Which clinical data count toward the CER?

Under Art. 61 and Annex XIV of the MDR, own preclinical and clinical investigations, systematically searched literature data on equivalent devices, and post-market data from PMS and PMCF may be used. The methodological quality of each data source must be documented through a level-of-evidence appraisal.

How often must the CER be updated?

Annex XIV of the MDR requires continuous updating with new PMS and PMCF data. For implants and Class III devices, updating is required at least annually; for lower classes it is performed on a risk-based and event-driven basis whenever substantial new data become available.

What is the SSCP needed for?

Under the MDR, the Summary of Safety and Clinical Performance (SSCP) must be prepared for implantable devices and Class III devices. It summarizes the key safety and performance data from the CER in a form accessible to users and patients and is published in EUDAMED.

How does the CER relate to PMS and PMCF?

The CER provides the acceptance criteria and the outstanding evidence needs that are closed through Post-Market Clinical Follow-up (PMCF). The PMS data collected in the market under Art. 83–86 of the MDR feed back into the updating of the CER; MDCG 2020-13 describes how the notified body assesses this integration.

Which clinical data are genuinely sufficient for your MDR class so that the Clinical Evaluation Report passes the notified body review?

Q: When is an own clinical investigation required?

Under Art. 61 of the MDR, an own clinical investigation generally becomes necessary when no suitable equivalent device exists or when the literature data show gaps against the required safety and performance objectives. For implantable and Class III devices, own clinical investigations are required as a matter of principle.

Under Art. 61 of Regulation (EU) 2017/745 (MDR), the clinical evaluation is a prerequisite for every medical device carrying the CE marking. We prepare the Clinical Evaluation Report (CER) along the five-stage cycle of MEDDEV 2.7/1 Rev. 4: planning, data identification, appraisal, analysis, report. The most common reason for findings is not a lack of evidence but an equivalence rationale that does not hold up without access to the technical documentation of the comparator device.

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Overview

What does the MDR require of the clinical evaluation?

CER preparation along the five-stage cycle of MEDDEV 2.7/1 Rev. 4 · MDR (EU) 2017/745, MDCG 2020-13

Last updated: 2026-06-13

Under Regulation (EU) 2017/745 (MDR), the requirements for the demonstration of equivalence and for literature appraisal have tightened considerably compared with the MDD 93/42/EEC. Four points where Clinical Evaluation Reports most frequently fail in the notified body review:

Data acceptability: Which clinical data (own investigations, literature, post-market data) the notified body accepts for the given risk profile depends on the device class under MDR and must be justified in advance in the Clinical Evaluation Plan.
Equivalence: Under Art. 61 and Annex XIV of the MDR, the equivalence route requires demonstration of clinical, technical, and biological comparability and, as a rule, presupposes access to the technical documentation of the comparator device, a hurdle that did not exist in this form under the MDD.
Literature methodology: The systematic literature search must follow a documented database and search strategy so that selection bias is ruled out and the level of evidence can be appraised in a traceable manner.
Interfaces: Under Annex XIV of the MDR, the CER must be integrated with the PMS plan under Art. 83–86 and with Post-Market Clinical Follow-up (PMCF); a missing feedback loop leads to findings in the surveillance audit.

Services

How we support you

Clinical Evaluation Plan (CEP)

Preparation of the Clinical Evaluation Plan as the basis for systematic appraisal: definition of scope, determination of the equivalence strategy, search strategy, and the acceptance criteria for clinical safety and performance. The deliverable is an approved CEP that sets the assessment framework for the subsequent CER.

Systematic literature search

Complete database search following the protocol defined in the CEP with a documented search strategy. The deliverable is a traceable search protocol with documented inclusion and exclusion rationale, level-of-evidence appraisal, and structured extraction of the relevant publications.

Clinical Evaluation Report (CER)

CER preparation in accordance with MEDDEV 2.7/1 Rev. 4 as well as Art. 61 and Annex XIV of the MDR. The deliverable is an audit-ready report comprising the device description, equivalence argumentation, clinical evidence synthesis, and residual-risk assessment, aligned with risk management.

SSCP & PMCF integration

Preparation of the Summary of Safety and Clinical Performance (SSCP) for implantable and Class III devices, plus establishing the feedback loop between the CER, the PMS plan under Art. 83–86, and PMCF in accordance with MDCG 2020-13. The deliverable is a maintainable CER with defined PMCF data sources.

How we work together

Strategy Consulting

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When clarity on strategy and priorities is missing: market entry, portfolio strategy, digitalization roadmap or regulatory realignment.

Project Consulting

Your project. Our responsibility.

When capacity and expertise are missing: resource bottleneck, audit preparation or production ramp-up.

Hybrid Consulting

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When direction and delivery power are needed at once: transformations, approval projects, market entry.

What it comes down to

The clinical evaluation under Art. 61 of the MDR is not a single document but a cycle whose sequence determines the outcome. It begins with the Clinical Evaluation Plan: only once scope, equivalence strategy, and acceptance criteria are fixed is the systematic literature search unbiased and the subsequent appraisal robust. Anyone who skips the plan and writes the Clinical Evaluation Report straight away formulates the criteria retrospectively, and that is exactly what gets flagged in the notified body review. The second critical point is equivalence: it is the fastest route to evidence, but under the MDR the most fragile, because the demonstration as a rule does not hold up without access to the technical documentation of the comparator device.

The real bottleneck lies earlier than most projects plan for. If it only emerges while writing the CER that the literature data show gaps against the required safety and performance objectives and that no suitable equivalent device exists, the only option left is an own clinical investigation, and by then there is no time for it. That is why we clarify the evidence needs in the CEP before the search begins, and integrate the CER with PMS under Art. 83–86 and PMCF under Annex XIV from the outset. This turns the clinical evaluation into a maintainable system rather than a document that becomes a gap again at the next surveillance audit.

Our approach

Step

Result

Scoping & Clinical Evaluation Plan

Approved CEP defining scope, equivalence strategy, search strategy, and acceptance criteria as the assessment framework.

Data identification

Documented database search and identified clinical data sources from literature, own investigations, and post-market data.

Appraisal

Level-of-evidence appraisal of the data and a methodologically justified equivalence argumentation.

Analysis

Evidence synthesis against the acceptance criteria, reconciliation with risk management, and residual-risk assessment.

Report & interfaces

Audit-ready CER in accordance with MEDDEV 2.7/1 Rev. 4, integrated with the PMS plan and PMCF, including the SSCP where required.

Common pitfalls

Where projects commonly fail

Equivalence is claimed without access to the technical documentation of the comparator device.

Art. 61 and Annex XIV of the MDR require demonstration of clinical, technical, and biological comparability; a mere reference to publicly available data does not satisfy the notified body.

The literature search is conducted without a pre-approved search protocol.

Without a documented database and search strategy, selection bias cannot be ruled out, and the level of evidence of the included publications cannot be traced in the review.

The CEP is missing or is adjusted retrospectively to fit the CER.

The acceptance criteria for safety and performance must be fixed before the appraisal; if they are formulated after the fact, the appraisal is not unbiased and is flagged in the audit.

The CER is treated as a one-off document.

Annex XIV of the MDR requires continuous updating with new PMS and PMCF data; without this feedback loop, a gap emerges that is flagged in the surveillance audit.

The clinical evaluation is started too late.

If the available evidence is insufficient and the equivalence route is closed off, there is no time left to generate own clinical data. This is the most common cause of serious delays in the MDR certification process.

FAQ

Frequently asked questions

Under Annex XIV of the MDR (EU) 2017/745, the Clinical Evaluation Plan (CEP) defines, in advance, the methodology, scope, and acceptance criteria for safety and performance. The Clinical Evaluation Report (CER) is the final report that summarizes the results of the literature search and data analysis against these criteria.

Sources

Regulation (EU) 2017/745 (MDR), primary text: Art. 61, Art. 83-86, Annex XIV
MEDDEV 2.7/1 Rev. 4, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies under Directives 93/42/EEC and 90/385/EEC
MDCG 2020-13, Clinical Evaluation Assessment Report Template
https://theentourage.de/clinical-medical-affairs/klinische-bewertung-mdr-meddev/ (existing page content, revised)

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Regulations & standards considered

Regulation (EU) 2017/745 (MDR)
MDR Art. 61 (Clinical Evaluation)
MDR Annex XIV (Clinical Evaluation & PMCF)
MDR Art. 83-86 (Post-Market Surveillance)
MEDDEV 2.7/1 Rev. 4 (Clinical Evaluation)
MDCG 2020-13 (Clinical Evaluation Assessment Report Template)
MDD 93/42/EEC (predecessor directive)

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