European Commission selects first medical devices for joint clinical assessment
The European Commission has selected two cardiovascular devices for the first medical device joint clinical assessments under the EU HTA Regulation
The European Commission has announced the selection of the first two medical devices for joint clinical assessment (JCA) under the EU Health Technology Assessment (HTA) Regulation, marking the start of joint EU-level clinical assessments for medical devices.
Both devices are designed to treat cardiovascular conditions and focus on mitral valve replacement.
The first, the SAPIEN M3 Transcatheter Mitral Valve Replacement System, manufactured by Edwards Lifesciences LLC, will be assessed by the Dutch National Health Care Institute (ZIN), alongside Norway’s Medical Products Agency (DMP) as co-assessor.
The second, the Highlife Trans-septal Mitral Valve Replacement System, developed by Highlife SAS, will be assessed by France’s National Authority for Health (HAS), supported by Poland’s Agency for Health Technology Assessment and Tariff System (AOTMiT).
The Commission’s decision follows a recommendation issued by the Member State Coordination Group on Health Technology Assessment at its 22 June meeting.
The selection marks an expansion of JCA activities, which have so far focused on medicinal products. Currently, 15 assessments of medicines are ongoing, while four JCA reports have been published.
Under the HTA Regulation, joint assessments examine the comparative clinical benefits of health technologies, with input from patients and clinical experts. The resulting reports inform national HTA processes and decision-making across EU member states.
The Commission expects further medical devices to be selected for joint clinical assessment on a quarterly basis.