The European Medicines Agency (EMA) has launched a new pilot programme aimed at supporting the development of highly innovative medical devices with the potential to address unmet medical needs. “Breakthrough designation” may be granted to medical devices that demonstrate the potential to provide substantial advantages over existing technologies or to address conditions for which adequate treatment or diagnostic options are currently lacking. 

The initiative, launched on 28 April 2026, offers free scientific and regulatory support to manufacturers of breakthrough medical devices, defined as medical devices (MDs) or in vitro diagnostic medical devices (IVDs) that may provide substantial advantages over existing solutions or address conditions for which adequate treatment or diagnostic options are currently lacking. 

According to the guidance published by the Medical Device Coordination Group (MDCG) in December 2025, the designation of breakthrough medical devices aims to accelerate patient access to innovative devices while maintaining high standards of safety, clinical performance and regulatory oversight. 

Through the pilot, EMA’s medical device expert panels will provide: 

• advice to manufacturers seeking breakthrough designation for their devices; 

• scientific and regulatory guidance for manufacturers of already designated breakthrough devices. 

The type of support provided will depend on the stage of development of the device and may include advice on pre-clinical evidence generation, clinical development strategies, and post-market clinical follow-up activities. 

Notably, the MDCG guidance also allows notified bodies involved in the conformity assessment under the Medical Device Regulation (MDR) to request advice from EMA expert panels regarding the clinical data needed to support the manufacturer’s clinical evaluation. 

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, with priority reserved to cardiovascular devices and devices intended for children. 

During the first phase of the pilot, EMA will accept applications until 22 May 2026, and five applications are expected to be selected.  

Manufacturers interested in participating in the pilot program must submit their applications through the EMA procedure described in the dedicated guidance documents. 

Subsequent phases of the pilot, planned through 2027 and subject to available resources, will be expanded to include other categories of medical devices, including in vitro diagnostic medical devices (IVDs). 

The initiative represents a further step towards strengthening collaboration between regulators, notified bodies and developers of innovative technologies within the European regulatory framework for medical devices, with the aim of facilitating timely patient access to safe, effective and high-quality breakthrough innovations. This work also supports the objectives of the EU Biotech Act by promoting innovation and accelerating patient access to advanced health technologies in the EU. 

Read more here.