Only one Member State was assessing each valve when Brussels chose them, so the joint report will frame the evidence.

The European Commission has selected the first medical devices for joint clinical assessment under the EU Health Technology Assessment Regulation, in an implementing decision adopted on 2 October. Both are transcatheter mitral valve replacement systems: Edwards Lifesciences’ SAPIEN M3 and HighLife’s trans-septal system, each intended for patients with moderate-to-severe or severe mitral regurgitation whom a heart team judges unsuitable for surgery or edge-to-edge repair. The Dutch National Health Care Institute leads the SAPIEN M3 assessment with Norway’s Medical Products Agency, and France’s HAS leads HighLife’s with Poland’s AOTMiT. The Commission expects to select devices every quarter.

Devices in the first selection, both mitral valve replacements

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Selection criteria both devices met; the AI software criterion did not apply

Joint assessments of medicines under way, with four reports published

Member State with a national assessment under way for each device at selection

Access read

For most Member States, these joint reports will be the first assessment of either valve. The joint report will frame the evidence before most payers have formed a view of their own. Both valves already hold EU certificates, SAPIEN M3 since April 2025 and HighLife since January 2026, so the assessment weighs evidence the companies have already generated.

Structural heart companies: the comparator follows the label. Both intended purposes cover patients unsuitable for surgery or edge-to-edge repair, which points the comparison toward medical therapy. Makers of edge-to-edge repair devices sit outside this assessment, but the scoping will show how European assessors define standard care for the patients their devices cannot treat.
High-risk device sponsors: an expert panel opinion puts a device in the selection pool. The Commission chose from devices that went through the clinical evaluation consultation procedure, using information the EMA passes on each quarter. With quarterly selections, any device heading for an expert panel opinion should prepare a joint assessment dossier alongside certification.
Signposts: the scoping, the cadence and France. Watch the population and comparator scoping for each valve, the next quarterly selection, and how HAS carries its EU-level work on HighLife into France’s national reimbursement decision.

Read the original source (European Commission decision) →
Read the Commission announcement (DG Health and Food Safety) →

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Brussels Chose Two Transcatheter Mitral Valves for Its First Joint Device Assessments, With Only One Country Already Assessing Each