---
title: The Clinical Evaluation Report (CER) Under MDR: Structure and Common Mistakes
description: The CER is the central clinical document in the technical file. Here is the structure, the mandatory content, and the mistakes that trigger nonconformities.
authors: Tibor Zechmeister, Felix Lenhard
category: Clinical Evaluation & Investigations
primary_keyword: clinical evaluation report CER MDR
canonical_url: https://zechmeister-solutions.com/en/blog/clinical-evaluation-report-cer-mdr
source: zechmeister-solutions.com
license: All rights reserved. Content may be cited with attribution and a link to the canonical URL.
---

# The Clinical Evaluation Report (CER) Under MDR: Structure and Common Mistakes

*By Tibor Zechmeister (EU MDR Expert, Notified Body Lead Auditor) and Felix Lenhard.*

> **The clinical evaluation report (CER) is the document that presents the output of the clinical evaluation process at the point of conformity assessment. Under MDR Article 61 and Annex XIV Part A, the CER must document the scope of the evaluation, the data identified from literature, equivalence, and clinical investigations, the appraisal of that data against pre-specified criteria, the analysis against the relevant general safety and performance requirements, and a conclusion on safety, performance, clinical benefits, and benefit-risk. It is the central clinical document in the technical file, and it is where Notified Bodies focus their most detailed clinical review.**

**By Tibor Zechmeister and Felix Lenhard. Last updated 10 April 2026.**

---

## TL;DR

- The CER is defined by MDR Article 61(12) and Annex XIV Part A paragraph 4. It is the document-form output of the clinical evaluation process, not the process itself.
- Annex XIV Part A prescribes a defined, methodologically sound procedure: clinical evaluation plan, systematic scientific literature review, evaluation of clinical investigations, and consideration of currently available alternative treatment options.
- MDCG 2020-5 (April 2020) is the authoritative MDR-era interpretation for the equivalence route. MEDDEV 2.7/1 Rev 4 (June 2016) is the legacy structural guide that many NBs still use as a format reference; the MDR text takes precedence wherever they diverge.
- The four-stage data treatment. Scoping, identification, appraisal, analysis. Is the backbone of every well-built CER.
- Common CER mistakes cluster around five patterns: unclear intended purpose, reverse-engineered appraisal criteria, weak equivalence claims, missing GSPR mapping, and a disconnected risk file and PMS plan.
- The CER is reviewed by the Notified Body as the clinical core of the technical documentation. A weak CER will not pass clinical review, no matter how polished the rest of the file is.

---

## What a clinical evaluation report actually is

The clinical evaluation report is the document that presents the clinical evaluation. The clinical evaluation itself is the process defined in MDR Article 2(44) and governed by Article 61 and Annex XIV Part A. The CER is what the process produces on paper at the point when conformity with the general safety and performance requirements has to be demonstrated.

Two distinctions matter before anything else. First, the CER is not the clinical evaluation plan (CEP). The CEP is the pre-specified plan written before data is collected; the CER is the report that documents what was done against that plan. Writing a CER without a CEP is writing conclusions without a method, and Notified Bodies catch this pattern every time. Second, the CER is not a literature review. A literature review is one possible data source inside the CER; the CER encompasses literature, equivalence data, clinical investigation data, and the analysis that ties all of it to the GSPRs.

MDR Article 61(12) requires the results of the clinical evaluation and the clinical evidence on which it is based to be documented in a CER which shall support the assessment of conformity of the device. Annex XIV Part A paragraph 4 adds that the CER and the underlying clinical evidence shall allow the manufacturer to demonstrate conformity and be part of the technical documentation referred to in Annex II. The CER lives in the technical file, it is reviewed during conformity assessment, and it is updated across the lifecycle of the device under Article 61(3) and Annex XIV Part B.

The CER also has a direct cross-reference obligation. It has to be consistent with the risk management file under EN ISO 14971:2019+A11:2021, with the post-market surveillance plan under Annex III, and with the PMCF plan under Annex XIV Part B. A CER that disagrees with the risk file or the PMS plan is not a complete CER. It is three documents pretending to belong to the same device.

## The structure of a CER: section by section

Annex XIV Part A does not specify a rigid chapter list, but it does specify the content the CER must cover. MEDDEV 2.7/1 Rev 4 (June 2016) provides a structural template that many manufacturers and Notified Bodies still use as a format reference, updated where MDR text supersedes it. The sections below are the ones that consistently appear in CERs that survive Notified Body review.

**1. Administrative information and device identification.** Manufacturer, authorised representative, UDI-DI where applicable, device model, variants, accessories, versions, risk class and applicable classification rule from Annex VIII, conformity assessment route, and the version and date of the CER itself. This section is boring and essential. A CER without a clear version history cannot be updated; a CER without clean device identification cannot be mapped to the rest of the technical file.

**2. Scope of the clinical evaluation.** The intended purpose exactly as it appears on the label and IFU, the intended target population and indications, the contraindications, the intended users, the intended use environment, the clinical claims and clinical benefits to be substantiated, and an explicit link to the CEP in which these were pre-specified. Scope drift between the CEP and the CER is the most common reason a CER collapses under review.

**3. Device description and state of the art.** A concise description of the device, its operating principle, its components, and how it fits within currently available alternative treatment options. Article 61(2) explicitly requires consideration of those alternatives. The state-of-the-art section defines the clinical benchmark against which the device is going to be compared.

**4. Pre-specified clinical evaluation plan reference.** The CER must explicitly reference the CEP and confirm that the evaluation was conducted according to the plan. Deviations from the plan are documented here with justification. Appraisal criteria, inclusion and exclusion criteria, and analysis methods must be the ones specified in the CEP, not ones invented after the data was read.

**5. Data identified. Literature.** The systematic literature review: databases searched, search strings, dates, PRISMA-style flow, full set of retrieved records, reasons for exclusion, final set of included records. The search must be reproducible from the description alone.

**6. Data identified. Equivalence.** If equivalence is claimed, the full equivalence analysis under MDCG 2020-5 (April 2020): technical, biological, and clinical characteristics compared side by side, the demonstration of no clinically significant differences, the evidence for sufficient levels of access to the clinical data of the equivalent device, and a clear statement of which clinical data of the equivalent device is being relied on.

**7. Data identified. Clinical investigations.** All clinical investigations on the device, whether conducted by the manufacturer or identified in the literature. Each investigation is summarised with design, population, endpoints, results, strengths, limitations, and applicability to the device under evaluation. Clinical investigations conducted under EN ISO 14155:2020+A11:2024 are referenced with their investigation plan version and final report.

**8. Appraisal of the data.** Every data set is appraised against the pre-specified criteria. Quality of methods, quality of results, relevance to the device, relevance to the intended purpose, and overall weight assigned to the data set. This is where the CEP-specified appraisal grid is actually applied. A CER in which every source is described but no source is appraised is incomplete.

**9. Analysis against the GSPRs.** The central intellectual step of the CER. The appraised data is analysed against the specific Annex I general safety and performance requirements that require clinical evidence to be demonstrated. Each relevant GSPR is traced to the data that supports it. Gaps are identified. Residual risks are linked back to the risk management file. Article 61(2) requires a methodologically sound procedure. This section is where that methodology shows.

**10. Benefit-risk determination and conclusions.** The overall conclusion on safety, performance, clinical benefits, and the acceptability of the benefit-risk ratio under normal conditions of use, explicitly traceable to the data and the analysis. Any residual uncertainty is stated, not hidden, and addressed by the PMCF plan.

**11. PMCF plan reference and lifecycle statement.** The CER points to the PMCF plan under Annex XIV Part B and explains how PMCF data will close remaining uncertainties and feed into the next CER update. For Class III and implantable devices, the CER confirms the at-least-annual update cadence required by Article 61(3) and (6).

**12. Qualifications of the evaluators.** The authors of the CER, their credentials, their independence, and a CV or equivalent qualification statement. Annex XIV Part A requires the evaluation to be conducted by a suitably qualified individual or team, and the CER must demonstrate this.

## The four-stage data treatment

Underneath the section list is the four-stage data treatment that has been the structural backbone of clinical evaluation since MEDDEV 2.7/1 Rev 4 and remains structurally valid under the MDR, aligned with Annex XIV Part A.

**Stage 1. Scope (define what is being evaluated).** The intended purpose, the clinical benefits to be substantiated, the relevant GSPRs, and the questions the evaluation must answer. This stage belongs in the CEP but is restated in the CER for traceability.

**Stage 2. Identification of clinical data.** Literature search, equivalence analysis, and clinical investigation data collection, each conducted under pre-specified methods and with a full audit trail of what was searched, found, included, and excluded.

**Stage 3. Appraisal of each data set.** Structured, pre-specified appraisal of methodological quality and relevance. Every included data set receives a documented appraisal. Not a narrative sentence, a documented decision against the CEP-specified criteria.

**Stage 4. Analysis of the overall body of evidence against the GSPRs.** The appraised data is synthesised against each relevant GSPR, the benefit-risk is determined, gaps are identified, and PMCF activities are defined to close them. This is the stage where the CER either holds together or falls apart.

The four stages are not optional and they run in order. A CER that jumps from identification to conclusions without the appraisal and analysis stages is not a CER under MDR Article 61 and Annex XIV Part A; it is a literature dump with a conclusion taped to the back.

## How the CER links to the risk file and PMS

The CER is not an island. Three documents sit next to it in the technical file, and the CER must be consistent with all three.

**The risk management file under EN ISO 14971:2019+A11:2021.** Hazards, hazardous situations, risks, risk control measures, and residual risks. The CER must confirm that residual risks identified in the risk file are acceptable in light of the clinical benefits, and must feed clinical data back into the risk file where the data changes the estimated probability or severity of harm. If the risk file says one thing and the CER says another about the same clinical situation, the whole file is incoherent.

**The PMS plan under Annex III.** The PMS plan describes how post-market data will be collected and assessed across the lifecycle. The CER feeds the PMS plan by naming the uncertainties that PMS data must address, and the PMS plan feeds the CER by producing the data that updates it. For Class IIa, IIb, and III devices, the periodic safety update report (PSUR) under Article 86 summarises PMS findings and explicitly references the CER.

**The PMCF plan under Annex XIV Part B.** PMCF is the clinical subset of PMS. The PMCF plan defines the specific post-market clinical activities. Registries, ongoing literature surveillance, user surveys, focused post-market studies. That will close the clinical uncertainties identified in the CER. A CER that concludes "benefit-risk is acceptable" without naming the uncertainties the PMCF plan will address is a CER that has not been honest about its own limits.

The cross-reference obligation runs both ways. The CER references the risk file and the PMS and PMCF plans; the risk file and the plans reference the CER. Notified Bodies check this consistency. A CER that reads well in isolation but contradicts the risk file is a clinical nonconformity waiting to be written up.

## Common CER mistakes that trigger nonconformities

Five patterns show up repeatedly in CERs that fail clinical review. Each one is specific, concrete, and avoidable if the authors have read Annex XIV Part A carefully.

**Mistake 1. Unclear or drifting intended purpose.** The CEP says one thing, the CER says another, and the label and IFU say a third. Notified Bodies map these three against each other in the first pass of the review. Any drift between them is a finding. The fix is to freeze the intended purpose in the CEP, copy the exact wording into the CER, and verify that the label and IFU use the same sentence.

**Mistake 2. Reverse-engineered appraisal criteria.** The appraisal criteria appear in the CER for the first time, written in a way that happens to fit the data that was found. Under MDR Article 61(2) and Annex XIV Part A, the appraisal criteria must be pre-specified in the CEP, not back-filled. A CER whose appraisal criteria cannot be shown to predate the data collection will not survive methodological scrutiny.

**Mistake 3. Weak equivalence claims under MDCG 2020-5.** Equivalence is demonstrated on a single dimension (usually technical), the other two dimensions are hand-waved, the "sufficient levels of access" requirement is ignored, and the CER relies heavily on clinical data from a device the manufacturer has no ongoing data relationship with. Under MDCG 2020-5 (April 2020), equivalence requires simultaneous demonstration across all three dimensions. Technical, biological, and clinical. And the access-to-data requirement is explicit. The fix is either to build the full equivalence argument or to drop the equivalence claim and rely on literature and clinical investigations.

**Mistake 4. No explicit GSPR mapping.** The CER presents a large body of data and concludes that the device is safe and performs as intended, but never maps the data to the specific GSPRs in Annex I that require clinical evidence. The NB reviewer cannot see which data supports which requirement. The fix is a GSPR traceability table that lists the relevant clinical GSPRs in one column and the supporting appraised data in the next.

**Mistake 5. Disconnected risk file, PMS plan, and PMCF plan.** The CER does not reference the risk file, the residual risks in the risk file do not map to the clinical conclusions, and the PMCF plan does not name the uncertainties the CER raised. Each document reads plausibly in isolation. The package is incoherent. The fix is to build all four documents in the same review cycle and cross-check them explicitly.

## How Notified Bodies review the CER

Notified Body clinical review of a CER runs in a predictable sequence and it is worth understanding from the reviewer's side.

The reviewer starts with the intended purpose, the risk class, and the classification rule, and confirms these against the rest of the technical documentation. Any inconsistency is flagged immediately.

The reviewer then reads the CEP and checks that the CER references it and follows it. Pre-specified methods, pre-specified appraisal criteria, and pre-specified acceptance thresholds are checked for consistency between the two documents.

The reviewer then walks through the four-stage data treatment. Was the literature search reproducible? Were the inclusion and exclusion criteria applied as stated? Was equivalence demonstrated under MDCG 2020-5 on all three dimensions? Were clinical investigations conducted under EN ISO 14155:2020+A11:2024 where applicable? Was each data set appraised against the pre-specified grid?

The reviewer then reads the GSPR analysis. Every relevant Annex I clinical GSPR must be traceable to appraised data. Gaps are flagged. The benefit-risk determination is checked for consistency with the appraised data and with the risk management file.

The reviewer then reads the PMCF plan and checks that it addresses the uncertainties raised in the CER. For Class III and implantable devices, the annual update cadence under Article 61(3) is verified.

The reviewer concludes with a consistency check against the rest of the technical documentation. Label, IFU, risk file, PMS plan, PSUR where applicable. A CER that is internally excellent but externally inconsistent will still produce nonconformities.

This is not a mysterious process. Every step maps to a specific MDR article, annex, or MDCG guidance. A CER built with the reviewer's sequence in mind is much cheaper to write than a CER that has to be rebuilt after the first round of findings.

## The Subtract to Ship angle

The Subtract to Ship Framework applied to the CER produces one discipline: every section and every claim must trace to a specific MDR article, annex paragraph, or MDCG guidance provision. Sections that do not trace come out. Claims that cannot be supported by appraised data come out. Narrative flourishes that do not contribute to GSPR analysis come out.

What survives is a CER that is shorter, sharper, and easier for the Notified Body to review than the default over-written version. A CER that is 80 disciplined pages of traceable analysis is a better CER than 300 pages of narrative that buries the argument. Notified Body reviewers do not reward volume. They reward clarity, traceability, and methodological rigour.

The Evidence Pass runs inside the CER project the same way it runs inside the broader clinical evaluation strategy. Literature first, equivalence second under MDCG 2020-5 where it genuinely applies, clinical investigations under EN ISO 14155:2020+A11:2024 for the gaps the first two sources cannot close. The CER is where the output of the Evidence Pass is documented and defended.

## Reality Check. Where do you stand?

1. Does your CER reference a pre-specified clinical evaluation plan, and do the appraisal criteria in the CER match the ones in the CEP word for word?
2. Is the intended purpose in the CER identical to the wording on the label and in the IFU, down to the sentence?
3. Do you have a GSPR traceability table that maps each clinical GSPR in Annex I to the specific appraised data supporting it?
4. If you claim equivalence, does your equivalence analysis address the technical, biological, and clinical dimensions separately and in full, per MDCG 2020-5?
5. For equivalence claims on implantable or Class III devices, do you have documented sufficient levels of access to the clinical data of the equivalent device?
6. Is every clinical investigation cited in the CER conducted or reported under EN ISO 14155:2020+A11:2024?
7. Does the CER reference the risk management file under EN ISO 14971:2019+A11:2021, and are the residual risks in the risk file consistent with the benefit-risk conclusion in the CER?
8. Does the PMCF plan name the specific uncertainties the CER has left open, and does it define activities proportionate to those uncertainties?
9. For a Class III or implantable device, is the CER update cadence documented as at least annual in line with Article 61(3)?
10. Can you hand the CER to a Notified Body reviewer today and defend every section by pointing to a specific MDR article, annex paragraph, or MDCG provision?

## Frequently Asked Questions

**What is a clinical evaluation report (CER) under MDR?**
The CER is the document that presents the output of the clinical evaluation process at the point of conformity assessment. Under MDR Article 61(12) and Annex XIV Part A paragraph 4, the CER documents the scope, the data identified from literature, equivalence, and clinical investigations, the appraisal and analysis of that data against the relevant general safety and performance requirements, and the conclusions on safety, performance, clinical benefits, and benefit-risk. It sits inside the Annex II technical documentation and is reviewed by the Notified Body during conformity assessment.

**Is there a mandatory CER template under MDR?**
No. MDR Article 61 and Annex XIV Part A specify required content, not a rigid template. MEDDEV 2.7/1 Rev 4 (June 2016) provides a structural format that many manufacturers and Notified Bodies still use as a reference, updated where MDR text takes precedence. The test is whether the CER covers every element required by Annex XIV Part A, not whether it follows a specific chapter numbering.

**How long should a CER be?**
There is no required length. A well-built CER for a lower-risk device with a tightly defined intended purpose and strong literature support can be 40 to 80 pages. A CER for a novel Class III implantable device with multiple clinical investigations can run several hundred pages. Length is a consequence of scope, not a target. Notified Body reviewers do not reward volume; they reward traceable methodology.

**What is the difference between the CEP and the CER?**
The clinical evaluation plan (CEP) is the plan written before data is collected. It specifies scope, methods, appraisal criteria, and acceptance thresholds in advance. The clinical evaluation report (CER) is the report written after the process has been executed, documenting what was done against the CEP and presenting the conclusions. A CER without a pre-specified CEP is methodologically indefensible.

**How often must the CER be updated?**
Under MDR Article 61(3), the clinical evaluation and its documentation must be updated throughout the life cycle of the device with data from the PMCF plan and the PMS plan. For Class III and implantable devices, Article 61(6) requires the CER to be updated at least annually with new clinical data. For lower-risk devices, the update frequency is defined in the PMS and PMCF plans, proportionate to the risk and the novelty of the device.

**Do Notified Bodies use MEDDEV 2.7/1 Rev 4 to review CERs?**
Many Notified Body reviewers still use MEDDEV 2.7/1 Rev 4 (June 2016) as a structural reference for what a well-formed CER looks like, because the MDR does not prescribe a template. Where MDR text and the MEDDEV diverge, the MDR takes precedence. For equivalence specifically, MDCG 2020-5 (April 2020) is the authoritative MDR-era interpretation and supersedes the older MEDDEV equivalence approach.

**What is the single most common reason a CER fails Notified Body review?**
In our experience, it is the combination of missing GSPR traceability and reverse-engineered appraisal criteria. The CER presents a body of data, concludes that the device is safe and effective, and never shows which specific clinical GSPR each piece of data supports. The reviewer cannot see the argument and the file comes back with clinical findings. The fix is a GSPR traceability table and a CEP written before the data collection starts, not after.

## Related reading

- [MDR Article 61 Clinical Evidence Requirements for Startups](/blog/mdr-article-61-clinical-evidence-requirements-startups) – the article-level walkthrough of the legal basis for the CER.
- [What Is Clinical Evaluation Under MDR?](/blog/what-is-clinical-evaluation-under-mdr) – the Cat 3 pillar explaining the clinical evaluation process the CER documents.
- [MDR Article 61 Clinical Evaluation Requirements](/blog/mdr-article-61-clinical-evaluation-requirements) – the paragraph-by-paragraph breakdown of Article 61.
- [Clinical Evaluation vs Clinical Investigation](/blog/clinical-evaluation-vs-clinical-investigation) – the distinction that frames which data sources the CER draws on.
- [MDR Annex XIV Part A: Clinical Evaluation Explained](/blog/mdr-annex-xiv-part-a-clinical-evaluation) – the annex walkthrough that sits directly underneath the CER structure.
- [How to Write a Clinical Evaluation Plan (CEP) Under MDR](/blog/write-clinical-evaluation-plan-cep-mdr) – the upstream plan every credible CER must reference.
- [Systematic Literature Review for Clinical Evaluation](/blog/systematic-literature-review-clinical-evaluation) – the method behind the literature section of the CER.
- [Appraisal of Clinical Data Under MDR](/blog/appraisal-clinical-data-mdr) – the appraisal stage of the four-stage data treatment.
- [How to Update Your Clinical Evaluation Report](/blog/update-clinical-evaluation-report-mdr) – the lifecycle maintenance of the CER under Article 61(3).
- [Biggest Clinical Evaluation Mistakes Startups Make Under MDR](/blog/biggest-clinical-evaluation-mistakes-startups-mdr) – the expanded catalogue of CER failure patterns.
- [How Notified Bodies Review Clinical Evaluation Reports](/blog/notified-body-review-clinical-evaluation-report) – the reviewer's sequence from the other side of the table.
- [The Subtract to Ship Framework for MDR Compliance](/blog/subtract-to-ship-framework-mdr) – the methodology pillar, including the Evidence Pass referenced in this post.

## Sources

1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 61 (clinical evaluation), Annex I (general safety and performance requirements), Annex II (technical documentation), Annex III (post-market surveillance), Annex XIV Part A (clinical evaluation), Annex XIV Part B (post-market clinical follow-up). Official Journal L 117, 5.5.2017.
2. MDCG 2020-5. Clinical Evaluation. Equivalence: A guide for manufacturers and notified bodies, April 2020.
3. MEDDEV 2.7/1 revision 4. Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC, June 2016 (legacy structural reference; MDR text takes precedence where they diverge).
4. EN ISO 14155:2020 + A11:2024. Clinical investigation of medical devices for human subjects. Good clinical practice.
5. EN ISO 14971:2019 + A11:2021. Medical devices. Application of risk management to medical devices.

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*This post is part of the Clinical Evaluation & Clinical Investigations series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. The CER is the document a Notified Body will read most carefully in your clinical file. Building it against the four-stage data treatment and the specific Annex XIV Part A requirements is the difference between a clean clinical review and a round of findings that costs months of runway.*

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*This post is part of the [Clinical Evaluation & Investigations](https://zechmeister-solutions.com/en/blog/category/clinical-evaluation) cluster in the [Subtract to Ship: MDR Blog](https://zechmeister-solutions.com/en/blog). For EU MDR certification consulting, see [zechmeister-solutions.com](https://zechmeister-solutions.com).*