Manual on Borderline v4: Manual on borderline and classification under Regulations 2017/745 and 2017/746

MDCG Guidance MDCG 2025-09
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Summary

Manual on Borderline v4 — Manual on borderline and classification under Regulations 2017/745 and 2017/746

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 IDManual on Borderline v4
TypeMDCG Guidance
AuthorityMDCG
Publication Date2025-09

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TypeMDCG Guidance
Published ByMDCG
Date2025-09

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