EMA announces launch of pilot for breakthrough medical devices |

In the second quarter of 2026, the EMA plans to launch a pilot for breakthrough #medicaldevices and #invitrodiagnostics with the goal to test a pathway that accelerates patient access to highly innovative technologies, while guarding #safety and #performance standards.

This pilot further builds on the recently adopted guidance MDCG 2025-9:

For all devices, clinical evidence must demonstrate compliance with the #MDR or #IVDR. However, a device with a high degree of novelty is often associated with uncertainty regarding its safety or performance, due to limited prior scientific knowledge or data from similar or equivalent devices. To still ensure timely patient access to devices with a potential positive clinical impact compared with the state of the art MDCG 2025-9 was developed, indicating that clinical evidence may be considered acceptable in case the available data sufficiently demonstrates:

• that the benefit-risk ratio is acceptable,
• that it is reasonably expected the device will provide a clinical benefit, taking into account the clinical condition, the state of the art, and the safety of patients,
• the manufacturer has an appropriate PMS, #PMCF/PMPF plan in place with a clear justification as to why the clinical data cannot be collected in the pre-market phase,
• users and patients will be adequately informed of the breakthrough status of the device and on how to report incidents, complaints, and other clinical experience to the manufacturer,
• appropriate measures are in place to meet any conditions or provisions of certification that have been imposed by a notified body.

​https://ec.europa.eu/newsroom/sante/newsletter-archives/74172