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General Safety and Performance Requirements

Essential requirements for Invitro Diagnostic Medical Devices and Medical Devices to General Safety and Performance Requirements

The ‘essential requirements’ for IVD (IVDD 98/79/EC, annex I) and medical devices (MDD 93/42/EEC, annex I) will be replaced by the ‘general safety and performance requirements’ (GSPR) in the new Regulations. This means new requirements for you as a manufacturer. IWA Consulting has prepared GSPR templates including all requirement groups.

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Template MD

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Template IVD

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