The European Medicines Agency (EMA) will launch a pilot programme to support breakthrough medical devices and diagnostics with a significant positive clinical impact. This initiative aims at speeding up patient access to innovative technologies.
Its launch is expected between April and June 2026. Through this programme, selected manufacturers designated breakthrough devices will receive enhanced regulatory support and priority scientific advice.
Key information and participation
On 24 April, EMA will hold an online information session. This webinar is mainly intended for medical device and IVD manufacturers as well as notified bodies and participation requires an online registration. The agenda can be found here.
The pilot is based on the recent MDCG Guidance on Breakthrough Devices MDCG 2025-9, published in December 2025.
What are breakthrough devices?
As explained in MDCG 2025-9, a medical device or IVD can be considered breakthrough “only if it is reasonably expected to provide a significant positive clinical impact to patient or public health for life-threatening or irreversibly debilitating diseases or conditions, in the context of current alternative options (if any) and state of the art.” The device’s expected clinical impact must be compared with existing alternatives in terms of performance, safety, risks, and patient quality of life. If there are no alternatives, the manufacturer must show how the device meets an unmet medical need.
Manufacturers seeking designation of a device as breakthrough need to submit a request for an opinion to the expert panels. Among others, the assessment considers the degree of innovation and the potential to address unmet medical needs. In addition, the assessment also analyses the device’s significant clinical benefit compared with existing alternatives.
Questions? Contact us here or at mdlaw@obelis.net.
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