The European Medicines Agency (EMA) pilot programme to support breakthrough medical devices is scheduled to run in three phases through 2027, subject to available resources, according to the EMA. The agency announced that a second subphase would open on September 1, 2026, for Class III medical devices and certain active Class IIb medical devices.
What breakthrough designation means
According to the EMA, breakthrough medical devices are highly innovative devices that can address unmet medical needs or offer significant advantages over existing technologies. Manufacturers seeking this designation submit an application to the medical device expert panels, which issue an opinion on breakthrough status with support from national authorities. The process is based on guidance published by the Medical Device Coordination Group (MDCG) in December 2025. The MDCG guidance is intended to provide a streamlined path to CE marking without lowering clinical evidence requirements. Designation can take place months to years before expected market access, and a complete clinical dataset is not required at that point. However, the status does not confer market exclusivity: several products with the same intended purpose can be designated as breakthrough devices at the same time.
A digital twin against pancreatic cancer
The hopes associated with the status are illustrated by the CancerScan Digital Twin System, which received breakthrough designation under the EMA pilot, according to a statement from the CancerScan project dated June 8, 2026. According to the project, the system is intended to address the lack of a validated, individualised tool for selecting treatment for patients with pancreatic ductal adenocarcinoma. It combines patient-specific characterisation of the tumour microenvironment with a digital twin simulation to predict, before treatment begins, how an individual tumour might respond to potential chemotherapy treatments. According to the CancerScan project's announcement of June 8, 2026, structured discussions with the expert panel were scheduled to begin in September 2026 and clarify, among other things, study design, patient numbers and evidence requirements for CE marking.
A comparison: an earlier pilot and the United States
The EMA already has experience with such procedures: an earlier pilot providing advice to manufacturers of certain high-risk medical devices ran from February 2023 to February 2026, according to the EMA's final report, and concluded with the finalisation of all applications received. The pilot received 51 expressions of interest, and advice was provided in 27 completed procedures. The advice process took an average of 91.5 days. Excluding the seven particularly lengthy procedures, the average fell to 69 days. Internationally, a similar procedure exists in the form of the US Food and Drug Administration's (FDA) Breakthrough Devices Program, which the US Congress established in 2016 to promote innovation and facilitate patient access. A cross-sectional study published in the journal JAMA Internal Medicine in 2025 examined all therapeutic medical devices with breakthrough designation that received FDA marketing authorisation between 2016 and September 2024. The FDA designated 1,041 medical devices as breakthrough devices during this period, of which 127 received marketing authorisation. This represents 12.2 percent. The mean FDA review time was 225.8 days for all products examined. For high-risk products, the mean was 243.3 days.
What critics say
Within the EU, the existing system of expert panels is not without controversy: in a position paper dated November 8, 2026, Team-NB assessed the separate consultation mechanism under Article 54 of the Medical Devices Regulation as partially successful. The association warns that the procedure could cause a substantial administrative burden, uncertainty over evidence requirements and longer certification times. It calls for a clear process through which notified bodies can publish their reasoning when they issue certification despite an unfavourable expert opinion. The sources reviewed contain no response to this criticism from the expert panels or the European Commission. Elena Arbelo, a member of the ESC Regulatory Affairs Committee, cautioned that simplification must not jeopardise patient safety, as some risks only become apparent after years of use. The US study on the FDA programme also raises questions: of the 75 products examined, nine were recalled. One of the recalls was in the highest severity category. The study authors expressed uncertainty over whether the programme consistently achieves its goal of improving public health.
The EMA's timetable provides for further expansion of the pilot: Phase II is scheduled to begin in the first quarter of 2027 and extend designation to all medical device risk classes. Phase III is scheduled to follow in the third quarter of 2027 and also include in vitro diagnostic devices. Through the end of 2026, the EMA is establishing weekly submission windows to manage the expert panels' capacity. However, the entire duration of the pilot programme remains subject to available resources.