The guidance sets out the criteria for BtX designation, requiring devices to demonstrate both a high degree of novelty relating to the technology, the associated clinical procedure, or the application of the device in clinical practice, and a reasonably expected significant positive clinical impact on patient or public health. The targeted conditions must be life-threatening, meaning likely to result in death without major medical intervention, or irreversibly debilitating, involving substantial and permanent impairment of daily functioning or quality of life.
MDCG 2025-9 outlines expectations for evidence generation throughout the device lifecycle, including non-clinical and pre-clinical data, as well as pre-market clinical evidence. It explicitly addresses the use of Post-Market Surveillance (PMS) and PMCF/PMPF, noting that, for BtX devices addressing unmet medical needs, placement on the market may be acceptable with more limited pre-market clinical evidence and a higher level of uncertainty, provided that a clear and well-defined plan is in place to collect confirmatory data post-market.
The document further describes the role of Expert Panels, which may provide opinions on BtX designation and offer early scientific advice on clinical development strategies, particularly for high-risk devices. The guidance notes that Expert Panels will endeavour to provide their opinions or advice within 60 days of a request, prioritising devices that have already received a positive BtX status opinion. Applications submitted for BtX status are expected to be prioritised by the Expert Panels.
Finally, the guidance describes procedural supports to facilitate timely market access. Notified Bodies are encouraged to prioritise BtX files during planning, engage in early and structured dialogue with manufacturers, and, where appropriate, issue certificates with specific conditions or provisions, often linked to the completion of PMCF/PMPF activities. MDCG 2025-9 also provides a high-level overview of national and European funding mechanisms supporting innovation, including programmes such as EU4Health and the European Innovation Council (EIC) Accelerator. A pilot to roll out the guidance is expected to be launched in Q2 2026, allowing stakeholders to gain practical experience with the BtX designation process.
What does this mean for you?
For manufacturers of medical devices and IVDs, MDCG 2025-9 introduces a structured pathway for Breakthrough Devices, highlighting opportunities for accelerated conformity assessment and early access to the market for highly innovative products addressing serious or unmet medical needs. Devices that qualify may benefit from prioritised dialogue with Notified Bodies and Expert Panels, potential flexibility on pre-market evidence requirements, and a clear framework for post-market data collection through PMS and PMCF/PMPF. The guidance also signals upcoming procedural pilots and support mechanisms, helping manufacturers plan ahead for regulatory interactions and early certification.
About the Author
MSc Biomedical Sciences · Director Authorised Representative Services & Manager IVD – Regulatory Affairs
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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