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Articles Tagged: Common Specifications

IVDR COMMON SPECIFICATIONS

The European Commission has published Commission Regulation (EU) 2022/1107 which lays down Common Specifications (CS) for certain Class D In Vitro Diagnostic (IVD) medical devices in relation to the IVD Regulation 2017/746 (IVDR). Common Specifications are a set of technical and/or clinical requirements which provide a means of complying with the legal obligations for a ...

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