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GLOSSARYEU

MDR Annex I (GSPR)

The EU MDR's list of general safety and performance requirements for devices. It runs in three chapters: general requirements, requirements for design and manufacture, and requirements for the information supplied with the device.

Chapters

Chapter I
General requirements
Chapter II
Requirements regarding design and manufacture
Chapter III
Requirements regarding the information supplied with the device
Where it is written
Regulation (EU) 2017/745, Annex I (consolidated text of 10 January 2025)
Also called
Annex I, GSPR, General Safety and Performance Requirements

Related terms