EU HTA update: Medical device JCAs move forward as fourth medicinal-product assessment is discontinued

The latest meeting of the EU HTA Coordination Group has moved JCAs of medical devices a step closer, while another medicinal-product JCA has been discontinued after the developer’s dossier failed to meet regulatory requirements. Newly published details on the sintilimab assessment provide further insight into the evidence and reporting standards expected from health technology developers.

The Baseline

• The HTA Coordination Group has recommended two medical devices for selection for JCA, with further details to be published once the European Commission decision is adopted and the devices are certified.
• The JCA of sintilimab has been discontinued after its updated dossier failed to meet requirements under the HTA Regulation.
• The missing information included study-level data, documentation of information retrieval and evidence needed to assess the validity of indirect comparisons.

The Member State Coordination Group on Health Technology Assessment (HTACG) has recommended two medical devices for joint clinical assessment (JCA), marking another step towards implementation of the JCA framework beyond medicinal products.

At its 23rd meeting on September 16, 2026, the HTACG adopted its second recommendation for the selection of medical devices and in vitro diagnostic medical devices for JCA. The developers concerned will be informed whether their technologies were recommended, with the final selection to be made public once the European Commission decision has been adopted and the devices have been certified.

Medical devices and in vitro diagnostics are subject to a separate selection process rather than automatic inclusion in JCA. The latest recommendation therefore provides an early indication of how the device pathway is beginning to move from implementation guidance into active assessment. The Commission has not yet disclosed the identities of the two recommended devices.

At the same meeting, the HTACG also discontinued another medicinal-product JCA after the Commission concluded that the dossier submitted by the health technology developer failed to meet the requirements of Article 9(2), (3) and (4) of Regulation (EU) 2021/2282.

The assessment concerned sintilimab, developed by Innovent Biologics (USA), Inc. A separate Commission document published on September 15, 2026, sets out the information, data, analyses and other evidence that remained missing after the company submitted an updated dossier on September 1, 2026, in response to a second request from the Commission.

With sintilimab, this is now the fourth medicinal-product JCA to be discontinued. Three of those discontinuations have followed failure of the submitted dossier to meet the requirements set out in Article 9(2), (3) and (4), making dossier completeness an increasingly important implementation issue for health technology developers.

Comparative evidence under scrutiny

The assessment, led by the Institute for Quality and Efficiency in Health Care (IQWiG), Germany, as assessor, with the National Institute for Value and Technology in Health, Slovakia, as co-assessor, identified several gaps across the dossier.

These included incomplete study-level information and outcome reporting, missing documentation of information retrieval, and insufficient data to assess the exchangeability of studies used in indirect comparisons.

This was particularly important because all PICOs relied exclusively on indirect comparisons. The Commission concluded that the information provided was insufficient to assess the relative effectiveness and safety of sintilimab against the comparators. The dossier was also found to lack a sufficiently well-structured, transparent and consistent presentation of the data for assessment within the available JCA timeframe.

The discontinuation comes shortly after publication of the JCA report for onasemnogene abeparvovec (Itvisma) on September 7, 2026. With four medicinal-product JCAs now discontinued, four published and a further 15 still progressing through the JCA process, the emerging picture is one of close scrutiny of both the evidence submitted and the way it is documented.

For health technology developers, this sends a clear indication that JCA readiness is not only about having the relevant evidence available, but ensuring that the dossier is complete, methodologically transparent and sufficiently detailed for assessors to evaluate within the limited JCA timeframe.

With ISPOR Europe approaching, these early JCA experiences are likely to come under close scrutiny, particularly what they reveal about evidence requirements, dossier readiness and the practical implementation of the EU HTA Regulation.