All terms
Clinical Evaluation Report
Documented assessment of clinical data demonstrating EU MDR conformity for a device.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
A CER systematically appraises and analyses clinical data to verify clinical safety, performance, and the clinical benefit-risk profile of a device under MDR Annex XIV. It must be updated throughout the device lifecycle. What the regulation says
The EU Medical Device Regulation (MDR) Annex XIV mandates the Clinical Evaluation Report (CER) as a critical document for demonstrating a device's safety and performance. This report systematically appraises and analyzes clinical data, encompassing data generated during preclinical development, clinical investigations, and post-market surveillance. The FDA requires similar documentation for demonstrating reasonable assurance of safety and effectiveness, often through premarket approval (PMA) applications, which include clinical data analysis.What this means in practice
MDR raised the clinical-evidence bar substantially over MDD: equivalence claims to other devices are tightly constrained, and post-market clinical follow-up (PMCF) feeds back into the CER.Examples
- A manufacturer of an orthopedic implant updates its CER with five years of post-market clinical follow-up data, demonstrating sustained long-term safety and performance in a larger patient population.
- During a Notified Body audit, a notified body reviewer requests to see the CER for a new diagnostic device and verifies that the clinical data analysis aligns with the device's intended use and claims.
- A company developing a novel software as a medical device (SaMD) submits a CER as part of its technical documentation, which includes a systematic review of scientific literature and data from a prospective clinical trial.
Common pitfalls
- •Failing to include a comprehensive search strategy for relevant clinical data can lead to an incomplete CER.
- •Not adequately justifying equivalence claims to a predicate device is a common pitfall.
- •Overlooking the continuous update requirement of the CER throughout the device lifecycle often results in non-compliance.
- •Poorly documented or insufficient PMCF data can weaken the conclusions of the CER.
- •Presenting a CER as a static document, rather than one that evolves with new clinical data, is a frequent mistake.
Frequently asked questions
The primary purpose of a CER is to demonstrate that a medical device achieves its intended performance without compromising the safety or health of patients, users, or other persons, as required by EU MDR Annex XIV.
Cross-references
Related terms
Shared paths + categoryStandards
ISO 14155
Good clinical practice for clinical investigations of medical devices.
Clinical Trials & Evidence
Regulatory
EU Medical Device Regulation(MDR)
Regulation (EU) 2017/745 governing medical devices in the European Union.
Post-Market
Post-Market Clinical Follow-up(PMCF)
Proactive collection of clinical data on a CE-marked device to confirm safety and performance.
Clinical & Trials
Real-World Evidence(RWE)
Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
Clinical Trials & Evidence · adjacent
Clinical & Trials
Risk-Based Monitoring(RBM)
Monitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification.
Clinical Trials & Evidence · adjacent
Clinical & Trials
Adaptive Trial Design
Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Clinical Trials & Evidence
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Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
NIH·1ICH·1ISO·1
- 1ClinicalTrials.govVerifiedNIHclinicaltrials.gov
- 2ICH GuidelinesVerifiedICHich.org
- 3ISO 14155 Standard PageVerifiedISOiso.org
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