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MDCG 2022-2 Guidance on general principles of clinical ...

MDCG 2022-2 Guidance on general principles of clinical ...

ec.europa.eu

Medical Devices Medical Device Coordination Group Document MDCG 2022-2 Page 3 of 31 1. Purpose This document outlines the general principles of clinical evidence and provides guidance on the continuous process of performance evaluation for in vitro diagnostic medical devices (hereafter referred to as IVDs), as set out in Regulation (EU)

  Devices, Principles, Medical, Medical device, Medical devices medical

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