EMA pilot to fast-track breakthrough medical devices
The European Medicines Agency has launched a new pilot programme aimed at accelerating the development of “breakthrough” medical devices
The European Medicines Agency (EMA) has launched a pilot to test a dedicated regulatory pathway for highly innovative devices where medicines and devices intersect. Manufacturers whose products receive a “breakthrough” designation will gain early and prioritised access to scientific advice from medical device expert panels.
The first phase will focus on higher-risk devices that administer or remove medicines from the body, an area where the intersection between medicines and devices is particularly clear. Future phases are expected to expand to additional device categories, including in vitro diagnostics.
Reform of medical devices rules
The pilot is linked to a broader overhaul of existing rules proposed in December by Health Commissioner Olivér Várhelyi, where he underlined the link between the latest therapies and their delivery: “The reality is that it is the medical devices sector that will become indispensable in this whole new era of medical technology, because it is going to be the medical devices that will translate the new therapies to the patients.”
The initiative also builds on guidance published in December 2025 by the Medical Device Coordination Group (see file below), which outlined key principles for identifying and supporting breakthrough devices.
Catherine Feore
Shifting roles in a changing landscape
Medical devices in the EU are normally regulated at the member state level, with conformity assessments conducted by notified bodies. The increasing convergence of medicines and devices, such as drug-device combinations, smart delivery systems, and digitally enabled therapies, is reshaping the regulatory landscape. As these hybrid technologies become more common, EMA’s role is expanding.