Medical Devices 
Medical Devices Coordination Group Document                                            MDCG  2020-13         
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MDCG 2020-13 
  
Clinical evaluation assessment report template   
 
July 2020 
 
 
  
 
This document has been endorsed by the Medical Device Coordination Group (MDCG) established 
by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and a representative of the European Commission chairs it. The document is not a European Commission document and it cannot be regarded as reflecting the official position of the European Commission. Any views expressed in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law. 
  Medical Devices 
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Contents 
 
Introduction ............................................................................................................................... ....... 3  
Scope ......................................................................................................................... ..................... 3  
Approach to Template .......................................................................................................... ........... 4  
Template CEAR ................................................................................................................. ............. 6  
Section A: Administrative particulars (notified body, manufacturer, product and clinical 
evaluation report reference) .................................................................................................. ....... 6  
Section B: Reviewers involved in the notified body assessment of the clinical evaluation ........... 7  
Section C: Device description, classification, clinical evaluation plan, information materials 
supplied by the manufacturer, common specifications and harmonised standards applied, equivalence and state of the art .............................................................................................. ..... 8
 
Section D: Clinical literature review.......................................................................................... .. 15  
Section E: Clinical investigations and related documentation .................................................... 18  
Section F: PMS, PMCF and the plan for updates ...................................................................... 20  
Section G: IFU, SSCP, labelling and other information supplied with the device ....................... 21  
Overall Conc lusions: .......................................................................................................... ........ 24  
Specific Considerations ....................................................................................................... .......... 25  
Section I: Clinical evaluation c onsultation procedure for certain class III and class IIb devices 
(Article 54) .................................................................................................................. ............... 25  
Section J: Where demonstration of conformity based on clinical data is not deemed appropriate 
(Article 61(10)) .............................................................................................................. ............. 28  
Section K: The voluntary clinical consultation on the clinical development strategy (Article 61(2))
 .............................................................................................................................. ..................... 30  
 
 
  Medical Devices 
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List of acronyms 
CEAR   Clinical Evaluation Assessment Report 
CECP   Clinical Evaluation Consultation Procedure CER   Clinical Evaluation Report CIP   Clinical Investigation Plan EUDAMED  European Databank on Medical Devices IFU   Instructions for Use MDR   Medical Device Regulation (Regulation (EU) 2017/745 on me dical devices) 
PMCF   Post-Market Clinical Follow-up PMS   Post-Market Surveillance PSUR   Post-Market Surveillance Update Report 
SRN   Single Registration Number 
SSCP   Summary of Safety and Clinical Performance  TDAR   Technical Documentation Assessment Report  UDI-DI   Unique Device Identification Device Identifier 
  Medical Devices 
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 Introduction  
A  c l i n i c a l  e v a l u a t i o n  a s s e s s m e n t  r e p o r t  ( C E A R )  i s  a  r e p o r t  u s e d  b y  t h e  n o t i f i e d  b o d y  t o  c l e a r l y  d o c u m e n t  t h e  
conclusions of its assessment of the clinical evidence presente d by the manufacturer in the clinical evaluation report 
(CER) and the related clinical evaluation that was conducted – a core requirement of the Medical Device Regulation 
(EU) 2017/745 (MDR).   The clinical evaluation must be a part of the manufacturer's qu ality management. It should also be aligned with and 
reflected in other aspects of the technical documentation, such  as: 
• The interface of the clinical eva luation with the risk manageme nt process and its appraisal and analysis of the pre-
clinical and clinical evaluation and their relevance for the de m o n s t r a t i o n  o f  c o n f o r m i t y  w i t h  t h e  r e l e v a n t  
requirements in Annex I.
1 
• Post-market surveillance including  any corrective and preventiv e actions involving the device. 
• Post-market clinical follow-up pl an and where appropriate the p ost-market clinical follow-up report. 
• Instructions for use, which provide adequate information on int ended purpose, proper use and warnings about 
risks to patients and healthcare practitioners. 
 As part of its conformity assessment activities the notified bo dy shall examine, validate and verify that manufacturers' 
procedures and documentation adequately address the requirement s relating to the technical documentation
2 and 
clearly document its assessment3.  
 
The notified body shall review the clinical evidence presented by the manufacturer in the clinical evaluation report 
and the related clinical evaluation that was conducted, which i ncludes4:  
 
 Assessing the suitability of using data from claimed equivalent  devices, taking into account factors such as new 
indications and innovation. The notified body shall clearly doc ument its conclusions on the claimed equivalence, 
and on the relevance and adequacy of the data for demonstrating  conformity. For any characteristic of the device 
claimed as innovative by the manufacturer or for new indication s, the notified body shall assess to what extent 
specific claims are supported by specific pre-clinical and clin ical data and risk analysis. 
 Verifying that the clinical evidence and the clinical evaluatio n are adequate and shall verify the conclusions drawn 
by the manufacturer on the conformity with the relevant general  safety and performance requirements. That 
verification shall include consideration of the adequacy of the  benefit-risk determination, the risk management, 
the instructions for use, the user training and the manufacture r's post-market surveillance plan, and include a 
review of the need for, and the adequacy of, the PMCF plan prop osed, where applicable. 
 Considering the clinical evaluation and the benefit-risk determ ination, and whether specific milestones need to be 
defined to allow the notified body to review updates to the cli nical evidence that result from post-market 
surveillance and PMCF data.   
 The outcome of this assessment must be clearly documented in th e CEAR.
5 A harmonised CEAR template provides a 
standardised method for documenting the notified body’s assessm ent of the manufacturer’s clinical evaluation and 
related documents. CEARs in this format will also support specific additional requirements  such as the clinical 
evaluation consultation procedure6 and reviews by designating authorities.7  
Scope 
This template applies to MDR Annexes IX section 4 and Annex X s ection 3. It also applies to assessments of technical 
documentations on a sampling basis for class IIa/IIb devices in  accordance with Annex IX sections 2.3 and 3.5 and 
                                            
1 MDR, Annex VII Section 4.5.1 and 4.5.5 
2 MDR, Annexes II and III 
3 MDR Annex VII Section 4.5.5 and 4.6  
4 MDR, Annex IX Sections 4.4 to 4.7  
5 MDR, Annex IX 4.8   
6 MDR, Article 54 
7 MDR, Article 45 Medical Devices 
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 Section 10 of Annex XI(A).8 Aspects related to the clinical evaluation assessment are also  laid down in Section 4.5.5 
an d  oth er r ele van t s ecti on s of A n n e x V II.   It als o ap p lies to  m ed ical d e vice s fo r wh ich  clin ical d at a is n o t  d ee med  
appropriate,9 to demonstrate conformity with Annex I, and the demonstration of an adequate justification for this.10 
Approach to Template 
Please note that the explanatory text under each heading provid es brief descriptions of the type of information which 
will be included by the  notified body, however it is not an all -inclusive list and further detail may be required depending 
upon the device or the intended purpose for which it will be us ed. This template represents the minimum  content  for 
a CEAR and needs to be incorporated into the process and proced ures of the notified body.11 The CEAR shall also make 
a recommendation to support a final review and a final decision  to be taken by the notified body.  
 
Any non-compliances identified during the assessment of the asp ects described in the relevant sections of the 
template, as well as the appropriate follow up actions taken by  the manufacturer to close them need to be 
documented. This template may be used by the notified body to d ocument the non-compliance/deficiencies and 
queries raised during the assessment and the assessment of resp onses received. It is important to note that the 
completed CEAR may not necessarily contain comprehensive inform ation regarding the non-compliance/deficiencies, 
which were raised by the notifie d body during the course of the  assessment. The CEAR shall document the outcome12 
and the conclusions13 of the assessment.  
 Designating authorities shall assess whether the clinical evalu ation assessment was conducted appropriately, 
considering the assessment, procedures, associated documentatio n and the conclusions;
14 Designating authorities will 
have access to the complete ‘audit trail’ of the notified body.   
 
Expert panels who are conducting a clinical evaluation consulta tion procedure shall assess the CEAR, however they 
may not have access to the complete conformity assessment for t he device and associated procedures and 
documentation. To enable the expert panel work, the CEAR shall provide sufficient information with respect to the 
clinical evidence provided by the manufacturer, in particular c oncerning the benefit-risk determination, the 
consistency of that evidence with the intended purpose, includi ng the medical indication or indications and the PMCF 
plan.15 Expert panels may also request the notified body to present it s conclusions regarding the clinical evaluation 
assessment report.16  
 
It is only once all the non-compliances have been closed out th at the relevant tick-box should be completed to signal 
t h a t  t h e  a s s e s s m e n t  i s  p o s i t i v e .  I n  t h e  r a r e  e v e n t  t h a t  t h e r e  i s one or more open minor non-compliances at the 
conclusion of the assessment stage, this must be clearly descri bed in the template, together with appropriate follow-
u p  a c t i o n s  t o  c l o s e  t h e m ,  a n d  e x p e c t e d  c o m p l e t i o n  t i m e l i n e s  t o  be followed by the manufacturer under the 
supervision of the notified body.  
 
The sections covered in Annex I of this template are generally applicable depending on the type of assessment. The 
sections covered in Annex II may be applicable, depending upon the device under evaluation. All applicable sections 
should be completed, relevant conclusions reached and correspon ding boxes ticked for the report to be complete . 
The CEAR should be signed-off by the relevant personnel in acco rdance with the quality management system of the 
notified body. When making available the CEAR to third parties,  the notified body should treat the personal data within 
                                            
8 MDCG 2019-13  
9 Article 61(10) 
10 Based on the results of the manufacturer's risk management and  on consideration of the specifics of the interaction between 
the device and the human body, the clinical performance intende d and the claims of the manufacturer. 
11 MDR, Annex VII Section 4.6  
12 MDR, Annex IX Section 4.8 
13 MDR, Annex VII Section 4.6 
14 MDR, Article 45(3) 
15 MDR, Annex IX Section 5.1(c) 
16 MDR, Annex IX Section 5.1(b)  Medical Devices 
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 it as per its procedures for the management of personal data, i n compliance with Regulation (EU) 2016/679 General 
Data Protection Regulation.  
 
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 Template CEAR 
 
Section A: Administrative particulars (notified body, manufactu rer, product and clinical evaluation report reference)  
Medical device name model and type:  
☐ Basic UDI-DI(s) (if available): 
 
☐ Certificate number (if applicable): 
 Project number:  Risk Class:  
 
Applicable code(s) per Commission Implementing 
Regulation (EU) 2017/2185: 
 Manufacturer(s) name and SRN:
  
 Authorised representative (if applicable) 
name and SRN: 
 
  Notified body:  
 Notified body number:  
 
E-mail contact of NB: 
 Telephone contact of NB:   
 Parts of this template which have been 
applied 
 
General considerations
17 
☐ Section A: Administrative particulars  
☐ Section B: Reviewers involved  
☐ Section C: Device description, 
classification, clinical evaluation plan, 
information materials supplied by the 
manufacturer, common specifications and harmonised standards applied, equivalence and state of the art 
☐ Section D: Clinical literature review 
☐ Section E: Clinical investigations and 
related documentation 
☐ Section F: PMS and PMCF 
☐ Section G: IFU, SSCP, labelling and other 
information supplied with the device 
☐ Section H: Summary of all available data 
and conclusions 
☐ Overall Conclusions 
 
Specific Considerations Type of assessment:  
☐ Initial conformity assessment  
☐ Assessment of changes18 and update of the clinical 
evaluation19 
☐ Re-certification assessment 
☐ Assessment of technical documentation for class IIa 
/ IIb devices on a sampling basis 
 Intended purpose: 
 Check of clinical evaluation report authors 
☐ CER dated and signed 
☐ CVs provided for CER author(s) 
 
Comments: 
Confirm CVs are up to date 
Confirm CER authors have full range of 
required expertise represented (e.g. research methods, information 
                                            
17 These must be completed in all cases 
18 MDR, Annex IX Section 4.10 
19 For example in accordance with Annex VII, Section 4(10) Medical Devices 
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 According to Annex / section:   
Insert the Annex and section  management, regulatory requirements, 
device technology, diagnosis and 
management of conditions to be treated) 
CVs are considered acceptable: ☐ 
 ☐ Section I: Clinical evaluation 
consultation procedure for certain class III and class IIb devices (Article 54) 
☐ Section J: Where demonstration of 
conformity based on clinical data is not deemed appropriate (Article 61(10)) 
☐ Section K: The voluntary clinical 
consultation on the clinical development strategy (Article 61(2)) 
Technical file identification number and technical documentatio n assessment report (TDAR) reference if available or any other references that allow the correlation between TDAR and 
CEAR: 
 
Documents assessed: 
For example, clinical evaluation report, clinical investigation  plan, clinical investigation re port, ethics committee approval , Competent Authority approval, post market surveillance data, 
publications. 
Include the title, version number/reference and date of the doc uments.  
When the CER has been updated verify that this update correspon ds to the most recently updated PMS/PMCF reports and any condit ions set on the first certification, if applicable. 
Note that references to the technical documentation should be m ade in order to ensure document control. 
 
 
 
Section B: Reviewers involved in the notified body assessment o f the clinical evaluation  
Provide the name or the employee code of the personnel with rel evant clinical expertise (as  per 3.2.4 of annex VII): 
 
Relevant clinical expertise:  
 
Have additional reviewers been involved? Medical Devices 
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 ☐Yes 
☐No  
Provide a justification: 
 
Additional reviewers assigned to review the clinical evaluation  
Number of additional reviewers 
Names of additional reviewers: 
Separate the internal and external clinical 
reviewers. 
You may use employee codes 
 Specific aspects assessed (by each additional reviewer): For example, rationale 
for the design and chosen statistical methodology of clinical i nvestigation etc.  Competence area / codes: List of relevant MDR codes 
or area this person is authorised to, according to the 
Authorisation Matrix, as of Annex VII, 3.3.2)  
Relevant expertise:  
 
 
 
Section C: Device description, classification, clinical evaluat ion plan, information materials supplied by the manufacturer, c ommon specifications and harmonised standards applied, 
equivalence and state of the art 
Device description  
Describe the device and comment on the intended purpose, includ ing:  
 The intended patient population and medical conditions to be di agnosed, treated and/or monitored.  
 A general description of the key functional elements: its parts /components (including software if appropriate), its formulatio n, its composition, its functionality and, where relevant, 
its qualitative and quantitative composition.  
 The principles of operation of the device and its mode of actio n; explanation of any novel features. 
 
Classification 
List the applicable classifica tion rule(s) and indents. 
 Medical Devices 
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 Device configurations/variants included in this application: 
Include the manufacturers description of the sizes, differences  in design features, different configurations etc.  
Include an image of the device where possible.  
If applicable, include the manufacturers description of the dev ice history and/or changes in the device since its last assessm ent. 
Where relevant, include the manufacturers description of the re ason for differences in design variants with illu strative image s where possible. 
 
Accessories or compatible devices: Describe any accessories or compatible devices if any or state,  “none”). 
Include component devices in case of system/procedure pack. If the use of accessories or compatible devices has an impact o n clinical safety or performance or the scope or validity of th e clinical evaluation,  identify this here.  
If it is necessary to understand the usage of the device, inclu de images or other relevant inf ormation such as diagrams. 
 
Previous generations of the device and similar devices (if appl icable):  
Verify that the manufacturer has provided:  
 an overview of the previous generation or generations of the de vice produced by the manufacturer, where such devices exist. 
 an overview of identified similar  devices available on the Unio n or international markets, where such devices exist, including  length of time on the market, sales volume etc. 
Non-compliances identified and resolved for this section may be  briefly described in this box 
Device details, intended purpose and classification are:  
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
Clinical evaluation plan Medical Devices 
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 Briefly summarise the manufacture r’s clinical evaluation plan a nd confirm that it meets the requirements of Annex XIV Part A S ection 1a, highlighting the areas which require particular 
attention for this assessment: 
 an identification of the general safety and performance require ments that require support from relevant clinical data; 
 a specification of the intended purpose of the device;  
 a clear specification of intended target groups with clear indi cations and contra-indications;  
 a detailed description of intended clinical benefits to patient s with relevant and specified clinical outcome parameters;  
 a specification of methods to be used for examination of qualit ative and quantitative aspects of  clinical safety with clear re ference to the determination of residual risks and side-
effects;  
 an indicative list and specification of parameters to be used t o determine, based on the state of the art in medicine, the acc eptability of the benefit-risk ratio for the various indication s 
and for the intended purpose or purposes of the device;  
 an indication  how benefit-risk issues relating to specific components such a s use of pharmaceutical, non-viable animal or human tissues, ar e to be addressed; and  
 a clinical development plan indi cating progression from explora tory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmat ory investigations, such as 
pivotal clinical investigations, and a PMCF as referred to in P art B of Annex XIV of MDR, with an indication of milestones and  a description of potential acceptance criteria. 
A detailed description of the clinical development plan is not required for the purpose of this template unless there are spec ific concerns.  
Add the manufacturer’s reference and version and date of the cl inical evaluation plan. 
Clinical performance 
Summarise the clinical data to d emonstrate the ability of the d evice, resulting from any direc t or indirect medical effects wh ich stem from its technical or functional characteristics, incl uding 
diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical bene fit for patients, when used as intended by the manufacturer. 
Describe the clinical benefits. 
Safety 
Does the clinical evaluation adequately addresses the qualitati ve and quantitative aspects of clinical safety with clear refer ence to the determination of residual risks and undesirable sid e-
effects and the confirmation of the relevant safety and perform ance requirements provided for in Annex I? 
Summarise the clinical data regarding safety, and also describe  residual risks and any undesirable side- effects. 
Does the clinical evaluation spec ify the methods to be used for  examination of qualitative and quantitative aspects of clinica l safety with clear reference to the determination of residual risks 
and undesirable side-effects? 
If relevant, briefly summarise any  significant complaint, trend s or vigilance issues associated w ith earlier device iterations , which may be equivalent or similar devices, and explain wheth er 
or not they have any impact on the clinical evaluation assessme nt. 
Non-compliances identified and resolved for this section may be  briefly described in this box Medical Devices 
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 The clinical evaluation plan is: 
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
Common specifications, harmonised standards or other solutions applied 
Are there common specifications relevant to the device under ev aluation? 
Have they been complied with? If not:
20  
 Explain any deviations and how t hese might affect the validity of the clinical evaluation and its conclusions, and any equival ence claims. 
 Confirm that the manufacturer has adopted solutions that ensure  a level of safety and performanc e that is at least equivalent thereto in accordance with Article 9(3). 
 
Are there harmonised standards relevant to the clinical evaluat ion of the device under evaluation? 
Have they been applied? If partially applied add the manufacturers justification and co nfirm that the manufacturer has adopted solutions that ensure a  level of safety and performanc e required by the Regulation 
(EU) 2017/745. 
If there are deviations explai n any deviations and how these mi ght affect the validity of the clinical evaluation and its conc lusions, and any equivalence claims. 
Is the most up-to-date revision being used by the manufacturer?  (state which revision was used) 
 
Are there other solutions that have been applied? 
Describe any standards, guidance or other solutions that have b een applied, and the manufacturers justification  
Non-compliances identified and resolved for this section may be  briefly described in this box 
                                            
20 Excluding devices listed in Annex  XVI which must comply with th e relevant common specifications  in accordance with Article 9(4 ). Medical Devices 
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 The application of CS, harmonised standards or other solutions is:  
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
The demonstration of equivalence 
Is the clinical evaluation based upon clinical investigation(s)  or other studies reported in scientific literature, of a devic e for which equivalence to the device in question can be 
demonstrated? 
State Yes / No Device(s) to which equivalence has been claimed: 
 
Is the clinical evaluation based upon reports published in peer  reviewed scientific literature on a device for which equivalen ce to the device in question can be demonstrated?  
State Yes / No 
If yes, specify the source(s) of the data, if it is the device in question, or an equivalent device, or both. 
 
Device(s) to which equivalence has been claimed:  
 
Device which is most relevant: 
 
Assessment of equivalence 
1. Equivalence rationales: 
Indicate which devices are/are not equivalent, and confirm that  data relating to devices which are not equivalent have been ex cluded from the analysis of clinical data for the purposes for 
demonstrating safety and performance. 
 
If equivalence has been claimed to more than one device, each d emonstration of equivalence can only be based on a single devic e. Each equivalent device must meet all three equivalence 
criteria (clinical, technical, biological). 
 
2. Are the devices equivalent in accordance with Section 3 of Anne x XIV including technical, biologi cal and clinical characterist ics? 
State Yes / No 
Identify any differences in these parameters, and verify why th ese are not expected to adversely affect the safety and perform ance of the medical device under evaluation. Medical Devices 
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 Non-compliances identified and resolved for this section may be  briefly described in this box 
The demonstration of equivalence is:  
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
Access to data  
Comment on the manufacturer’s access to data, relating to devic es with which they are claiming equivalence in order to justify  their claims of equivalence. 
For implantable and Class III device s, if equivalence is claime d with a device marketed by another manufacturer, confirm that there is a current valid contract between the two 
manufacturers allowing ongoing access to the technical document ation in accordance with Article 61 (5) of the MDR. 
Has the original clinical evaluat ion been performed in complian ce with the requirements of Regulation 2017/745, and has the ma nufacturer of the second device provided clear evidence 
thereof? 
 State Yes / No  
Confirm that access to data is sufficient to provide the manufa cturer with enough information about the equivalent devices to support equivalence claims, in cluding any testing which may 
have been undertaken to confirm equivalence of specifications/p erformance/etc.  
 
Any other limitations with re spect to equivalent devices: 
Comment on any other limitations with respect to the equivalent  devices or manufacturer’s equivalence claims, and the extent t o which these limitations impact the manufacturer’s clinical 
evaluation and conclusions. 
 
Non-compliances identified and resolved for this section may be  briefly described in this box 
Manufacturer demonstration of equivalence and access to data is : 
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ Medical Devices 
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Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
State of the art 
Benchmark devices, state of the art and other available treatme nt options: 
Describe the alternative availabl e treatment options identified  by the manufacturer which could offer comparable safety and pe rformance for the same treatment indications / patient 
populations, etc. 
 
Briefly describe how benchmarks for safety and performance have  been identified by the manufacturer in terms of the state of t he art. Benchmarks will norma lly be based on aggregate data 
from several devices considered to have acceptable performance (e.g. systematic reviews or registry analysis); if individual d evices are selected as benchmarks for safety and performance, a  
suitable rationale should be provided. 
 Confirm that the manufacturer's description of the state of the  art is based upon an appropriate literature search (see sectio n D)?  
 
For devices previously marketed, is the description of the stat e of the art still accurate? Can the device still be considered  to be state of the art? 
 Safety, performance and benefit-risk claims - requirements in t erms of the state of the art: 
What performance and safety endpoints has the manufacturer iden tified? 
In light of the outcomes achievable with benchmark products and  other treatment options, are these endpoints appropriate and c linically relevant? Have surrogate endpoints been 
adequately justified? 
 
Has the manufacturer adequately described an indicative list an d specification of parameters used to determine, based on the s tate of the art in medicine, the  acceptability of the benefit-
risk ratio for the various indications and for the intended pur pose or purposes of the device? 
 
Non-compliances identified and resolved for this section may be  briefly described in this box 
Manufacturer demonstration of state of the art is: 
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ Medical Devices 
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Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
Novelty 
Include the manufacturer’s explanation of any novel features of  the device and/or the related  clinical procedures and their pu rpose.  
What is the possible clinical or health impact in terms of bene fit/risk? 
Is novelty adequately addressed? ☐ 
 
 
Section D: Clinical literature review  
With respect to the search criteria  of the literature review, does it: 
☐ Address all device sizes, variants, model and accessories? 
☐ Address the same clinical condition? 
Further information regarding literature search methods is avai lable in MEDDEV 2.7/1 revision 4, section A5. 
Searches for the device in question, equivalent devices and oth er devices (for example to support a description of the state o f the art) should be described separately. 
 With respect to the selection criteria  of the literature review, does it relate to both below: 
☐ The device under evaluation or to a device demonstrated to be equivalent? 
☐ The state of the art or alternative available treatment option ? 
The clinical evaluation should c learly describe the selection c riteria with respect to the regulatory purpose to which it will  apply. The CER should clearly differentiate between the two ty pes 
of data referenced above. If the data does not relate to either  of the above, provide a rationale with respect to its inclusio n.  
 
Literature search protocol21 
Provide a brief summary of the literature search strategy appli ed, commenting on: 
                                            
21 For general guidance on a literat ure search, see MEDDEV 2.7/1 r evision 4, A5. Literature search and literature review protocol , key elements.  Medical Devices 
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 • The adequacy of search terms: for example, it should be suffici ently broad to establish benchmarks, determine the general stat e of the art, determine potential risk, adverse 
events, undesirable side-effects, etc.  
Note that a search which is restricted to the manufacturer’s ow n product or the name of their chosen equivalent could miss imp ortant information and therefore is not 
acceptable. 
• Databases used (to minimize bias multiple databases should be u sed). 
• Acceptability of inclusion and exclusion criteria.  
• Both favourable and unfavourable data included. 
• Strategies for avoiding duplication of data (for example, acros s different publications or between manufacturer and published data). 
• Literature search and review protocol (i.e. how did the manufac turer test this protocol to ensure comprehensive identification  of relevant data / demonstrate that all relevant 
data has been retrieved?). 
• Any deviations from the manufacturer’s literature search protoc ol. 
• Overall conclusions regarding the adequacy of search methods, l ikelihood of having retrieved all relevant data, and methods us ed to avoid bias. 
Comment if systematic search and review methods such as the fol lowing have been used: 
• PICO (patient characteristics, type of intervention, control, a nd outcome queries). 
• Cochrane Handbook for Systematic Reviews of Interventions. 
• PRISMA (The Preferred Reporting Items for Systematic Reviews an d Meta-Analyses) Statement. 
• MOOSE Proposal (Meta-analysis Of Observational Studies in Epide miology). 
• Other (specify or describe). 
Literature searc h documentation: 
☐ Literature search protocol provided 
☐ Literature search reports provided 
☐ Full list of retrieved articles provided 
☐ Full list of excluded articles provided, with reasons for excl usion 
☐ Full text copies of relevant documents available 
 Comments: 
Provide rationale if any of the above has not been provided. Medical Devices 
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 Nota bene: 
• A literature search and other retrieval of data should be carri ed out based on a search protocol. The search protocol should d ocument the planning of the search before execution.  
• Once the searches have been executed, the adequacy of the searc hes should be verified and a literature search report should be  compiled to present details of the execution, any 
deviations from the literature search protocol, and the results  of the search. 
• It is important that the literature search is documented to suc h degree that the methods can be appraised critically, the resu lts can be verified, and the search reproduced if 
necessary. 
• Abstracts lack sufficient detail to allow issues to be evaluate d thoroughly and independently, but may be sufficient to allow a first evaluation of the relevance of a paper. Copies of 
the full text papers and documents should be obtained for the a ppraisal stage. 
• The literature search protocol(s), the literature search report (s), and full text copies of relevant documents using URL links , become part of the clinical evidence and, in turn, the 
technical documentation for the medical device. 
Non-compliances identified and resolved for this section may be  briefly described in this box  
Literature search protocol and outputs are: 
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
Data appraisal: 
Provide a brief summary of the manufacturer’s data appraisal me thods (i.e. how they determine whether the data from a given st udy or other source of data is of sufficient quality and 
relevance to be included in the clinical evaluation. This inclu des evaluation of criteria incl uding study design, sources of b ias, peer review, relevance to subject device, etc. Retrieved s tudies 
and data sets should be weighted on the basis of scientific qua lity and relevance to the scope and objectives of the clinical evaluation for the subject devices). 
Justify the acceptability of the appraisal in terms of: 
• Methodological quality and scient ific validity of articles retr ieved and evaluated appropriately. 
• Relevance of the information to the clinical evaluation determi ned and documented. 
• Contribution of each data set to the clinical evaluation weight ed according to systematic criteria. Medical Devices 
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Non-compliances identified and resolved for this section may be  briefly described in this box  
Data appraisal is:  
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer.  
 
 
Section E: Clinical investigations and related documentation  
Has the manufacturer conducted clinical investigation(s)?  
State Yes / No 
 Has the manufacturer conducted pre-market or post-market clinic al investigations? 
Provide detail 
 If the manufacturer has not conducted clinical investigation: What is the rationale?  
Why is this acceptable / unacceptable? 
 Has the manufacturer provided a c opy of all clinical investigat ion reports? 
State Yes / No 
 
Were all clinical investiga tions publicly registered? 
State Yes / No 
 
Have been verified that clinical investigations conducted with respect to Regulation (EU) 745/ 2017 publicly registered on EUDA MED? 
State Yes / No Provide the EUDAMED single regist ration number where available.  Medical Devices 
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Did the clinical investigations result in a publication in a sc ientific journal? 
State Yes / No If yes, does the clinical investigation report reflect the resu lts of clinical investigation(s) or other studies reported in s cientific literature, or reports published in peer reviewed sci entific 
literature on other clinical experience? If there are any diffe rences describe these and summarise the rationale provided by t he manufacturer. 
 
Has the manufacturer provided all Competent/Regulatory Authorit y correspondence (from all countries, including outside of EU) 
State Yes / No 
 
Are the conclusions drawn by the manufacturer, based upon the r esults of the clinical investiga tion, valid in the light of the  approved clinical investigation plan? 
Provide detail  
If clinical investigations not performed under Regulation (EU) 745/2017 were not publicly registered or published: 
 Confirm that a rationale was provided. 
 Confirm that the SSCP and where relevant the IFU (for example w ith respect to the description of clinical benefits) adequately  provide information for the intended user and if 
relevant, the patient. 
Clinical Investigation  Plan (CIP) reference 
 CIP complies with MDR, Annex XV, and EN ISO 14155 Annex A  
State Yes / No 
 CIP scope and study design  
Adequacy of CIP scope and study design for demonstration of saf ety, performance and benefit risk of subject devices: 
 Study design. 
 Devices identified.  
 Patient population. 
 Patient numbers. 
 Objectives and endpoints. 
 Length of follow up and intervals. 
 Study locations. 
 Overall conclusions. 
Non-compliances identified and resolved for this section may be  briefly described in this box Medical Devices 
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 Manufacturer clinical investigati ons and related documentation are: 
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
 
Section F: PMS, PMCF and the plan for updates 
Documents reviewed, where relevant: 
☐ PMS Plan  
☐ PMS Report (where relevant)  
☐ PMCF Plan  
☐ PMCF Report (where relevant)  
☐ PSUR (if available) 
Include references to the above documents. The demonstration of equivalence and the link to post-market cl inical follow-up 
Describe how the manufacturer will verify the presumption that there would be no clinically significant difference in the safe ty and clinical performance of the device under evaluation 
compared with the equivalent device by post market surveillance  or post market clinical follow-up? 
 Is there a post-market clinical follow-up planned? 
State Yes / No 
 Is this an implantable or class III device for which clinical i nvestigations have not been perfo rmed in accordance with Articl e 61(4)? 
State Yes / No 
For these devices the PMCF plan should include post market clin ical studies to demonstrate the safety and performance of the d evice. 
 Medical Devices 
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 Clinical evaluation updates: 
Identify when updates to the clinical evaluation report shall b e assessed during the surveillance and post certification monit oring activities and which frequency should be considered.  
Provide further detail taking into account the manufacturer's P MCF plan and the post-market surveillance plan.  
Non-compliances identified and resolved for this section may be  briefly described in this box 
The PMS, PMCF and the plan for updates are: 
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
 
 
Section G: IFU, SSCP, labelling and other information supplied with the device 
 
Information materials supplied by the manufacturer and the inst ructions for use: 
Describe what has been reviewed – IFU, promotional materials (i f available), SSCP, labelling etc.  In case several documents ha ve been assessed, identify answers to the questions below for 
each of the documents.22  
 
                                            
22 Note that the SSCP requires a separate validation report. Comments on appropriateness of PMS/PMCF Plan: 
 
If no PMCF is planned, has the manufacturer provided an accepta ble justification for not conducting a PMCF? 
State Yes / No  
 Medical Devices 
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 Intended purpose: 
Does the clinical evidence support this? 
Intended patient population: Who is the intended patient population?  Does the clinical evidence support this? 
Are all the appropriate/relevant restrictions, warnings or cont raindications in place?  
 
Intended users: 
Is the device to be used by healthcare professionals or lay use rs? Does the IFU provide all the appropriate/relevant informati on for the intended user?  
Has the manufacturer taken into account the technical knowledge , experience, education, training and use environment, where ap plicable, and the medical and physical conditions of 
intended users (design for lay, professional, disabled or other  users). 
Is any training for users required as a risk control measure? I f not, is this justified with respect to the risk management fi le and the clinical evaluation? 
 
Limitations: 
Has the manufacturer adequately/clearly described any limitatio ns for the device use? 
Does the device require any specific limitations? 
 
Contraindications: Have contraindications been adequately/clearly described? 
Are any further contraindications necessary?  
 
Warnings and precautions:  
Have warnings, precautions and/or measures to be taken in the e vent of malfunction of the device or changes in its performance  that may affect safety been adequately descried? 
 
Does the information supplied by the manufacturer adequately/cl early provide the safety and performance information relevant t o the user, or any other person, as appropriate/relevant? 
Is the estimation of associated risks and residual risk adequat e? Is this estimation quantitative (i.e. a percentage rate or r ate with a confidence interval) or qualitative? Is the descript ion 
appropriate for patients and users? Is the information provided to the end user written in a clear and understandable way (instruction s of use, indications, and w arnings)? 
 
Is the IFU and other information materials supplied by the manu facturer aligned with the other parts of the technical document ation? 
Consider: 
• the clinical evaluation (the dev ice description used for the cl inical evaluation, other content s of the clinical evaluation re port).  
• the available clinical data (such as the public registration an d results of clinical investigations, publications, PMCF studie s, etc.). Medical Devices 
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 • PMS report or PSUR. 
• the risk management file. 
 
Non-compliances identified and resolved for this section may be  briefly described in this box 
IFU, promotional materials, labelling are:  
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ 
 
Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
 
 
Section H: Summary of all available data and conclusions  
Has the manufacturer conducted clinical investigation(s) for th e device under evaluation? 
State Yes / No  
Has the manufacturer demonstrated equivalence with respect to s ection 3 of Annex XIV of the MDR?  
State Yes / No 
 
If the manufacturer conducted CIs, does clinical data from clin ical investigations of the device under evaluation adequately d emonstrate compliance with the relevant general safety and 
performance requirements? 
State Yes / No  
Has the reliability of the sourc e of clinical investigation dat a been assured through monitoring activities and verification o f the application of appropriate clinical research standards? 
State Yes / No  
If the manufacturer demonstrated equivalence with respect to se ction 3 of Annex XIV of the MDR does the data from an equivalen t device demonstrate compliance with Annex I? State Yes / 
No Medical Devices 
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 Provide a summary of safety data (with reference to the relevan t section of the CER). 
 
Provide a summary of performance data (with reference to the re levant section of the CER) 
 
Does the clinical data provide su fficient clinical evidence to:23 
• Demonstrate compliance with the relevant general safety and per formance requirements? State Yes  / No, and provide additional i nformation if relevant  
• Support the intended purpose, the claims and the information in  the IFU and SSCP?  State Yes / No, and provide addi tional information if relevant  
 
What are the remaining unanswered questions regarding the devic e under evaluation? 
Describe these with respect to the plan for PMS / PMCF  
 
 
 
Overall Conclusions:  
Benefit-risk conclusions: 
Summarise the clinical benefits. D escribe them briefly in relat ion to the meaningful and measu rable patient relevant clinical outcomes, including outcome(s) related to diagnosis. Describe 
their positive impact on patient management or public health.  
Summarise the risks with clinical relevance (e.g uncertainties or limitations of clinical data, undesirable side-effects, pote ntial for misuse, etc) and provide a short description (e.g. in cidence, 
severity, duration, vulnerable patient subgroups, dose-response  relationship where relevant, etc). 
Discuss the impact of risks (as described above) in relation to  the clinical benefits taking into account the factors describe d and in particular the uncertain ties in relation to available clinical 
data. 
 
Have all the risks that could have a significant impact on the benefit-risk analysis' been identified in the clinical evaluati on?  
Is there alignment between the risk management and clinical eva luation? 
 
                                            
23 For legacy products, see MDCG 2020-6  Medical Devices 
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 State Yes / No 
Describe how the clinical benefits outweigh the risks also cons idering the current state of the art.  
 
Have all deficiencies/non-compliances been raised and satisfact orily addressed in the course of this clinical evaluation asses sment?  
 
State Yes / No 
 
Is it possible to follow the changes that have been made to add ress them?  
Overall conclusion on the assessment of the manufacturer's clin ical evaluation including a clinical judgement of the opinion p rovided by any external expert. 
Make a clear recommendation to the  notified body's decision mak er in regards to the conclusions of this assessment for the pur pose of granting certification, stating in addition: 
• whether the post-market surve illance plan, including the PMCF p lan, is adequate.  
• specific milestones to be set for further review of the up to d ate clinical evaluation by the notified body.  
• considerations to define the period of certification. 
• additional conditions on the cer tification to be considered.  
 
Sufficient information are prov ided to demonstrate acceptabilit y of benefit-risk conclusions and confirm that the relevant MDR  requirements are met : ☐ 
 
Specific Considerations 
 
Section I: Clinical evaluation consultation procedure for certa in class III and class IIb  devices (Article 54) 
 
Is the procedure required by Article 54(1) to be applied? State Yes / No Provide further information where necessary with respect to thi s justification 
 
If this procedure is not to be applied, with respect to Article  54(2) what is the reason?
24 
                                            
24 See MDCG 2019-3, Interpretation of Article 54(2)b  Medical Devices 
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 (a) renewal of a certificate issued under the MDR; ☐ 
(b) the device has been designed by modifying a device already marketed by the same manufacturer for the same intended purpose , and the manufacturer has demonstrated to the 
satisfaction of the notified body that the modifications do not  adversely affect the benefit-risk ratio of the device; ☐ 
 Provide a summary of the modification(s) that have been made to  the device? 
Provide a summary of the manufacturer’s rationale demonstrating  that the benefit-risk ratio of the device is not adversely aff ected. 
Has the clinical data been provided to support the conclusions of the manufacturer regarding the benefit-risk of the modified device with respect to the previous version? 
 For legacy devices, verify:  
 that the modifications do not adversely affect the benefit-risk  ratio. 
 that the device in question had a valid certificate under the D irectives. 
 in case the certificate has been withdrawn, suspended
25 or expired, if there is an impact on compliance with the gener al safety and performance requirements, and 
 that there is no pending assessment of changes for the device o r outstanding non-compliance. 
 the description of modifications provided and assess if these m odifications are limited only to those needed in order to compl y with the new legal requirements introduced by the MDR. 
 
Note: limitations of the intended purpose of the device should not trigger the consultation procedure in accordance to Art. 54 . 
 
(c) the principles of the clinical  evaluation of the device typ e or category have been addressed in a CS referred to in Articl e 9 and the notified body confir ms that the clinical evaluation  of 
the manufacturer for this device is in compliance with the rele vant CS for clinical evaluation of that kind of device. ☐ 
Relevant scientific panel and associated competence area(s)  
Indicate your opinion on the r elevant scientific and associated  competence area(s)  for the device under assessment: 
 
  Medical area(s)  Associated competence-related areas  
 Orthopaedics, traumatology, rehabilitation, 
rheumatology   Joint replacements (hip, knee, shoulder) 
 Spinal devices 
 Non-articulating devices, rehabilitation 
 Other 
                                            
25 The devices for which the certificates were withdrawn or suspe nded due to lack of compliance wi th essential requirements will  require a clinical evaluation consultation procedure as this 
adversely affects the benefit-risk ratio of the device.  Medical Devices 
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  Circulatory system: cardiovascular / lymphatic 
system   Prosthetic heart valves and devices for heart valve repair 
 Cardiovascular stents (metallic and bioresorbable) and vascular  prostheses 
 Active implantable cardiac devic es and electrophysiological dev ices 
 Structural interventions and new devices (e.g. LAA/PFO occluder s, heart failure devices) 
 Cardiac surgery including extracorporeal membrane oxygenation, cardiopulmonary bypass devices, artificial hearts (and 
left ventricular assist devices) 
 Other 
 Respiratory, anaesthesiology, intensive care   Respiratory and anaesthetic devices 
 Neurology   Central and peripheral nervous system devices 
 Implants for hearing and vision (sensory recovery) 
 Neurosurgical devices 
 Other 
 Endocrinology and diabetes   Endocrinology and diabetes (e.g. insulin delivery systems and c losed-loop systems, continuous glucose monitoring)  
Implantable systems 
 General and plastic surgery, dentistry   Surgical implants and general surgery 
 Plastic surgery and wound care 
 Maxillofacial surgery 
 Dentistry (devices for dentistry  (oral surgery, implantology, d ental materials incl.)) 
 Other 
 Obstetrics & gynaecology including reproductive 
medicine   Devices for obstetrics and gynaecology 
 Gastroenterology & hepatology   Devices for gastroente rology and hepatology 
 
 Nephrology & urology  Devices for nephrology and urology 
 Ophthalmology  Devices for ophthalmology Medical Devices 
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Provide further information necessary with respect to this just ification 
 
 
Conclusion for certain class III and IIb devices to be consider ed by the expert panel 
Novel aspects 
See section C, subsection ‘Novelty’ 
  
 
Benefit-risk determination  See section H and the Overall Conclusion sections 
 
Consistency of clinical evidence with intended purpose and PMCF  
Provide an assessment of the consistency of the clinical eviden ce with:  
(a) the intended purpose, including medical indication(s),  
(b) the post-market clinical follow-up (PMCF) plan. 
 
 
 
Section J: Where demonstration o f conformity based on clinical data is not deemed appropriate (Article 61(10)) 
 
Has the manufacturer claimed that the demonstration of conformi ty with general safety and performance requirements based on cl inical data is not deemed appropriate in accordance 
with Article 61(10)? 
State Yes / No 
Nota bene : A clinical evaluation is still required and the above informa tion and evidence-based justifica tion shall be presented in the  clinical evaluation report. 
 Has the manufacturer provided a justification for reliance upon  Article 61(10)? 
State Yes / No 
 If yes, describe the evidence which the manufacturer is relying on, w ith respect to: 
 Performance evaluation 
 Bench testing  Medical Devices 
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  Pre-clinical evaluation 
 
Consider: 
 Has any available clinical data for the device or an equivalent  device been searched for and/or identified by the manufacturer ?  
If yes –was the identified clinic al data integrated in the clin ical evaluation. 
This should include an evaluation of clinical data identified f rom the literature, and an appraisal of their relevance to the device under evaluation. 
 
 Is clinical data available for si milar devices, does this provi de information with relevant to the safety and performance of t he device under evaluation? 
Has the manufacturer conducted an appropriate search of scienti fic literature?  
If clinical data for similar devi ces is available – this should  be included in the CER and evaluated and may be of particular relevance to post-market surveillance / PMCF planning. 
 
 The results of the manufacturer's risk management 
Are the results of the manufacturer's risk management supportiv e of the use of non-clinical testing methods? 
 
 Consideration of the specifics of the interaction between the d evice and the human body 
Is the device under assessment part of a system or stand-alone?  
Is there sufficient information regarding this interaction avai lable from sources other than clinical data?  
 
 The clinical performance intended 
What is the intended performance? Is it reasonable to rely upon  non-clinical data for the proposed intended performance? 
 
 The claims of the manufacturer  
The manufacturer should not make any claims which are not suppo rted by clinical data. 
 
 Overall conclusion  
 
Non-compliances identified and resolved for this section may be  briefly described in this box 
The justification of the manufacturer for reliance upon Article  61(10) is:  
Compliant with the applicable requirements of the MDR: ☐ 
Include any relevant comments 
Compliant with the applicable requirements of the MDR with the exception of the minor non-compliance below: ☐ Medical Devices 
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Add a clear description of any remaining minor non-compliance t ogether with required follow-up actions to close them and timel ines for their completion to be followed by the 
manufacturer. 
 
 
Section K: The voluntary clinical consultation on the clinical development strategy (Article 61(2))  
Expert Panel consultation reference: 
 Expert Panel recommendations: 
Have the views of the expert panel been given due consideration  by the manufacturer? 
Has this been included in the  clinical evaluation report? 
Is there any divergence between the manufacturers clinical deve lopment strategy and the views of the expert panel? If yes – wh at is the justification for this? Is this acceptable? Explain 
why.