EMA launches Breakthrough Medical Device Pilot

On Friday 24 April 2026, the European Medicines Agency (EMA) hosted a two-hour information session on its new Breakthrough Medical Device Pilot. Four days later, on April 28, the pilot opened.

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.