EU Selects First Medical Devices for Joint Clinical Assessment

The European Commission has adopted the first decision selecting medical devices for joint clinical assessment at Union level under the Health Technology Assessment (HTA) Regulation. Commission Implementing Decision C(2026) 7113 was adopted on 2 October 2026 and announced in the Commission's 6 October health newsletter.

The decision selects two cardiovascular devices:

The Commission's newsletter names the assessor organizations: 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 Poland's AOTMiT for HIGHLIFE.

Why these two devices were selected

The HTA Coordination Group recommended both devices on 22 June 2026. The selection pool is not the whole device market: the Commission selects from devices for which the relevant EU Medical Device Regulation (MDR) expert panel has given a clinical evaluation consultation procedure (CECP) opinion, or for in vitro diagnostic medical devices (IVDs), views given under the In Vitro Diagnostic Medical Device Regulation (IVDR) Article 48(6) performance evaluation consultation procedure.

Under Article 7(4) of the HTA Regulation, selection uses six criteria: unmet medical needs, first-in-class status, potential impact on patients, public health or healthcare systems, incorporation of AI or machine learning, cross-border dimension, and Union-wide added value. A device needs at least one. The decision records that both devices meet the unmet-need, first-in-class, potential-impact, cross-border and Union-wide-value criteria. The AI/machine-learning criterion is not among those listed for either device.

Both devices had already been issued all conformity certificates when the Coordination Group recommended them. The decision addresses the resulting duplication risk directly: only one Member State had declared an ongoing national assessment for each device, while several Member States considered a Union-level assessment more valuable.

What happens next

The Commission's device JCA page distinguishes preparation after certification from the dossier request following selection:

1. Once a recommended device is certified, the JCA Subgroup appoints an assessor and co-assessor and selects patients, clinicians and other experts to consult.
2. It develops the assessment scope and finalizes it after the selecting decision: patient population, intervention, comparators and health outcomes.
3. The Commission sends the scope to the health technology developer and requests the dossier. The developer has 100 days to deliver it through the secure HTA IT Platform, using the template in Annex I or II of Implementing Regulation (EU) 2025/2086. This period follows the Commission's request, not the selection decision alone.
4. Within 15 working days, the Commission either confirms the dossier or sends a second request listing missing items; the developer then has 15 days to respond.
5. The assessors prepare a Joint Clinical Assessment Report and summary report. The developer gets a factual accuracy check before finalization.

The reports describe the scientific analysis of the clinical evidence. They do not contain a value judgement on the device's overall clinical added value, and they do not decide pricing or reimbursement. Member States remain responsible for their national HTA conclusions and for use, pricing and reimbursement decisions.

What manufacturers should take from this

Pure Global analysis: an expert-panel opinion can lead to a further Union-level assessment after certification. Manufacturers of Class IIb or Class III devices going through CECP, and Class D IVD developers seeking expert-panel views, should treat a possible JCA as part of launch planning, not as a separate reimbursement event that can be handled later. After recommendation, prepare the certificates of conformity and instructions for use requested for scoping, and arrange access to the HTA IT Platform. Once the Commission requests the dossier, resource the 100-day response period.

Selection is expected quarterly, and only a certified device can be selected. The decision and newsletter do not give either device's dossier deadline; affected developers should use the Commission's request to establish their submission timetable.