Pilot programme to be launched to support breakthrough medical devices and in vitro diagnostics

‍In the second quarter of 2026, the European Medicines Agency (EMA) will launch a pilot programme to support breakthrough medical devices and in vitro diagnostic devices. The purpose of the programme will be to test a pathway that is intended to accelerate patient access to highly innovative technologies, while maintaining the EU’s high standards for safety and performance. Manufacturers participating in the pilot will benefit from enhanced regulatory support and priority scientific advice from the EMA medical device expert panels.

On 24 April 2024, an online information session will be held. The session will present the main elements of the programme and practical considerations for those seeking to engage with the process.

The Pilot Programme is a follow-on from the recent adopted Guidance on Breakthrough Devices MDCG 2025-9. The Guidance provides direction concerning the steps to be taken by manufacturers to demonstrate that their medical device or IVD fulfils the criteria permitting them to be considered Breakthrough Devices (including an overview of related criteria) and to ensure that clinical, non-clinical, and post-market surveillance (PMS) and PMCF/PMPF obligations are fulfilled.

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