Everything a medical device manufacturer needs to understand about the Clinical Evaluation Report — structure, regulatory basis, MDCG 2020-13 requirements, and the most common reasons Notified Bodies reject or raise questions on CER submissions. Written by former TUV SUD reviewers.
The CER is the central clinical evidence document in a medical device technical file. Under EU MDR 2017/745, it is a legal requirement for all CE-marked devices — and 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 post-market clinical follow-up (PMCF), post-market surveillance (PMS), and regulatory guidance evolution. For Class IIb and III devices, annual updates are the baseline expectation of most Notified Bodies.
The regulatory basis for the CER is Article 61 of EU MDR 2017/745, together with Annex XIV Part A (clinical evaluation methodology) and the guidance document MDCG 2020-13, which provides the current authoritative framework for CER structure and content. The earlier MEDDEV 2.7/1 Rev.4 remains relevant as background reference but is not the primary framework for EU MDR submissions.
Critically, the CER must be grounded in a Clinical Evaluation Plan (CEP) — a pre-specified methodology document that defines how the clinical evaluation will be conducted, what data sources will be used, and how equivalence (if claimed) will be demonstrated. Producing a CER without a validated CEP is a common and consequential error under EU MDR.
Defines scope, methodology, equivalence strategy, and data sources before evaluation begins. Mandatory under EU MDR.
PRISMA-compliant search across multiple databases. Documented inclusion/exclusion criteria. No cherry-picking of favourable data.
Technical, biological, and clinical equivalence demonstrated across all three dimensions. For Class III: access agreement required.
Each data source assessed for methodological quality, applicability, and contribution to the clinical evidence base. Not just citation summaries.
Transparent conclusion on clinical benefit, residual risk acceptability, and state-of-the-art alignment. Directly linked to PMCF plan data gaps.
CER conclusions must explicitly identify unresolved data gaps and confirm how the PMCF plan will address them. The two documents are interdependent.
Based on the direct review experience of Eclevar's team — including former assessors at TUV SUD — these are the most frequent reasons a CER fails to satisfy a Notified Body, triggering requests for information (RFIs), major non-conformities, or outright rejection of the technical file.
Former TUV SUD Reviewer
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. This is by far the most common procedural finding in first-time EU MDR CER submissions.
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 — regardless of how similar the devices are clinically. Many manufacturers are unaware that this requirement effectively closes the equivalence pathway for the vast majority of Class III devices, making clinical investigation data the default requirement.
A CER literature section that lists papers with one-paragraph summaries is not a systematic review. Notified Bodies require: a documented search strategy with database names, date ranges, and search strings; a PRISMA flow diagram showing papers identified, screened, and excluded with reasons; and critical appraisal of each included paper for methodological quality using a validated tool (Oxford Levels of Evidence, GRADE, or similar). Without these elements, the literature review is considered non-systematic and the CER conclusions lack a defensible evidentiary foundation.
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, competing devices, and current clinical practice guidelines. Residual risks must be assessed relative to what a clinician could reasonably expect from the best available alternative — not in isolation.
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. The PMCF Plan must contain a gap-by-gap response to CER findings, with specific PMCF activities (surveys, registries, literature monitoring, clinical investigations) assigned to each unresolved evidence gap.
A CER that was written at the time of initial CE marking and has not been updated since — despite PMCF surveys, literature monitoring, or new clinical investigation data being available — fails the EU MDR requirement for continuous clinical evaluation. Notified Bodies review the CER revision history at surveillance audits and will raise a finding if the document has not been updated to reflect new post-market evidence, particularly for Class IIb and III devices.
EU MDR Annex XIV Part A requires that the clinical evaluation is performed by individuals with sufficient clinical, scientific, and regulatory expertise relevant to the device type and intended indication. Many manufacturers do not document the evaluator's qualifications within the CER itself — or assign the work to regulatory affairs personnel who lack the clinical background required. Notified Bodies increasingly request CVs and qualification statements for all named clinical evaluators during technical file review.
A structured comparison of the three frameworks governing clinical evaluation for CE-marked medical devices. Understanding the differences is essential for manufacturers transitioning from MDD/AIMD legacy files to EU MDR compliance.
| Requirement / Topic | 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 in legacy files. | Mandatory. Must be produced before evaluation begins. | Detailed CEP content requirements specified. Must include scope, methodology, equivalence strategy. |
| Equivalence — Class III | Equivalence pathway broadly available. Access agreement not required. | Restricted. Contractual access to equivalent device's technical documentation required. | Clarifies that the access requirement applies strictly. Provides criteria for all three equivalence dimensions (technical, biological, clinical). |
| Literature search methodology | Systematic review recommended. Methodology documentation variable in practice. | Reproducible, systematic approach required. No specific methodology mandated. | PRISMA-compliant approach described. Database list, search strings, and inclusion/exclusion criteria must be documented and reproducible. |
| Critical appraisal | Required but approach left to manufacturer discretion. Often limited in practice. | Appraisal of clinical data required as part of evaluation. | Validated appraisal tools recommended. Each data source must be assessed for quality, relevance, and weighting. Oxford Levels of Evidence referenced. |
| Benefit-risk evaluation | Required. Comparison with alternative treatments expected. | Explicitly required. Must include state-of-the-art for the indication. | Detailed framework. Benefit-risk must be assessed against GSPR (Annex I) requirements and current clinical practice. |
| PMCF plan linkage | PMCF addressed separately. Explicit CER-PMCF gap mapping not required. | CER conclusions must feed directly into PMCF Plan. Data gaps must be addressed by PMCF activities. | CER and PMCF Plan described as companion documents. Gap mapping requirement explicitly stated. |
| Update frequency | Periodic update recommended. No minimum frequency specified. | Continuous update required. Annual minimum for Class IIb and III. | Recommends documented review decision even when no update is required. Update trigger criteria specified. |
| Evaluator qualification | Qualified person requirement stated. Qualification documentation variable. | Sufficient expertise in clinical, scientific, and regulatory fields required. Documented in CER. | CV and qualification statement to be included in CER. Specific expertise in indication area required. |
| SSCP requirement | No equivalent requirement under MDD. | Mandatory for Class III and implantable devices. Public document on EUDAMED. | SSCP addressed in separate guidance document (MDCG 2019-9 Rev.1). |
Table compiled by Eclevar MedTech based on MEDDEV 2.7/1 Rev.4 (2016), EU MDR 2017/745 Annex XIV, and MDCG 2020-13 (2020). For regulatory decisions, always refer to the primary regulatory documents. Last reviewed April 2026.
Answers based on EU MDR 2017/745, MDCG 2020-13, and the operational experience of Eclevar's former Notified Body reviewers.
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, device design changes, or changes to the intended purpose. The CER review decision must be documented even when no update is required — the absence of a review record is itself a finding.
The CER is a confidential internal technical document — detailed, methodology-heavy, and not publicly available. The SSCP (Summary of Safety and Clinical Performance) is a public-facing summary required for Class III and implantable devices under Article 32. The SSCP is derived from the CER, validated by the Notified Body, and published on EUDAMED. It must be written for both healthcare professional and lay audience comprehension.
Not necessarily, but for Class III devices the pathways to avoid clinical investigations are narrow under EU MDR. Equivalence to another manufacturer's device requires a formal access agreement to their technical file — rarely obtainable in practice. Where equivalence cannot be demonstrated and existing clinical data is insufficient, clinical investigations become the default requirement. Early feasibility assessment of equivalence viability is essential before committing to a CER strategy.
Based on Eclevar's former TUV SUD reviewers: (1) a validated CEP dated before the evaluation; (2) a PRISMA-compliant literature search with documented methodology; (3) genuine critical appraisal of every data source; (4) a defensible equivalence claim with access agreement if applicable; (5) a benefit-risk conclusion benchmarked against state-of-the-art; (6) explicit PMCF plan alignment addressing every data gap identified in the CER.
MDCG 2020-13 is the current authoritative guidance for clinical evaluation under EU MDR, published by the Medical Device Coordination Group. It supersedes MEDDEV 2.7/1 Rev.4 as the primary framework for EU MDR CER submissions. Key differences include: mandatory CEP before evaluation begins; stricter equivalence requirements for Class III; explicit PRISMA-compliant literature review standards; and mandatory CER-PMCF gap mapping. Any CER structured solely around MEDDEV 2.7/1 Rev.4 without MDCG 2020-13 alignment is likely to receive comments from a Notified Body during technical file review. See our comparison table above for a full side-by-side breakdown.
Eclevar resources and service pages with strong authority on the topics that surround the CER.
