European Commission targets unmet cardiovascular need with first medical devices selected for JCA

Two mitral valve replacement systems become the first medical devices selected for joint clinical assessment under the EU HTA Regulation. The decision extends joint assessment work to devices, with unmet medical need and the potential value of a shared assessment among the reasons for selection.

The Baseline

• The European Commission has selected the SAPIEN M3 and Highlife mitral valve replacement systems for Joint Clinical Assessment.
• Both address patients with mitral regurgitation who are unsuitable for surgery or transcatheter edge-to-edge treatment.
• Further device selections are expected quarterly, with a new public tracker available to follow the assessments.

The European Commission has adopted its first decision selecting medical devices for Joint Clinical Assessment (JCA) under the EU Health Technology Assessment (HTA) Regulation. Finalized on October 2, 2026, the decision covers two mitral valve replacement systems and follows a recommendation from the Member State Coordination Group on HTA (HTACG) at its June 22 meeting.

The selected devices are the SAPIEN M3 Transcatheter Mitral Valve Replacement System, manufactured by Edwards Lifesciences LLC, and the Highlife Trans-septal Mitral Valve Replacement System, manufactured by Highlife SAS.

The SAPIEN M3 assessment will be led by an assessor from the Dutch National Health Care Institute (ZIN), with a co-assessor from the Norwegian Medical Products Agency (DMP). For Highlife, the assessor and co-assessor are from the French National Authority for Health (HAS) and Poland’s Agency for Health Technology Assessment and Tariff System (AOTMiT), respectively. All four agencies are already involved in JCAs of medicinal products, serving as assessors or co-assessors.

The implementing decision provides further detail on why the devices were selected. Both meet five selection criteria: unmet medical need, first-in-class status, potential impact on patients or healthcare systems, a significant cross-border dimension and added value at EU level.

SAPIEN M3 addresses symptomatic moderate-to-severe or severe mitral regurgitation in patients deemed unsuitable for surgery or transcatheter edge-to-edge therapy by a heart team. The Highlife TMVR system addresses moderate-to-severe or severe mitral regurgitation of primary, secondary or mixed origin in patients unsuitable for surgical repair or replacement, or transcatheter edge-to-edge repair, subject to additional cardiac function and anatomical criteria.

The Commission describes each device as first in class on the basis of its mechanism of action or technological approach for the relevant indication. It also identifies their potential to improve survival, morbidity and quality of life. These are reasons for selecting the devices for assessment; the decision does not establish their comparative clinical benefits.

The decision also acknowledges the potential challenge of avoiding duplication between EU and national assessments, as both devices were already CE-marked when the HTACG adopted its recommendation. Although one Member State had reported an ongoing national assessment for each device, several others confirmed that a joint assessment would add value, which the Coordination Group considered sufficient to mitigate the duplication risk.

The Commission links the selection to its wider cardiovascular health agenda, including the Safe Hearts Plan, stating that JCAs of cardiovascular devices are “expected to help Member States make fast and informed decisions on the pricing and reimbursement of those medical devices”.

Alongside the first selections, the Commission has launched a dedicated medical devices JCA tracker, providing a public resource for following joint assessment activity as it extends to devices. With further selections expected quarterly, the tracker will help stakeholders monitor which technologies enter the process.

The new resource complements the Commission’s medicinal-product JCA tracker. In its October 6 announcement, the Commission reports 15 ongoing medicinal-product assessments and four published JCA reports.