TemplateEU

EU Medical Device Regulation (MDR) 2017/745 CER Template

Write a Clinical Evaluation Report you can defend.

This template focuses on traceability: claims to evidence to appraisal to conclusions to PMS/PMCF updates.

Back to main artifact Review sources

Author

Sorena AI

Published

Feb 22, 2026

Updated

Feb 22, 2026

Sections

Structured answer sets in this page tree.

Primary sources

Cited legal and guidance references.

Publication metadata

Sorena AI

Published Feb 22, 2026

Updated Feb 22, 2026

Overview

A good CER is not long - it is reviewable. The fastest CERs to approve are structured, explicit about methods, and link each clinical claim to specific data and appraisal outcomes. Use this template as a copy-ready outline and as a review checklist before internal sign-off or notified body submission.

Section 1

How to use this CER template (quick rules that prevent rework)

Write one CER per device family and intended purpose (not per marketing page). Keep a CER change log and tie it to change control and PMS signals.

If you rely on equivalence, create a separate equivalence dossier and reference it consistently from the CER.

Keep methods explicit: search strategy, appraisal criteria, and synthesis logic must be repeatable.
Use traceability tables: claims and hazards and clinical endpoints and evidence sources and conclusions.
Document limitations and residual uncertainties, and tie them to PMCF/PMS actions.

Recommended next step

Keep EU Medical Device Regulation (MDR) 2017/745 CER Template in one governed evidence system

SSOT can take EU Medical Device Regulation (MDR) 2017/745 CER Template from reusing this material inside a governed evidence system to a reusable workflow inside Sorena. Teams working on EU Medical Device Regulation (MDR) 2017/745 can keep owners, evidence, and next steps aligned without copying this guide into separate documents.

Evidence system

Open SSOT for EU Medical Device Regulation (MDR) 2017/745 CER Template

Start from EU Medical Device Regulation (MDR) 2017/745 CER Template and keep documents, evidence, and control records in one governed system.

Explore next step

Talk to Sorena

Talk through EU Medical Device Regulation (MDR) 2017/745

Review your current process, evidence gaps, and next steps for EU Medical Device Regulation (MDR) 2017/745 CER Template.

Explore next step

Section 2

CER structure (copy-ready outline)

Use the headings below as your CER backbone. Add annexes for evidence tables and appraisal worksheets to keep the main CER readable.

Goal: a reviewer can answer what is the claim, what is the evidence, and why is it sufficient without hunting.

1) Administrative: device family, UDI/BUDI identifiers (where available), versions, authors/reviewers, approvals, change log.
2) Device + intended purpose: indications, contraindications, user groups, use environment, variants/accessories, essential performance.
3) Clinical claims and endpoints: what you claim, how it will be measured, and acceptability thresholds.
4) State of the art: current clinical practice and alternatives; baseline risks/benefits and expected performance.
5) Clinical evaluation plan summary: data sources, search strategy, inclusion/exclusion criteria, appraisal method, and synthesis approach.
6) Clinical data identification: literature search results, clinical investigations, registries, PMS data, complaints and serious incidents.
7) Appraisal: quality and relevance assessment per data source; bias and limitations; comparability to your device and indications.
8) Analysis and conclusions: performance and safety conclusions per claim and per risk; benefit-risk rationale; residual risks.
9) Equivalence (if used): criteria, evidence, data access justification, and why equivalence remains valid after changes.
10) Residual uncertainty + PMCF/PMS updates: what's unknown, how you will monitor, update triggers, and reporting cadence.
11) References and annexes: appraisal worksheets, evidence tables, device changes history, mapping to GSPR checklist.

Section 3

CER quality checklist (use as an internal review gate)

Use these questions as acceptance criteria before you approve a CER. If the answer is it depends the CER should contain the missing reasoning and evidence links.

Practical tip: reviewers should be able to trace each clinical claim to at least one primary evidence summary and a clear appraisal outcome.

Do intended purpose and claims match the label/IFU, marketing, and UI outputs exactly?
Is the clinical literature search strategy defined (databases, terms, dates, inclusion/exclusion) and repeatable?
Are appraisal criteria explicit and applied consistently (not a vague statement that only the best papers were selected)?
Are conclusions tied to endpoints and acceptability thresholds (not vague appears-safe statements)?
Do CER conclusions match risk management conclusions and GSPR evidence links (no contradictions)?
Are residual uncertainties documented with PMCF/PMS actions and time-bound update triggers?
If equivalence is used: is access to comparable device data demonstrated and is change impact addressed?