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    Common Specifications

    Mandatory technical specifications under EU MDR/IVDR where harmonized standards are insufficient.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    Common Specifications are sets of technical and clinical requirements adopted by the European Commission via implementing acts. Compliance creates a presumption of conformity with the corresponding MDR/IVDR requirements.

    What this means in practice

    CS exist for Annex XVI products (non-medical aesthetic devices) and certain Class D IVDs, among others. Where a CS exists, manufacturers must comply or justify equivalent solutions.

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    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    European Commission·1IMDRF·1RAPS·1
    1. 1
      MDR/IVDR Common Specifications
      Verified
      European Commissionhealth.ec.europa.eu
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

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