Client Login Book Free Call
Clinical Evaluation Report (CER) Under EU MDR 2017/745: Complete Guide 2026 | Eclevar MedTech
Complete Guide — Updated April 2026

Clinical Evaluation Report (CER) Under EU MDR 2017/745

Everything a manufacturer needs to understand about the CER — structure, regulatory basis, MDCG 2020-13 requirements, and the most common reasons Notified Bodies reject submissions.

Framework EU MDR 2017/745
Guidance MDCG 2020-13
Standard ISO 14155:2020
In this guide Explore Rejections
Section 01

What is a Clinical Evaluation Report?

The CER is the central clinical evidence document in a medical device technical file. Under EU MDR 2017/745, its quality is one of the most scrutinised elements in a Notified Body review.

A Clinical Evaluation Report (CER) is a systematically structured document that evaluates the clinical evidence available for a medical device. Its purpose is to demonstrate that the device achieves its intended clinical benefit, that the risks are acceptable in relation to those benefits, and that the clinical evidence is sufficient to support CE marking under EU MDR 2017/745.

The CER is not a one-time document. Under EU MDR, it is a living document that must be continuously updated as new clinical data becomes available — through PMCF, PMS, and regulatory guidance evolution.

Critically, the CER must be grounded in a Clinical Evaluation Plan (CEP). Producing a CER without a validated CEP is a common and consequential error under EU MDR.

01
Annex XIV Part A

Clinical Evaluation Plan (CEP)

Defines scope, methodology, equivalence strategy, and data sources before evaluation begins.

02
MDCG 2020-13

Systematic Literature Review

PRISMA-compliant search across multiple databases. Documented inclusion/exclusion criteria.

03
MDCG 2020-5

Equivalence Assessment

Technical, biological, and clinical equivalence demonstrated. For Class III: access agreement required.

04
Annex XIV Part B

PMCF Plan Alignment

CER conclusions must explicitly identify unresolved data gaps addressed by the PMCF plan.

Section 02 — Notified Body Perspective

Common CER rejections by Notified Bodies

Based on the direct review experience of Eclevar's team — including former assessors at TÜV SÜD — these are the most frequent reasons a CER fails to satisfy a Notified Body.

Dr. Nikhil Khadabadi
Dr. Nikhil Khadabadi
Ex TÜV SÜD Reviewer
"The majority of CER deficiencies I reviewed at TÜV SÜD were not failures of clinical evidence — they were failures of methodology documentation. Manufacturers had the data. They simply had not demonstrated how they evaluated it."
R1

No Clinical Evaluation Plan — or a CEP produced after the CER

The CEP must be written and validated before the clinical evaluation begins. A CEP that mirrors the CER — clearly written after the fact — is treated by most Notified Bodies as a major non-conformity. The CEP is the methodology declaration: if it does not pre-date the evaluation, it has no methodological value.

Produce the CEP first, have it reviewed internally or by an external EU MDR expert, then begin the systematic literature search. The CEP must be version-controlled and dated prior to any data retrieval.
R2

Equivalence claimed for Class III devices without an access agreement

Under EU MDR, demonstrating equivalence to a device manufactured by another company requires a formal contractual agreement giving access to the equivalent device's technical documentation. Without this agreement, the equivalence claim cannot be substantiated.

Conduct a realistic equivalence feasibility assessment early. If a valid access agreement cannot be obtained, plan clinical investigations accordingly — do not build a CER strategy on an equivalence claim that cannot be defended.
R3

Literature review that is a citation list, not a systematic evaluation

A CER literature section that lists papers with one-paragraph summaries is not a systematic review. Notified Bodies require: a documented search strategy, a PRISMA flow diagram, and critical appraisal of each included paper for methodological quality using a validated tool (Oxford Levels of Evidence, GRADE).

Use a validated appraisal methodology. Document every step of the search and screening process. A proper systematic literature review for a Class IIb device typically takes 60 to 120 hours of qualified medical writer time.
R4

Benefit-risk conclusion not linked to state-of-the-art

A CER conclusion that simply states "the benefits outweigh the risks" without benchmarking against the state of the art for the intended indication is insufficient under MDCG 2020-13. The benefit-risk evaluation must explicitly compare the device's clinical profile against alternative treatments.

Include a dedicated state-of-the-art section in the CER that documents the current standard of care, available alternatives, and how the device's benefit-risk profile compares.
R5

PMCF plan does not address the data gaps identified in the CER

The CER and the PMCF Plan are companion documents. A CER that identifies data gaps — which it must, as no evidence base is ever complete — and a PMCF Plan that does not directly address those specific gaps is a structural inconsistency that Notified Bodies flag consistently.

Draft the CER and PMCF Plan in parallel. Create a formal data gap table in the CER, then map each gap to a specific PMCF activity in the PMCF Plan. The two documents must cross-reference each other explicitly.
Section 03 — Reference table

MEDDEV 2.7/1 Rev.4 vs EU MDR Annex XIV vs MDCG 2020-13

A structured comparison of the three frameworks governing clinical evaluation for CE-marked medical devices.

Requirement MEDDEV 2.7/1 Rev.4 (MDD era) EU MDR Annex XIV Part A MDCG 2020-13 (Current guidance)
Legal status Non-binding guidance. Reference for legacy MDD files. Legally binding. Directly applicable to all EU MDR CERs. Authoritative guidance on Annex XIV implementation. De facto requirement.
Clinical Evaluation Plan (CEP) Recommended but not explicitly required. Often absent. Mandatory. Must be produced before evaluation begins. Detailed CEP content requirements specified. Must include scope & equivalence strategy.
Equivalence — Class III Equivalence pathway broadly available. Restricted. Contractual access to equivalent device's technical documentation required. Clarifies that the access requirement applies strictly. Provides criteria for all 3 dimensions.
Literature search Systematic review recommended. Documentation variable. Reproducible, systematic approach required. PRISMA-compliant approach described. Search strings and criteria must be documented.
Critical appraisal Required but approach left to manufacturer discretion. Appraisal of clinical data required. Validated tools recommended (Oxford Levels, GRADE). Each source assessed for quality.
PMCF plan linkage PMCF addressed separately. Gap mapping not required. CER conclusions must feed directly into PMCF Plan. CER and PMCF Plan described as companion documents. Gap mapping requirement explicitly stated.
Section 04 — FAQ

Frequently asked questions

When does a CER need to be updated?

Under EU MDR, the CER must be updated continuously and at minimum annually for Class IIb and III devices. Updates are triggered by new PMCF data, PMS safety signals, MDCG guidance updates, or changes to the intended purpose.

What is the difference between a CER and an SSCP?

The CER is a confidential internal technical document. The SSCP (Summary of Safety and Clinical Performance) is a public-facing summary required for Class III and implantable devices under Article 32, published on EUDAMED.

Does a CER require clinical investigations?

Not necessarily, but for Class III devices the pathways to avoid clinical investigations are narrow. Equivalence requires a formal access agreement to another manufacturer's technical file — rarely obtainable. Where equivalence cannot be demonstrated and existing data is insufficient, clinical investigations become the default requirement.

Reforming Clinical Evaluation of Medical Devices in Europe