MDCG guidance
MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026
MDCG guidance · New technologies · December 2025
Key facts
| Reference | MDCG 2025-9 |
|---|---|
| Title | Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026 |
| Topic | New technologies |
| Published | December 2025 |
| Document | health.ec.europa.eu |
At a glance
- Yes Full text searchable in Orca1
- MDCG 2025-9 (December 2025) Revisions on file
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About MDCG guidance documents
The Medical Device Coordination Group (MDCG), made up of EU member-state experts, endorses guidance on applying the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746. Each page here covers one document and all of its revisions.