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2020-11-13 · Medical Devices Medical Device Coordination Group Document MDCG 2020-16 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 Page 1 of 44 1. Foreword This guidance relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro
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