New pilot to support development of ‘breakthrough’ medical devices
Enhanced regulatory support and priority access to scientific advice for developers
NewsHumanMedical devices
EMA has launched a pilot programme to support the development of breakthrough medical devices in the European Union (EU). The purpose of the pilot is to test a new regulatory pathway that supports patient access to highly innovative technologies, while maintaining the EU’s rigorous safety and performance standards.
As part of the pilot, manufacturers whose devices are granted ‘breakthrough’ status will benefit from enhanced regulatory support, including priority scientific advice from the medical device expert panels that are overseen by EMA.
Breakthrough designation can be granted to highly innovative medical devices that demonstrate the potential to address unmet medical needs, or that offer substantial advantages over existing technologies. As part of the pilot, manufacturers seeking breakthrough designation can submit a request for an opinion to the medical device expert panels.
The assessment will consider, among other aspects, the degree of innovation and the potential to address unmet medical needs or provide significant clinical benefit compared with existing alternatives.
The EMA pilot will be conducted in three phases. Phase one is open to class III (high risk) medical devices and class IIb active medical devices intended to administer or remove medicines from the body. Detailed guidance and application templates for manufacturers for phase one are published on EMA’s website. Subsequent phases of the pilot will be open to other types of devices, including in vitro diagnostics (IVDs).
The pilot builds on the recently adopted Guidance on Breakthrough Devices that was published by the European Commission’s Medical Device Coordination Group (MDCG) in December 2025.
EMA, in close collaboration with the European Commission, hosted a breakthrough medical devices information session on the pilot on Friday, 24 April 2026. The session presented the main elements of the Guidance on Breakthrough Devices and highlighted practical considerations for stakeholders preparing to take part in the pilot process.
The pilot marks an important step in strengthening Europe’s innovation-friendly regulatory environment for medical technologies, with the goal of ensuring patients can access safe and effective breakthrough innovations as quickly as possible.
It is a first step towards the formal implementation of a framework for breakthrough medical devices, which the European Commission included in its December 2025 proposal for revising the Medical Devices Regulation (MDR) and In Vitro Devices Regulation (IVDR) (new Article 52a of the MDR and new Article 48a of the IVDR).
This work also aligns with the objectives of the EU Biotech Act to foster an innovation friendly regulatory environment and accelerate the development and uptake of cutting-edge health technologies for patients in the EU.
EMA’s role in regulating medical devices
Medical devices are products or equipment intended for a medical purpose. They are regulated at EU Member State level through notified bodies, but EMA is involved in several regulatory processes.
Many medicines need a medical device to be used. With ongoing advances in technology, the number of new therapies that combine medicines and devices is increasing.
For certain high-risk devices, notified bodies need to consult expert panels before issuing a CE (Conformité Européenne) certificate. These expert panels benefit from EMA's technical and scientific support.
The pilot programme is one of the initiatives to extend the role of expert panels to support the development and assessment of breakthrough medical devices.