(EU) In-vitro diagnostic medical devices Regulation 2017/746

Discover our guides and templates for the general compliance of (EU) IVDR 2017/746

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General Safety & Performance Requirements (GSPR) Template (IVDR)

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Access a complete framework/template for documenting your GSPRs in accordance with Annex I of IVDR 2017/746. For each GSPR: access a list of standards, a list of expected documents and a pre-written methodology. Use this template as a guide from the start of your project. 45 pages, available for immediate download