Clinical Evaluation Report (CER)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
A Clinical Evaluation Report is the documented output of a device manufacturer’s clinical evaluation — the systematic, ongoing process of collecting, appraising, and analyzing clinical data to verify safety, performance, and clinical benefit, and to confirm the acceptability of the device’s risk-benefit ratio throughout its lifecycle. It underpins the technical documentation reviewed by the Notified Body under EU MDR.
Clinical evaluation draws on multiple data streams: clinical investigations of the device itself, published literature on the device or an equivalent device, and postmarket surveillance and PMCF data once the device is on the market. Where a manufacturer relies on equivalence to another device rather than its own clinical investigation, MDR sets a demanding bar for demonstrating technical, biological, and clinical equivalence.
The CER is not a one-time deliverable — it must be updated throughout the device’s lifecycle at a frequency proportionate to risk, incorporating new literature, postmarket surveillance findings, and PMCF results, and is one of the documents a Notified Body reviews at each periodic surveillance audit for higher-risk device classes.
- —Documents the systematic clinical evaluation of safety, performance, and risk-benefit
- —Draws on clinical investigations, literature, and postmarket/PMCF data
- —Equivalence claims to another device require demonstrating technical, biological, and clinical equivalence
- —Living document updated proportionate to risk, reviewed at Notified Body surveillance audits
EU MDR 2017/745 Article 61 and Annex XIV Part A; MEDDEV 2.7/1 Rev. 4 (clinical evaluation methodology)
Frequently asked questions
What is Clinical Evaluation Report (CER)?
A Clinical Evaluation Report is the documented output of a device manufacturer’s clinical evaluation — the systematic, ongoing process of collecting, appraising, and analyzing clinical data to verify safety, performance, and clinical benefit, and to confirm the acceptability of the device’s risk-benefit ratio throughout its lifecycle. It underpins the technical documentation reviewed by the Notified Body under EU MDR.
Which regulations cover Clinical Evaluation Report (CER)?
EU MDR 2017/745 Article 61 and Annex XIV Part A; MEDDEV 2.7/1 Rev. 4 (clinical evaluation methodology)