MDR/IVDR Watch / Archive
MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under MDR 2017/745 and IVDR 2017/746 (December 2025)
Published 15 Dec 2025
MDCG published guidance on the breakthrough device (BtX) designation under the MDR and IVDR, covering breakthrough criteria, pre-clinical and clinical evidence expectations, PMCF/PMPF, expert panel and early-advice procedures, notified body responsibilities and support for SMEs. The document is non-binding and manufacturers seeking breakthrough status should review the criteria and evidence expectations.
Original title: MDCG 2025-9: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
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New MDCG guidance, implementing acts, standards and EUDAMED changes, each explained in two lines: what changed and who must act.
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