Europe's First Medical Device JCAs Are Here: What the Selection of SAPIEN M3 and HighLife Tells Us About the Future of Medtech JCA Implementation

The EU Joint Clinical Assessment (JCA) for medical devices and in vitro diagnostics (IVD) has officially moved from theory to reality.

On 6 October 2026, the European Commission announced the first two medical devices selected for JCA under the EU HTA Regulation: the SAPIEN M3 Transcatheter Mitral Valve Replacement (TMVR) System from Edwards Lifesciences and the HighLife Trans-Septal Mitral Valve Replacement System from HighLife SAS. Both technologies address severe mitral regurgitation in patients with limited treatment options and represent highly innovative, first-in-class structural heart interventions. The assessment of SAPIEN M3 will be led by ZIN (Netherlands), supported by DMP (Norway) as co-assessor, while HAS (France) and AOTMiT (Poland) will serve as assessor and co-assessor, respectively, for HighLife.

These are the first devices to enter the JCA process, with an evidence packages reflective of many novel medical devices today, creating an important opportunity to understand how assessors will evaluate comparative clinical effectiveness and manage evidence uncertainty.

From an HTA perspective, neither technology represents an "easy" assessment. Like many breakthrough medical devices, the evidence packages have been generated in relatively specialised patient populations where traditional randomised comparative studies can be challenging. Much of the available evidence has focused on demonstrating procedural feasibility, safety and clinical improvement in patients who have exhausted conventional treatment options.

This creates a challenge for the JCA assessors, and provides the first real-world test of whether the framework can accommodate the realities of evidence generation for innovative medical devices whilst maintaining robust comparative assessment standards.

How will the framework evaluate technologies where:

• head-to-head comparative evidence may be limited

• relevant comparators and treatment pathways may differ across healthcare systems

• patient populations are highly selected

• evidence packages rely heavily on single-arm studies without longer-term follow-up

During Lightning Health’s recent webinar on the EU JCA for Medical Devices and IVDs, one message emerged repeatedly: the challenge is not related to proving that a device works, rather it is about proving its relative clinical effectiveness across multiple European healthcare systems simultaneously. With this in mind, the assessment of SAPIEN M3 and HighLife will be closely watched for several reasons:

PICO complexity may become the defining issue

Depending on the population ultimately defined, assessors may consider surgery, transcatheter edge-to-edge repair (TEER), medical management or other treatment approaches relevant comparators. One of the key findings from the initial pharmaceutical JCAs has been the challenge of aligning available evidence with the breadth of requested PICOs.

Medical device manufacturers face a similar risk. Where direct comparative evidence is unavailable, manufacturers may increasingly need to rely on indirect comparisons. The first device JCAs may therefore provide an early indication of how assessors view the credibility of different evidence synthesis approaches, particularly where robust anchored comparisons are not feasible.

Uncertainty remains around how findings will be interpreted nationally

A JCA report assesses clinical evidence at a European level; it does not provide recommendations for adoption or reimbursement at Member State level. Whilst the assessment may identify areas of uncertainty, how individual Member States interpret those findings within national reimbursement and funding decisions remains largely untested. Moreover, not all Member States currently assess medical devices and IVDs, so the first device JCAs will also test how national systems will use the outputs.

Preparing for future medical device and IVD JCAs

Although both of the first selected devices are cardiovascular technologies, their selection offers broader lessons for manufacturers of any device or IVD that may be eligible for JCA:

1. JCA readiness should begin before pivotal evidence is locked

Manufacturers should evaluate whether planned evidence generation is capable of supporting comparative assessment, not just regulatory approval.

2. PICO mapping is becoming a strategic necessity

The challenge is not identifying every possible PICO, but identifying and prioritising those most likely to influence access across key European markets.

3. Comparator strategy can no longer be an afterthought

Manufacturers should understand early which comparators are most likely to be requested and whether sufficient evidence exists to support those comparisons.

4. Consider engaging through Joint Scientific Consultation

For selected technologies, JSC offers a unique opportunity to pressure-test evidence-generation plans before critical development decisions are locked in.

What happens next?

The selection of SAPIEN M3 and HighLife marks the beginning of a new era for medical device assessment in Europe, and the Commission has indicated that medical device selection is expected to occur on a quarterly basis, meaning further technologies are likely to enter the process in the coming months; indeed, two further technologies had already been recommended for selection in September.

The first reports are unlikely to answer every question, but they will provide important early signals on how the JCA framework will be applied to medical devices in practice, particularly in relation to PICO scoping, comparator selection, evidence expectations and the handling of uncertainty. For manufacturers of potentially eligible devices and IVDs, the implications extend beyond the technologies currently undergoing assessment. The precedents established through these early JCAs should help inform future evidence strategies and reinforce the importance of anticipating comparative evidence requirements well before a technology enters the JCA process. Ultimately, these first assessments will provide a clearer picture of what JCA readiness looks like for the wider medical device and IVD industry.

Article by Adam Ben Taieb

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