Breakthrough medical devices: information session

• Date:
  Friday, 24 April 2026 , 15:00 - 17:00 Amsterdam time (CEST)
• Location:
  Online
  European Medicines Agency, Amsterdam, the Netherlands

Event summary

In December 2025, the Medical Device Coordination Group (MDCG) published a guidance introducing the Breakthrough Devices framework. This initiative is intended to support earlier access for patients to innovative medical devices including in vitro diagnostics (IVDs) with a significant positive clinical impact, while ensuring continued compliance with safety and performance requirements under the EU regulatory framework.

The Breakthrough Devices framework is of direct relevance to manufacturers, notified bodies and other stakeholders involved in the development and assessment of innovative technologies. It provides a structured pathway for designation and scientific input at different steps of the development cycle of a device at Union level.

In particular, the framework enables manufacturers of designated devices to obtain dedicated scientific advice from the expert panels intended to support evidence generation and clinical development.

Manufacturers seeking designation of a device as breakthrough are required to submit a request for an opinion to the 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.

Ahead of the launch of the pilot in Q2 2026, an online information session has been scheduled for 24 April 2026 in close collaboration with the European Commission.

This information session will present the main elements of the Breakthrough Devices framework and highlight practical considerations for stakeholders preparing to engage with the process. A detailed agenda will be published in due course.

Further procedural guidance and templates will be published ahead of the launch of the pilot.

This webinar is primarily intended for:

• medical device and IVD manufacturers;
• notified bodies.

Registration

• Registration is open until the start of the event

Registered participants receive the MS Teams webinar connection details for the session to their registered email address after successful registration.

Questions can be sent ahead of the information session via Slido. Passcode: bkhsgj