EMA is running a pilot programme offering expert panel support to manufacturers of breakthrough medical devices (BtX) and to notified bodies.
The pilot provides free advice as follows:
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.
EMA launched this pilot on 28 April 2026.
It is set to run in three phases until 2027, subject to available resources.
For information about EMA's work on medical devices, see:
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:
EMA accepts applications for inclusion in the first phase (Ia) of the pilot until 22 May 2026 (included).
Eligible devices in phase Ia include:
EMA prioritises the following types of devices in phase Ia:
Manufacturers should submit only one application in this first phase (Ia).
After the mentioned deadline, EMA selects five applications in phase Ia.
The medical device expert panels, with support from relevant national competent authorities, assess these applications and take the following actions:
The advice provided depends on the device’s stage of development. It may include an opinion on the following aspects:
The MDCG guidance also allows notified bodies to submit specific questions to the expert panels. These questions can address the clinical data required for the manufacturer’s clinical evaluation of a designated breakthrough device as part of the conformity assessment.
In the first phase of the pilot, the notified body that the manufacturer has selected is involved in the request for advice for one of the five selected applications. That one application needs to be the most advanced in its device development from all five applications. This means it needs to be in conformity assessment or near that stage.
Submit your letter of interest via the dedicated portal linked below:
Select “Advice in scope of MDCG guidance 2025-9” as the type of application.
To access the application you need to log in with your EMA account. If you do not have one, please visit the EMA Account Management website and follow the steps under 'Create an EMA account'.
Select the expandable panels below to learn about the phases of the breakthrough medical device pilot programme. This information is subject to change.
In the first phase, also referred to as phase Ia, applicants must meet the 22 May 2026 (included) application deadline.
The first phase is expected to continue with phase Ib, as of Q3 2026.
In phase Ib, manufacturers of high-risk medical devices can submit their requests for designation. High-risk medical devices refer to class III and class IIb active devices intended to administer or remove a medicinal product.
All applications within the scope of this pilot are accepted in phase Ib. Manufacturers who were not selected for phase Ia can re-submit in phase Ib.
In parallel, the applicants selected in phase Ia can submit their requests for advice.
For more information, see:
Phase II is expected to start in Q1 2027.
In this phase, EMA extends designation and advice requests to all classes of medical devices.
For more information, see:
Phase III is expected to start in Q3 2027.
In this phase, EMA extends designation and advice requests to in vitro diagnostics (IDVs).
Application templates are available in Word format to help manufacturers prepare for the pilot procedure by downloading and filling them in.
Manufacturers must only submit these templates to EMA after an application has been confirmed as:
These applications do not need to be attached at the letter of interest stage.
An information session prepared the launch of the breakthrough medical devices pilot programme.
For more information, including the event video recording (when available), see:
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.
28 April 2026
23 April 2026
2 March 2026
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