On 28 April 2026, the European Medicines Agency (EMA) launched a pilot pathway designed to support the development of breakthrough medical devices in the European Union (EU).
The agency’s intent is for the new pathway to support patient access to ‘highly innovative’ medical technologies.
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As part of the initiative, manufacturers whose devices are granted ‘breakthrough’ status will benefit from enhanced regulatory support, including priority scientific advice from the medical device expert panels that are overseen by EMA.
While not a direct mirror image of similar regulatory regimes in the US, such as the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health’s (CDRH) Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, the EMA’s initiative appears to have similar outcomes in mind.
However, at this time, the voluntary pilot remains open-ended and, at its inception, is focused on Class III medical devices, with theoretical expansion to inaugurate further device risk level classifications in future.
In this episode, Medical Device Network spoke with Stephen Gilbert, Professor of Medical Device Regulatory Science, Technische Universität, Dresden, to weigh the benefits of the EMA’s pilot and reflect on how it may evolve in future, among many other related topics.
Listen to the full episode below:
