MDCG 2023-1: Guidance on the health institution exemption under Article 5(5) of MDR and IVDR

MDCG Guidance MDCG 2023-01
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MDCG 2023-1 — Guidance on the health institution exemption under Article 5(5) of MDR and IVDR

This is a guidance document endorsed by the Medical Device Coordination Group (MDCG) under the EU Medical Device Regulation (MDR 2017/745) and/or In Vitro Diagnostic Regulation (IVDR 2017/746).

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Document Details

Document IDMDCG 2023-1
TypeMDCG Guidance
AuthorityMDCG
Publication Date2023-01

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TypeMDCG Guidance
Published ByMDCG
Date2023-01

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