At the end of 2025, the EU Medical Device Coordination Group (MDCG) published guidance introducing the Breakthrough Devices framework (MDCG 2025-9 Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746 ). In the second quarter of 2026, the EMA will launch a pilot program to support breakthrough medical devices and in vitro diagnostics to test a pathway that accelerates patient access to highly innovative technologies.
Ahead of the launch of the pilot, an online information session has been scheduled for 24 April 2026. This information session will present the main elements of the Breakthrough Devices framework and highlight practical considerations for stakeholders preparing to engage with the process. A detailed agenda will be published in due course.
What is the EU Breakthrough Devices framework?
The framework aims to support earlier access for patients to innovative medical devices, including in vitro diagnostics (IVDs) with a significant positive clinical impact. This initiative is of relevance to manufacturers and developers involved in the development of innovative technologies and provides a structured pathway for designation and scientific input at different steps of the development cycle of a device.
A medical device or IVD may be considered a breakthrough technology if it meets both of the following criteria:
- Novelty: it is expected to introduce in the EU a high degree of novelty with respect to the device technology, related clinical procedure, or the application of the device in clinical practice; and
- Positive clinical impact: it is expected to provide a significant positive clinical impact on patients or public health, for a life-threatening or irreversibly debilitating disease or condition, by either of the following:
(i) offering a significant positive clinical or health impact compared to available alternatives and the state of the art; or
(ii) fulfilling an unmet medical need where there is an absence or insufficiency of available alternative options for that purpose.
To obtain a breakthrough designation, manufacturers need to request an opinion from EMA’s expert panels.
As part of the support, manufacturers of designated devices can access enhanced regulatory support and obtain dedicated scientific advice from expert panels on their planned clinical development strategy and the appropriate pre-clinical or clinical data for the clinical evaluation of the concerned medical devices. For IVDs, advice can be obtained on performance evaluation strategies and appropriate analytical or clinical performance data for the performance evaluation.
EMA will publish further procedural guidance and templates before the pilot’s launch on the EMA’s corporate website.
For more information on the EMA BtX or if you are considering entering the BtX pilot program and would like support, get in touch.