Helsinki Procedure: Helsinki Procedure for borderline and classification under MDR & IVDR

MDCG Guidance MDCG 2021-09
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Summary

Helsinki Procedure — Helsinki Procedure for borderline and classification under MDR & 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 IDHelsinki Procedure
TypeMDCG Guidance
AuthorityMDCG
Publication Date2021-09

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TypeMDCG Guidance
Published ByMDCG
Date2021-09

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