CATEGORY: DOCUMENTATION

General Safety and Performance Requirements (GSPR)

The fundamental requirements that medical devices must meet under EU MDR Annex I. GSPR replaced the Essential Requirements of the MDD and cover chemical/physical/biological properties, infection control, radiation, electronic devices, software, and labeling.

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

Map each applicable GSPR to evidence in technical documentation.
Link risk controls and clinical evaluation to GSPR claims.
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

EU MDR Annex I ↗

Track regulatory signals related to General Safety and Performance Requirements (GSPR) across 27 authorities in real time.

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