EU Joint Clinical Assessment for medical technologies – Ready to launch?

Posted on 02.07.2026

The EU Health Technology Assessment Regulation (EU HTAR) became applicable in January 2025 and is materialising for a selection of high-risk medical devices this year. The Member State representatives (HTA Coordination Group) driving the implementation of the EU HTAR have recently agreed to select the first two cardiac implantable medical devices to undergo Joint Clinical Assessment (JCA) at the EU level. Additional recommendations for selection of technologies are expected later this year.

Also this year, a pilot is being launched to help translate the Medical Device Coordination Group (MDCG) Guidance on breakthrough devices into practical implementation. As Europe moves towards the first de facto pathway to support breakthrough innovation in the medical technologies field, MedTech Europe calls for JCA procedures that support the key principles of this pathway and deliver innovation faster to patients.

What is needed for a workable system? Bringing all relevant expertise, including Health Technology Developers’, Medical Societies’, Patients Groups’ input, to the table when informing the scope of JCAs. The medical technologies sector advocates for proportionate evidence requirements and data-driven assessments that are relevant to decision-makers and adapted to the subgroup of highly innovative high-risk devices in scope for JCA.

What does not work? Limited predictability in the selection of technologies, timelines and procedures for JCA that are not fit for the evidence generation model for the technologies assessed, non-specific guidance documents lacking stakeholders’ input.

The upcoming evaluation exercise of the EU HTAR is an opportunity to highlight what is still needed to establish a system adapted to and supportive of access to medical technology innovation.

For more information, please contact Teresa Barcina Lacosta, Manager Health Technology Assessment