Expert panel support for breakthrough medical devices: pilot programme

The European Medicines Agency (EMA)'s pilot programme on breakthrough medical devices (BtX) is designed to establish a long-term process for manufacturers to request support from the medical device expert panels.

EMA is set to launch a pilot programme for expert panel support to manufacturers of breakthrough medical devices (BtX) on 28 April 2026.

The pilot is designed to provide free advice to selected manufacturers of high-risk medical devices on:

• possible breakthrough medical device status - for medical devices seeking this type of designation;
• additional advice on how to implement the guidance that the Medical Device Coordination Group provided - for designated breakthrough medical devices.

Breakthrough medical devices are 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 submit a request for an opinion to the medical device expert panels.

The pilot is set to run in three phases until 2027, subject to available resources.

For information about EMA's work on medical devices, see:

• Medical devices

Guidance on designating breakthrough medical devices

Guidance is available to help determine whether a medical device can be designated as ‘breakthrough’.

The aim of designation is to accelerate access to highly innovative medical devices and in vitro diagnostics (IVDs) while maintaining rigorous safety and performance standards.

It also provides a benchmark to manufacturers and notified bodies on the clinical evaluation of breakthrough devices which require clinical data evidence to demonstrate conformity with the Medical Device Regulation (Regulation (EU) 2017/745). 

The Medical Device Coordination Group (MDCG) published guidance in December 2025.

For more information, see:

• Medical Device Coordination Group: Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746.

Pilot application templates

Application templates are available below, for information purposes only before the launch of the pilot.

Breakthrough status request: Template for applicants for breakthrough medical devices pilot

Advice request: Template for applicants for breakthrough medical devices pilot

Information session

An information session on 24 April 2026 supports the launch the breakthrough medical devices pilot programme.

For more information, including the related registration link, see:

• Breakthrough medical devices: information session (24/04/2026)

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2026.

See update history

24 April 2026

Sections on 'Pilot application templates', 'Guidance on designating breakthrough medical devices' and 'Information session on pilot for breakthrough medical devices' added. Page introduction also updated with information on pilot scope and launch date.

2 March 2026

Page first published; Content has been moved from another webpage as part of a broader content reorganisation