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    Summary of Safety and Clinical Performance

    Public-facing summary required for high-risk and implantable devices under EU MDR.

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

    Definition

    Per MDR Article 32, manufacturers must produce an SSCP for implantable and Class III devices. The validated document is published on EUDAMED so patients and healthcare professionals can access key clinical evidence.

    What this means in practice

    SSCPs are validated by the Notified Body and updated at least annually for implants and Class III. They must be written in plain language for the patient sections.

    Cross-references

    Part of

    A larger framework or document this term belongs to.

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    MDCG·1European Commission·1IMDRF·1
    1. 1
      MDCG 2019-9 SSCP Guidance
      Bot-blocked
      MDCGhealth.ec.europa.eu
    2. 2
      European Commission - Medical Devices
      Verified
      European Commissionhealth.ec.europa.eu
    3. 3
      IMDRF Documents
      Verified
      IMDRFimdrf.org

    Inline markers like [1] jump to the matching reference above.