EMA Launches Pilot Program for “Breakthrough Devices” – Application Phase Now Open

Date

May 4, 2026

Category

EU Regulations

Description

On 28 April 2026, the European Medicines Agency (EMA) officially launched the long-awaited pilot program to support manufacturers seeking a "breakthrough device" (BtX) designation. For the first time, this program offers manufacturers of highly innovative technologies the opportunity to receive free scientific advice from expert panels to accelerate market access in the EU.

The aim is to foster patient access to technologies that offer a significant clinical advantage over existing standards or address unmet medical needs.

In the first of three phases, the pilot specifically targets manufacturers of:

• Class III medical devices.
• Class IIb active medical devices intended to administer or remove medicinal products from the body.

The application process

Interested companies can now submit requests for an opinion to the EMA. Application templates have been published on the EMA website for this purpose. After the application period, which ends on May 22, five applications will be selected in phase 1.

In accordance with the MDCG 2025-9, manufacturers must demonstrate both a high degree of innovation (novelty) and a significant positive clinical impact on patients or public health. Consequently, manufacturers should already provide initial meaningful data (e.g., preclinical data or pilot study results) to justify the status “breakthrough”.

Selected projects will benefit from scientific advice on their clinical development strategy and the data required for clinical evaluation. The pilot is scheduled to run until the end of 2027 and will be extended to include in vitro diagnostic medical devices (IVDs) in later phases.