MDR Article 61 · Annex XIV Part A · Interactive review
Clinical evaluation report checklist
Test whether the CER tells one complete, traceable and clinically defensible story.
Review each checkpoint, record a finding or document reference, and issue a clean readiness report. Your draft is stored only in this browser and is not sent to MDRC.
Start the review ↓48 checkpoints · 8 review sections
Review details
Identify the report before reviewing it
Only completed fields are carried into the issued report. The device name is required.
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CER review
Follow the evidence from source to conclusion
Use Meets, Action needed or Not applicable. Add a document reference, finding or corrective action wherever it helps the review.
The CER has a unique identifier, version, date, approval status and controlled-document owner
The report should be traceable within the QMS and distinguishable from earlier, superseded and draft versions.
The device name, model, type, variants and Basic UDI-DI are identified as applicable
The report should state exactly which configurations are covered and which are outside its conclusions.
The manufacturer, authorised representative, SRN and certificate details are provided where applicable
Administrative particulars should match the current technical documentation and certification records.
The risk class, classification rule, applicable codes and conformity-assessment context are stated
Make any notified-body involvement, sampling basis or special assessment pathway clear.
The purpose, scope, lifecycle stage and type of clinical-evaluation review are defined
Clarify whether the CER supports initial certification, an update, recertification, a design or indication change, or another decision.
The revision history identifies material changes, previous conclusions and unresolved actions
A reviewer should be able to see what changed since the previous CER and why the conclusions remain valid or were revised.
The device, key components, operating principle and mode of action are adequately described
Include clinically relevant hardware, software, materials, substances and distinguishing technological features.
The intended purpose, indications and intended clinical benefits are stated without ambiguity
The wording should be precise enough to determine what safety, performance and benefit evidence is required.
Target populations, intended users, use environments and relevant clinical workflows are defined
Address age, disease severity, subgroups, professional or lay use, training and the care setting.
Contraindications, warnings, limitations and reasonably foreseeable misuse are addressed
The clinical evaluation should cover every clinically significant restriction and risk-control condition.
Variants, accessories, compatible products and previous generations are mapped to the CER scope
Explain whether differences affect clinical safety, performance, benefit or the applicability of evidence.
Novel features, new indications and clinical claims are identified and consistently presented
Check the CER against the IFU, labelling, SSCP where applicable, technical documentation and promotional claims.
The approved clinical evaluation plan is identified and the CER follows its methods
Any deviation from the plan should be visible, justified and assessed for its effect on the conclusions.
Clinical questions, data sources, search cut-off dates and evaluation methods are defined
The methodology should allow another competent reviewer to understand how the evidence base was assembled.
The GSPR requiring support from relevant clinical data are identified and mapped
The CER should show how clinical evidence supports the applicable requirements in MDR Annex I.
Evaluator identities, roles, qualifications, experience and conflicts of interest are documented
The team should collectively cover clinical expertise, device technology, research methodology, literature retrieval and regulatory requirements.
Selection, appraisal and analysis methods are prespecified, appropriate and consistently applied
Confirm that inclusion criteria, relevance assessment, quality appraisal and evidence weighting are transparent.
Favourable and unfavourable data are considered objectively, with duplication and bias controlled
The report should not omit negative findings, repeatedly count the same patients or rely on selective interpretation.
The disease, natural history, clinical pathway and available alternatives are adequately described
The state of the art should reflect current accepted clinical practice, relevant technologies and patient management.
Current safety, performance and benefit-risk benchmarks are defined
Benchmarks should be appropriate to each indication, population and clinically meaningful outcome.
The literature searches are reproducible and cover the device, equivalent devices and state of the art as applicable
Databases, sources, dates, search strings, language limits and update searches should be reported.
The selection process and reasons for exclusion are documented
Provide a transparent screening trail, address duplicates and distinguish device evidence from background literature.
Each relevant publication is appraised for methodological quality, relevance and contribution
The report should explain how design, bias, population, endpoints and applicability affect evidentiary weight.
Any equivalence claim demonstrates technical, biological and clinical equivalence with sufficient data access
Do not combine characteristics from several products to create equivalence, and explain why identified differences are not clinically significant.
All relevant clinical investigations of the device are identified and linked to their reports
Include pre-market, post-market, completed, terminated and relevant ongoing investigations.
Study design, objectives, populations, endpoints, sample size, follow-up and statistics are adequately described
The description should allow the reader to judge whether each investigation can answer the intended clinical question.
Ethics, regulatory compliance, GCP, protocol deviations and potential bias are addressed
Explain how deviations, missing controls, confounding and other limitations affect confidence in the findings.
Safety and performance results are complete, including adverse events, withdrawals and missing data
Present denominators, follow-up duration, subgroup findings and statistical uncertainty where relevant.
Registries, real-world data, usability information, complaints and other relevant clinical sources are evaluated
Describe their quality, limitations, representativeness and contribution rather than merely listing them.
The clinical-investigation strategy and any exemption or Article 61(10) route are specifically justified
The justification should address the device, interaction with the body, intended performance, claims, risks and available clinical evidence.
PMS data are current through the stated cut-off date and appropriately analysed
The CER should identify exposure denominators, data periods, sources and limitations where available.
Complaints, incidents, serious incidents, trend reports and FSCAs are fully addressed
Explain rates, severity, root causes, recurrence and whether signals alter known risks or clinical conclusions.
The current PMCF plan, objectives and activities are identified
Where PMCF is considered not applicable, the CER should contain a device-specific and evidence-based justification.
PMCF findings, data quality, deviations and unresolved questions are integrated
Include completed activities, ongoing activities and justified departures from the PMCF plan.
Post-market findings are reflected in risk management, labelling, SSCP and other technical documentation
The report should explain both changes made and decisions that no change was necessary.
New signals, evidence gaps, corrective actions, milestones and update triggers are clearly defined
Make clear what will be monitored, who owns the action, when it is due and what result requires escalation.
Each indication, clinical claim, intended benefit and relevant GSPR is supported by an identifiable evidence route
An evidence map should make unsupported or only partially supported claims immediately visible.
The analysis weighs evidence quality, quantity, relevance, consistency and limitations
Explain why stronger and weaker data receive their assigned contribution to the overall conclusions.
Clinical safety is evaluated qualitatively and quantitatively against residual risks and side effects
Address frequency, severity, duration, reversibility, uncertainty and risk-control effectiveness.
Clinical performance and intended clinical benefits are demonstrated through relevant outcome parameters
Distinguish technical performance from clinically meaningful benefit and justify any surrogate outcomes.
The benefit-risk determination is acceptable for each indication, population and use condition
Compare the device with the current state of the art and address clinically relevant subgroups separately where necessary.
The level of clinical evidence is sufficient, and remaining gaps and uncertainties have proportionate actions
Link unresolved issues to claim restrictions, risk controls, clinical investigations, PMCF or other defined measures.
The conclusions directly address the intended purpose, claims and scope without unsupported extrapolation
State what is demonstrated, for whom, under which conditions and with what important limitations.
CER conclusions are consistent with the risk management file, IFU, labelling and user training
Benefits, risks, contraindications, warnings, residual risks and risk-control measures should align.
The SSCP and promotional or sales information are consistent with the clinical evidence where applicable
Public-facing statements should not be broader, stronger or more certain than the CER conclusions.
The next CER update, PMS and PMCF milestones and event-driven triggers are defined
Update timing should reflect device risk, novelty, evidence gaps, market experience and emerging signals.
References, appendices, evidence tables and linked records are complete and traceable
A competent reviewer should be able to locate the source behind each important statement and conclusion.
The CER is signed, dated and approved, with evaluator declarations and final actions controlled
Confirm the required approvals, independence statements, action owners and closure of material review findings.
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Methodological basis
The checklist tests the complete MDR evidence chain
MDCG documents support consistent application of the MDR but are not legally binding. Always assess device-specific requirements.
