Six documents covering EU MDR clinical evaluation end-to-end — from Clinical Evaluation Plan through PMCF report. Built for Article 61 + Annex XIV compliance.
Instant download. For RA/QA at EU MDR device companies.
Notified bodies are rejecting Clinical Evaluation Reports at record rates. The most common failures: Clinical Evaluation Plan not submitted before the CER, equivalent device comparison missing the technical/biological/clinical triad per MEDDEV 2.7/1 Rev 4, and literature reviews without a documented systematic search protocol.
Under EU MDR, the CER is not optional and not a summary — it is a scientific document that must demonstrate clinical evidence proportionate to the device risk. Notified bodies now apply EUDAMED scrutiny to Class IIb and III CERs. The review process starts before submission with the CEP.
Structured in the order you'd build the clinical evaluation file.
EU MDR Article 61 + Annex XIV compliant CER structure covering device description, clinical background, equivalence assessment, clinical data appraisal, clinical evaluation conclusions, and benefit-risk determination. Pre-formatted for notified body review.
Post-Market Clinical Follow-Up plan and report per MDR Annex XIV Part B. Covers PMCF objectives, rationale, methods (registry, PMCF study, literature survey), data collection intervals, and reporting obligations to the notified body.
Structured worksheet for demonstrating clinical, biological, and technical equivalence per MDR Article 61(1) and MEDDEV 2.7/1 Rev 4. Includes device-by-device comparison tables, equivalence justification fields, and gap documentation for non-equivalent devices.
Systematic literature search protocol per MEDDEV 2.7/1 Rev 4 — search strategy, databases (PubMed, EMBASE, Cochrane), inclusion/exclusion criteria, data extraction template, GRADE appraisal, and evidence weighting table. Required for every CER.
Clinical Evaluation Plan per MDR Annex XIV Part A — defines the scope, intended purpose, clinical claims, benefit-risk profile, equivalence approach, and data sources. The CEP is reviewed by the notified body before the CER is accepted.
Line-by-line compliance checklist against MDR Annex XIV Parts A and B. Maps every requirement to your CEP, CER, and PMCF documents. Identifies gaps before notified body submission. Includes NB scrutiny trigger criteria.
All templates reflect the 2021 EU MDR Annex XIV framework — CEP before CER, PMCF obligations, and the clinical evidence requirements notified bodies now enforce under IVDR and MDR.
The two most common CER rejection reasons: inadequate equivalent device justification and missing systematic literature protocol. Both covered with structured templates and worked examples.
CER writing is one of the most expensive outsourced regulatory activities — €5K–€25K per report. Start with the right framework for in-house or consultant-supported evaluation.
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“Our notified body rejected the first CER submission because the clinical evaluation plan wasn't structured per Annex XIV Part A. This CEP template is built exactly to that structure — resubmitted and accepted within 8 weeks. Would have saved us three months if I'd had it from the start.”
Liesel V., Regulatory Affairs Director — Class IIb Active Medical Device Manufacturer, Netherlands
“The equivalent device worksheet is the most useful thing in here. Our predicate was an MDD-cleared device from a competitor and documenting the technical equivalence point-by-point per Article 61 was genuinely unclear to us. This structured the entire argument correctly.”
Mark C., Senior QA Manager — Orthopaedic Device Company, Germany
“I review CERs as a technical reviewer for a UK Approved Body. The majority of rejected CERs fail on literature methodology — no systematic search protocol, no GRADE appraisal, no documented inclusion/exclusion rationale. The literature review protocol in this kit addresses every one of those failure points.”
Dr. Patricia H., Technical Reviewer & RA Consultant — Former UKRP / Notified Body Contractor
Primarily Article 61 (clinical evaluation), Article 83–86 (PMS/PMCF), and Annex XIV (Parts A and B). The CER template also references Annex I (General Safety and Performance Requirements) as required for benefit-risk documentation.
Under EU MDR Article 61(5), equivalence to a competitor's device is permitted but requires a contract giving access to the technical documentation. The equivalence worksheet documents the technical, biological, and clinical comparison — but you still need that access agreement. This is a common MDR blocker; the worksheet makes the documentation argument correct assuming you have access.
The Clinical Evaluation Plan (CEP) defines your approach — intended purpose, clinical claims, data sources, equivalence strategy — and is submitted first for notified body review. The Clinical Evaluation Report (CER) is the completed evaluation document with actual clinical evidence, literature appraisal, and conclusions. The CEP gates the CER review.
Yes, with caveats. Class IIa and IIb CERs using general equivalence follow this framework directly. Class III and implantable devices (Article 61(4)) require clinical investigations and face NB scrutiny via EUDAMED. The templates include Class III-specific fields but clinical investigation planning is a separate workstream.
No. These are practitioner reference templates built around current EU MDR requirements and MEDDEV 2.7/1 Rev 4. Your specific device, classification, and notified body relationship require review by qualified regulatory professionals. Use these as frameworks, not final submissions.
Start with the CEP. Build the clinical evidence argument. Document PMCF obligations. Get through the NB review cycle faster.