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    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. The CER follows a clinical evaluation plan and draws on clinical investigations, literature and post-market data, including PMCF. MEDDEV 2.7/1 rev 4 is still widely used for structure, with MDCG guidance covering equivalence and sufficient clinical evidence. Notified bodies review the CER during conformity assessment, and it must be updated with PMS and PMCF findings, at least annually for Class III and implantable devices.
    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.

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    Sources

    3 sources

    Every citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.

    Tier 1Binding law and standards· 1Tier 2Regulator guidance and consensus· 1Tier 3Peer-reviewed and registry evidence· 1
    Link health: 3 verified· last checked 2026-06-20
    NIH·1ICH·1ISO·1
    1. 1
      ClinicalTrials.gov
      Tier 3 Verified
      NIHclinicaltrials.gov
    2. 2
      ICH Guidelines
      Tier 2 Verified
      ICHich.org
    3. 3
      ISO 14155 Standard Page
      Tier 1 Verified
      ISOiso.org

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