The Commission has adopted its first decision to select two medical devices for joint clinical assessment under the EU Health Technology Assessment (HTA) Regulation. The two devices are both addressing cardiovascular disease.
One of the selected devices is the SAPIEN M3 Transcatheter Mitral Valve Replacement System, manufactured by Edwards Lifesciences LLC. The assessor and co-assessor for this joint clinical assessment are from the Dutch National Health Care Institute (ZIN) and the Norwegian Medical Products Agency (DMP), respectively.
The other device is the Highlife Trans-septal Mitral Valve Replacement System, manufactured by Highlife SAS. The assessor and a co-assessor for this joint clinical assessment are from the French National Authority for Health (HAS) and the Agency for Health Technology Assessment and Tariff System, Poland (AOTMiT).
The Commission Decision follows the recommendation by the Member State Coordination Group on Health Technology Assessment at its 22 June meeting.
Currently, there are 15 Joint clinical assessments ongoing for medicinal products with 4 published JCA reports. Today marks the beginning of joint work on medical devices under the HTA regulation.
Joint Clinical Assessments allow EU Member States to work together to assess the clinical benefits of new medicines and certain medical devices compared to existing health technologies. Patients and clinical experts are systematically consulted during this process. The outcome is a joint clinical assessment report and summary report. These reports will be used by Member States in their national decision-making procedures.
The selection of medical devices for joint clinical assessments is expected to occur on a quarterly basis.
Excerpt from the official page. The original is authoritative.