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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.

    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.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Precedes

    Comes before in a typical workflow or lifecycle.

    Primary references

    3 sources
    Link health: 2 verified 1 needs review· last checked 2026-05-09
    MDCG·1NIH·1ICH·1
    1. 1
      MDCG 2020-13 CER Template
      Needs review
      MDCGhealth.ec.europa.eu
    2. 2
      ClinicalTrials.gov
      Verified
      NIHclinicaltrials.gov
    3. 3
      ICH Guidelines
      Verified
      ICHich.org

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