General Safety and Performance Requirements (Annex I) in ...

SPR 22: Protection against the risks posed by medical devices intended by the manufacturer for use by lay persons 14 SPR 23: Label and instructions for use 14 SPR 23.1: General requirements for information supplied by the manufacturer 15 SPR 23.2: Label requirements 16 SPR 23.3: Sterile package label requirements 17

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