Clinical Evaluation Reports — Meeting EU MDR’s Toughest Requirement
The Clinical Evaluation Report (CER) is often the make-or-break element of an EU MDR technical file. RABT Global’s clinical scientists prepare CERs that meet Notified Body scrutiny — with rigorous methodology, strong clinical evidence, and full Annex XIV compliance.
Discuss your device’s clinical evidence landscape with our CER specialists. We’ll scope your CER and identify the most efficient evidence strategy.
A Clinical Evaluation Report (CER) is a systematic, planned process to continuously generate, collect, analyse, and assess clinical data pertaining to a medical device — to verify the clinical safety and performance of the device throughout its lifecycle.
Under EU MDR 2017/745, the CER is a mandatory component of every medical device’s technical documentation (Annex II). It must be prepared by suitably qualified clinical scientists and updated as new clinical data becomes available.
Who needs a CER? ALL medical devices placed on the EU market under EU MDR 2017/745 — from Class I devices (manufacturer-held) to Class III devices (reviewed by Notified Body and subject to the highest scrutiny).
Our CER Preparation Process — 5 Stages
RABT GLOBAL’S 5-STAGE CER PROCESS
CER Scoping & Evidence Strategy
Define the device’s intended purpose, identify applicable clinical data sources (literature, clinical experience, clinical investigations), and agree the evidence strategy — including whether equivalence approach is viable.
Systematic Literature Search
Conduct systematic, documented literature searches across MEDLINE (PubMed), Embase, Cochrane, and other relevant databases. Screen results for relevance. Document search protocol and search reports per MDCG 2020-6.
Data Appraisal & Analysis
Critically appraise all included studies using validated appraisal tools. Tabulate appraisal findings. Analyse clinical data for safety and performance evidence. Assess clinical residual risks.
CER Writing & Quality Review
Prepare the full CER document to EU MDR Annex XIV structure. Clinical scientist authoring plus independent clinical review. Regulatory review for EU MDR compliance. Quality sign-off.
PMCF Plan & SSCP (if required)
Develop the Post-Market Clinical Follow-up (PMCF) plan linked to the CER conclusions. For Class III / applicable Class IIb: prepare Summary of Safety and Clinical Performance (SSCP) for EUDAMED publication.
Old MDD CER vs EU MDR CER — What Changed
| Factor | MDD CER (Old) | EU MDR CER (Current — Annex XIV) |
|---|---|---|
| Clinical Evidence Standard | Literature review generally sufficient | Higher evidence standard — equivalence criteria much stricter; clinical investigations may be required for novel/higher-risk devices |
| Equivalence Device Approach | Broadly accepted with limited justification | Very strict equivalence criteria (technical, biological, clinical) — difficult to sustain without contractual access to the predicate manufacturer’s data |
| Literature Search Methodology | Basic literature search acceptable | Systematic, documented literature search across multiple databases (MEDLINE, Embase, Cochrane) required per MDCG 2020-6 |
| PMCF Requirement | Optional for most devices | Mandatory Post-Market Clinical Follow-Up (PMCF) plan required for all devices; PMCF report as part of periodic CER updates |
| SSCP | Not required | Summary of Safety and Clinical Performance (SSCP) required for Class III and some Class IIb devices — publicly available on EUDAMED |
| Update Frequency | No formal update schedule | Annual updates (Class III) or as significant new data emerges; full review at least every 2–5 years depending on class |
EU MDR CER Components — Annex XIV Requirement Checklist
Section 1: Scope of the Clinical Evaluation
Section 2: Clinical Background and Current Knowledge / State of the Art
Section 3: Data from Pre-Clinical Studies and Testing
Section 4: Clinical Data from Literature (Systematic Literature Review)
Section 5: Clinical Data from Clinical Experience (Complaints, PMS, Post-Market Studies)
Section 6: Clinical Data from Clinical Investigations (if applicable)
Section 7: Equivalence Assessment (if equivalence approach used)
Section 8: Analysis of Clinical Data — Safety and Performance
Section 9: Conclusions on Clinical Safety and Performance
Section 10: References
Annex: Literature Search Protocol and Search Report
Appraisal Data: Literature appraisal tables with study assessment
Clinical Evaluation Reports — FAQs
A: CER preparation timeline depends on device complexity, evidence availability, and equivalence approach. A straightforward CER for a lower-risk device with substantial pre-existing clinical literature can take 8–12 weeks. Complex Class III devices with limited literature or novel technology typically require 16–24 weeks including literature search, data appraisal, and full CER authoring. RABT Global provides a specific timeline estimate during the CER scoping consultation.
A: Equivalence is possible under EU MDR, but the criteria are strict (Annex XIV, Part A, Section 3). Technical, biological, and clinical equivalence must be demonstrated. Critically: if you do not manufacture the predicate device, you must have contractual access to the predicate’s technical documentation — which is often unavailable. RABT Global assesses equivalence viability at the CER scoping stage and advises on alternative evidence strategies where equivalence is not sustainable.
A: RABT Global’s CER team consists of clinical scientists with medical or biomedical science qualifications (MD, PhD, MSc) combined with regulatory affairs expertise. All CERs are authored by qualified clinical evaluators as required by EU MDR Annex XIV — not by regulatory writers without clinical science background.
A: CER update frequency depends on device class and new clinical evidence: Class III devices — annual updates required. Class IIb implantables — at minimum every 2 years. Class IIa and lower — updated when new significant clinical evidence (literature, complaints, PMS data, PMCF reports) becomes available. RABT Global provides ongoing CER maintenance as part of our post-market surveillance retainer service.
Get a CER That Passes Notified Body Scrutiny — First Time
Expert Clinical Evaluation Report services from RABT Global’s qualified clinical scientists. Annex XIV compliant. PMCF planning included. Bundled with SSCP where required.