Regulatory guidance
Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026
Published Dec 1, 2025
Reference
MDCG 2025-9
Source
MDCG
Topic
New technologies
Published
Dec 1, 2025
Languages
EN
© European Union — European Commission, DG SANTE. Reuse under CC BY 4.0.
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