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CATÉGORIE: DOCUMENTATION

Exigences générales de sécurité et de performance (GSPR)

Les exigences fondamentales que les dispositifs médicaux doivent satisfaire selon l'Annexe I de l'EU MDR, remplaçant les Exigences essentielles de la MDD.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our editorial policy.

WHEN IT APPLIES

General Safety and Performance Requirements (EU MDR Annex I) replaced MDD Essential Requirements and define what devices must meet for CE conformity.

PROCESS / STEPS

  1. Map each applicable GSPR to evidence in technical documentation.
  2. Link risk controls and clinical evaluation to GSPR claims.
  3. Update GSPR checklist after design/labeling changes.

EXAMPLES

  • Software devices emphasize GSPR sections on IT security and information supplied by the manufacturer.

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

EU MDR (Règlement 2017/745)Documentation technique