MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746

MDCG Guidance MDCG 2025-12
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Summary

MDCG 2025-9 — Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 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 IDMDCG 2025-9
TypeMDCG Guidance
AuthorityMDCG
Publication Date2025-12

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Quick Info

TypeMDCG Guidance
Published ByMDCG
Date2025-12

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