MDCG 2021-28: Substantial modification of clinical investigation under MDR

MDCG Guidance MDCG 2021-12
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Summary

MDCG 2021-28 — Substantial modification of clinical investigation under MDR

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 2021-28
TypeMDCG Guidance
AuthorityMDCG
Publication Date2021-12

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Quick Info

TypeMDCG Guidance
Published ByMDCG
Date2021-12

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