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    General Safety and Performance Requirements

    Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets.

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

    Definition

    GSPRs replace the old Essential Requirements of MDD/IVDD. Manufacturers prepare a GSPR checklist mapping each requirement to the design output, harmonized standard, and documentary evidence demonstrating conformity.

    What this means in practice

    The GSPR checklist is the spine of the EU technical documentation and one of the first things a Notified Body audits.

    Primary references

    3 sources
    Link health: 3 verified· last checked 2026-05-09
    EUR-Lex·1IMDRF·1RAPS·1
    1. 1
      MDR Annex I
      Verified
      EUR-Lexeur-lex.europa.eu
    2. 2
      IMDRF Documents
      Verified
      IMDRFimdrf.org
    3. 3
      RAPS Regulatory Focus
      Verified
      RAPSraps.org

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