Translated with AI
On December 16, 2025, the European Commission published the new guidance MDCG 2025-9 on “Breakthrough Devices (BtX)”. The objective is to promote and facilitate the market entry of highly innovative Medical Devices and in vitro diagnostic Medical Devices intended for the treatment of serious diseases or health conditions, without compromising safety and clinical evidence.
This initiative represents a major step toward extending advanced medical technology to those in need by streamlining complex bureaucratic procedures that risk making such products marginal or inaccessible.
Practical implementation will begin with a Pilot Project scheduled for launch in Q2 2026 (April, May, June 2026).
What is a BtX? Selection Criteria
Not all innovative devices qualify as Breakthrough Devices. To fall under this guidance, a medical device or IVD must meet all the following requirements:
- Novelty: it must introduce a high degree of innovation in technology and clinical procedure, representing a technological or clinical leap compared to the “State of the Art” (e.g., new mechanisms of action, revolutionary materials, or advanced AI algorithms).
- Significant Clinical Impact: the device is expected to offer a positive clinical impact on patients or public health by:
– Significantly outperforming the performance of current therapies and the State of the Art;
OR
– Addressing an unmet medical need that has remained unanswered due to the lack or ineffectiveness of existing therapeutic options. - Critical Target: it must be intended for life-threatening or irreversibly debilitating conditions.
Data Rebalancing
The core of MDCG 2025-9 lies in the concept of “Data Rebalancing”. This approach recognizes that, for radically new technologies, collecting comprehensive pre-market clinical evidence may be ethically or technically challenging.
Key Principle: The guidance allows for the certification of a device by accepting “residual clinical uncertainty” at the time of CE marking, provided it is compensated by extremely rigorous post-market surveillance.
Companies must be prepared to manage:
- Structured PMCF/PMPF Plans: continuous and active clinical monitoring to confirm initial benefits.
- Real-World Evidence (RWE): utilizing data from daily clinical practice and national registries to corroborate device performance.
Procedural Pathway and Scientific Support
BtX innovation is not a bureaucratic shortcut, but a pathway characterized by intense scientific dialogue. The guidance includes:
- Expert Panel Involvement: for high-risk devices, support from EU experts is essential to validate the “Breakthrough” nature of the product during conformity assessment.
- Early Dialogue with Notified Bodies: encouraging timely consultation on clinical strategy to avoid bottlenecks in the final certification stages.
- Pilot Project (Q2 2026): a trial phase to refine evaluation criteria before full implementation.
The BtX document paves the way for a path of excellence, supporting responsible innovation and accelerating patient access to life-saving technologies while ensuring a high level of public health protection.
For full details, please refer to the guidance document
>>> Thema supports innovation and guides your Medical Devices into the EU market in full regulatory compliance. Contact us for strategic regulatory consultancy.
SOURCES:
MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746
