or
explosion during normal use and in single fault condition. Particular attention must be paid to devices
whose intended use includes exposure to flammable substances or to substances that could cause
combustion.
ER 10. Devices with a measuring function

ER 10.1. Devices with a measuring function must be designed and manufactured in such a way as to
provide sufficient accuracy and stability within appropriate limits of accuracy and taking account of
the intended purpose of the device. The limits of accuracy must be indicated by the manufacturer.
ER 10.2. The measurement, monitoring and display scale must be designed in line with ergonomic
principles, taking account of the intended purpose of the device.
ER 10.3. The measurements made by devices with a measuring function must be expressed in legal
units conforming to the provisions of Council Directive 80/181/EEC.

CONFIDENTIAL

Does ER apply
ER 11. Protection against radiation

ER 11.1. General
ER 11. 1.1. Devices shall be designed and manufactured in such a way that exposure of patients,
users, and other persons to radiation shall be reduced as far as possible compatible with the intended
purpose, while not restricting the application of appropriate specified levels for therapeutic and
diagnostic purposes.
ER 11.2. Intended radiation

ER 11.2.1 Where devices are designed to emit hazardous levels of radiation necessary for a specific
medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it
must be possible for the user to control the emissions. Such devices shall be designed and
manufactured to ensure reproducibility and tolerance of relevant variable parameters.
ER 11.2.2. Where devices are intended to emit potentially hazardous, visible and/or invisible
radiation, they must be fitted, where practicable, with visual displays and/or audible warnings of such
emissions.
ER 11.3. Unintended radiation

ER.11.3.1. Devices shall be designed and manufactured in such a way that exposure of patients, users
and other persons to the emissions of unintended, stray or scattered radiation is reduced as far as
possible.
ER 11.4. Instructions
ER 11.4.1. The operating instructions for devices emitting radiation must give detailed information as
to the nature of the emitted radiation, means of protecting the patient and the user and on ways of
avoiding misuse and of eliminating the risks inherent in installation.
ER 11.5. Ionising radiation

ER 11.5.1. Devices intended to emit ionising radiation must be designed and manufactured in such a
way as to ensure that, where practicable, the quantity, geometry and quality of radiation emitted can
be varied and controlled taking into account the intended use.

CONFIDENTIAL

Does ER apply
ER 11.5.2. Devices emitting ionising radiation intended for diagnostic radiology shall be designed and
manufactured in such a way as to achieve appropriate image and/or output quality for the intended
medical purpose whilst minimising radiation exposure of the patient and user.
ER 12. Requirements for devices connected to or equipped with an energy source

ER 12.1. Devices incorporating electronic programmable systems must be designed to ensure the
repeatability, reliability, and performance of these systems according to the intended use. In the
event of a single fault condition (in the system) appropriate means should be adopted to eliminate or
reduce as far as possible consequent risks.
ER 12.1a. For devices which incorporate software or which are medical software in themselves, the
software must be validated according to the state-of-the-art taking into the account the principles of
development lifecycle, risk management, validation and verification.
ER 12.2. Devices where the safety of the patients depends on an internal power supply must be
equipped with a means of determining the state of the power supply.
ER 12.3. Devices where the safety of the patients depends on an external power supply must include
an alarm system to signal any power failure.
ER 12.4. Devices intended to monitor one or more clinical parameters of a patient must be equipped
with appropriate alarm systems to alert the user of situations which could lead to death or severe
deterioration of the patient’s state of health.
ER 12.5. Devices must be designed and manufactured in such a way as to minimise the risks of
creating electromagnetic fields which could impair the operation of other devices or equipment in the
usual environment.
ER 12.6. Protection against electrical risks:

Devices must be designed and manufactured in such a way as to avoid, as far as possible, the risk of
accidental electric shocks during normal use and in single fault condition, provided the devices are
installed correctly.
ER 12.7. Protection against mechanical and thermal risks

ER 12.7.1. Devices must be designed and manufactured in such a way as to protect the patient and
user against mechanical risks connected with, for example, resistance, stability and moving parts.

CONFIDENTIAL

Does ER apply
ER 12.7.2. Devices must be designed and manufactured in such a way as to reduce to the lowest
possible level the risks arising from vibration generated by the devices, taking account of technical
progress and of the means available for limiting vibrations, particularly at source, unless the
vibrations are part of the specified performance.
ER 12.7.3. Devices must be designed and manufactured in such a way as to reduce to the lowest
possible level the risks arising from the noise emitted, taking account of technical progress and of the
means available to reduce noise, particularly at source, unless the noise emitted is part of the
specified. Performance.
ER 12.7.4. Terminals and connectors to the electricity, gas or hydraulic and pneumatic energy supplies
which the user has to handle must be designed and constructed in such a way as to minimise all
possible risks.
ER 12.7.5. Accessible parts of the devices (excluding the parts or areas intended to supply heat or
reach given temperatures) and their surroundings must not attain potentially dangerous
temperatures under normal use.
ER 12.8. Protection against the risks posed to the patient by energy supplies or substances
ER 12.8.1. Devices for supplying the patient with energy or substances must be designed and
constructed in such a way that the flow-rate can be set and maintained accurately enough to
guarantee the safety of the patient and of the user.
ER 12.8.2. Devices must be fitted with the means of preventing and/or indicating any inadequacies in
the flow-rate which could pose a danger. Devices must incorporate suitable means to prevent, as far
as possible, the accidental release of dangerous levels of energy from an energy and/or substance
source.
ER 12.9. The function of the controls and indicators must be clearly specifiedon the devices. Where a
device bears instructions required for its operation or indicates operating or adjustment parameters
by means of a visual system, such information must be understandable to the user and, as
appropriate, to the patient.
ER 13. Information supplied by the manufacturer


CONFIDENTIAL

Does ER apply
ER 13.1. Each device must be accompanied by the information needed to use it safely and properly,
taking account of the training and knowledge of the potential users, and to identify the manufacturer.
This information comprises the details on the label and the data in the instruction for use. As far as
practicable and appropriate, the information needed to use the device safely must be set out on the
device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If
individual packaging of each unit is not practicable, the information must be set out in the leaflet
supplied with one or more devices. Instructions for use must be included in the packaging for every
device. By way of exception, no such instructions for use are needed for devices in Class I or IIa if they
can be used completely safely without any such instructions.
ER 13.2. Where appropriate, this information should take the form of symbols. Any symbol or
identification color used must conform to the harmonised standards. In areas for which no standards
exist the symbols and colors must be described in the documentation supplied with the device.
ER 13.3. The label must bear the following particulars:
ER 13.3 (a). The name or trade name and address of the manufacturer. For devices imported into the
community, in view of their distribution in the community, the label, or the outer packaging, or
instructions for use, shall contain, in addition, the name and address of the authorised representative
where the manufacturer does not have a registered place of business in the community.
ER 13.3 (b). The details strictly necessary to identify the device and the contents of the packaging
especially for the users.
ER 13.3 (c ). Where appropriate, the word ‘STERILE’.
ER 13.3 (d). Where appropriate, the batch code, preceded by the word ‘LOT’, or the serial number.
ER 13.3 (e ). Where appropriate, an indication of the date by which the device should be used, in
safety, expressed as the year and month.
ER 13.3 (f). Information regarding the risks of reciprocal interference posed by the presence of the
device during specific investigations or treatment.
ER 13.3 (g). The necessary instructions in the event of damage to the sterile packaging and, where
appropriate, details of appropriate methods of re-sterilisation.

CONFIDENTIAL

Does ER apply
ER 13.3 (h). If the device is reusable, information on the appropriate processes to allow reuse,
including cleaning, disinfection, packaging and, where appropriate, the method of sterilisation of the
device to be re-sterilised, and any restriction on the number of reuses. Where devices are supplied
with the intention that they be sterilised before use, the instructions for cleaning and sterilisation
must be such that, if correctly followed, the device will still comply with the requirements in Section I.
If the device bears an indication that the device is for single use, information on known characteristics
and technical factors known to the manufacturer that could pose a risk if the device would be re-
used. If in accordance with Section 13.1 no instructions for use are needed, the information must be
made available to the user upon request.
ER 13.3 (i). Details of any further treatment or handling needed before the device can be used (for
example, sterilisation, final assembly, etc.).
ER 13.3 (j). in the cases of devices emitting radiation for medical purposes, details of the nature, type,
intensity and distribution of this radiation.
The instructions for use must also include details allowing the medical staff to brief the patient on any
contraindications and any precautions to be taken. These details should cover in particular:
ER 13.3 (k). Precautions to be taken in the event of changes in the performance of the device.
ER 13.3 (l). Precautions to be taken as regards exposure, in reasonably foreseeable environmental

conditions, to magnetic fields, external electrical influences, electrostatic discharge, pressure or
variations in pressure or acceleration, thermal ignition sources, etc.
ER 13.3 (m). Adequate information regarding the medicinal product or products which the device in
question is designed to administer, including any limitations in the choice of substances to be
delivered
ER 13.3 (n). Precautions to be taken against any special, unusual risks related to the disposal of the
device.
ER 13.3 (o). Medicinal substances, or human blood derivatives incorporated into the device as an
integral part in accordance with section 7.4.
ER 13.3 (p). Degree of accuracy claimed for devices with a measuring function.

CONFIDENTIAL

Does ER apply
ER 13.3 (p). Date of issue or the latest revision of the instructions for use.

Equalance Comparission Data

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Equalance Comparission Data

Uploaded by

Copyright:

Available Formats

Clinical Evaluation Report (CER) for <Device name>

1. DO NOT UNDERESTIMATE THE PRESCRIBED CHALLENGES OF INDUSTRY QUALITY AND REGULATORY

ROUGH CER TEMPLATE WELCOME AND TIPS.

THERE IS NO REGULATORY MANDATE TO USE THIS TEMPLATE.

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

1. DO NOT UNDERESTIMATE THE PRESCRIBED CHALLENGES OF INDUSTRY QUALITY AND REGULATORY

Directives, guidelines and standards:

Databases for clinical trials, surveillance and literature reviews:

- European Commission EUDAMED - https://ec.europa.eu/health/md_eudamed/overview_en

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

- Cochrane Central Register of Controlled Trials (CENTRAL) -

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

Clinical evaluation report (CER) for <Device name> 08 Apr 2020

DOCUMENT HISTORY 04 Aug 2020

Document No Version Date Details of document change

- Section X.X had the following sub-headings

No need to provide reasons for changes to the

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

The CER outline:

<MDCG 2020-13 scope applies to:

This CER contains information on:

Remove or add as applicable

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

Recipient: Department: Biostatistics

Recipient: Department: Clinical operations

Recipient: Department: Engineering

Recipient: Department: Marketing

Recipient: Department: Materials Science and Technology (MSAT)

Recipient: Department: Medical Affairs

Recipient: Department: Medical Consultant

Recipient: Department: Medical Writing

Recipient: Department: Production

Recipient: Department: Quality Assurance

Recipient: Department: Regulatory Affairs

Recipient: Department: More or less depending on your process.

Approved by: Title: Biostatistics Signed: Date:

Approved by: Title: Clinical operations Signed: Date:

Approved by: Title: Engineering Signed: Date:

Approved by: Title: Marketing Signed: Date:

Approved by: Title: MSAT Signed: Date:

Approved by: Title: Medical Affairs Signed: Date:

Approved by: Title: Medical Consultant Signed: Date:

Approved by: Title: Medical Writing Signed: Date:

Approved by: Title: Production Signed: Date:

Approved by: Title: Quality Assurance Signed: Date:

Approved by: Title: Regulatory Affairs Signed: Date:

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

ACRONYMS AND DEFINITIONS LIST

CEAR Clinical Evaluation Assessment Report

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

No table of figures entries found.

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

c) Notified body particulars:

d) This report satisfies notified body assessment for:

e) Intended purpose description

f) Clinical evaluation report authors list

g) Notified body general and specific assessment considerations covered

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

Jennifer Bell, PhD: https://www.linkedin.com/in/jennifermlbell/

DOCUMENT HISTORY ..................................................................................................................................... i