The European Commission adopted on October 5, 2026 its first decision selecting two medical devices for Joint Clinical Assessment (JCA) under the EU Health Technology Assessment Regulation, opening the device wave of Regulation (EU) 2021/2282 that has run only on medicines since it applied on January 12, 2025. Both selected devices address cardiovascular disease: the SAPIEN M3 Transcatheter Mitral Valve Replacement System from Edwards Lifesciences LLC and the Highlife Trans-septal Mitral Valve Replacement System from Highlife SAS.
No compliance date is set yet. Edwards Lifesciences and Highlife must submit clinical evidence under the PICO framework to their designated assessor and co-assessor national bodies, the Dutch National Health Care Institute (ZIN) with the Norwegian Medical Products Agency (DMP) for SAPIEN M3 and the French National Authority for Health (HAS) with the Polish Agency for Health Technology Assessment and Tariff System (AOTMiT) for Highlife, while other Class IIb/III implantable cardiovascular device manufacturers must prepare JCA readiness dossiers ahead of the quarterly selection rounds the Commission has announced. Without a JCA report, manufacturers face repeated national clinical assessments and potential delays or refusals in Member State reimbursement decisions, as the joint report feeds national pricing and reimbursement procedures.
What did the Commission decide?
The Commission adopted its first implementing decision on the selection of medical devices for joint clinical assessment, following the Member State Coordination Group on Health Technology Assessment recommendation at its June 22, 2026 meeting. It picks two cardiovascular mitral valve replacement systems as the first devices to enter the EU-level clinical assessment layer.
| Device | Manufacturer | Assessor | Co-assessor |
|---|---|---|---|
| SAPIEN M3 Transcatheter Mitral Valve Replacement System | Edwards Lifesciences LLC | Dutch National Health Care Institute (ZIN) | Norwegian Medical Products Agency (DMP) |
| Highlife Trans-septal Mitral Valve Replacement System | Highlife SAS | French National Authority for Health (HAS) | Agency for Health Technology Assessment and Tariff System, Poland (AOTMiT) |
The decision opens the device track of the HTA Regulation, under which fifteen JCAs are ongoing for medicinal products and four JCA reports have been published. The Commission expects device selection to occur on a quarterly basis going forward.
Which manufacturers are exposed?
Edwards Lifesciences and Highlife are the immediate addressees. Beyond them, EU manufacturers of Class IIb/III implantable cardiovascular devices face the quarterly selection rounds, and medtech regulatory affairs and clinical evidence teams must ready dossiers under the PICO (population, intervention, comparator, outcome) framework. The Implementing Regulation (EU) 2025/2086 sets the procedural frame for device JCA, building on the HTA Regulation that has applied to medicines since January 12, 2025.
What must manufacturers do, and by when?
No fixed compliance date is set yet. The two selected manufacturers must submit clinical evidence under the PICO framework to their assessor and co-assessor bodies, which produce a joint clinical assessment report and a summary report after consulting patients and clinical experts. Other Class IIb/III implantable device makers should track the quarterly selection rounds and prepare PICO dossiers before their products are picked, so the clinical evidence is ready when a selection lands.
What happens without a JCA report?
The joint clinical assessment report feeds Member States' national pricing and reimbursement procedures. Without it, manufacturers face repeated parallel national clinical assessments and potential delays or refusals in reimbursement decisions. Pricing and reimbursement stay national; the JCA covers clinical value only.
Verify whether your portfolio includes Class IIb/III implantable cardiovascular devices in scope of the quarterly JCA rounds, brief your clinical evidence and regulatory affairs teams on the PICO framework, and track the next selection step through the Commission's JCA tracker for medical devices. Obsidian's per-jurisdiction monitoring surfaces the next selection the moment the Commission publishes it.
