Insights on EU Joint Clinical Assessment for High-Risk Medical Devices

EU Joint Clinical Assessment is a distinct, harmonised process that operates separately from CE marking. It produces comparative clinical evidence on selected high-risk devices to support more consistent national reimbursement decisions across EU member states. Insights from the EU HTA Regulation webinar for health technology developers on high-risk medical devices and IVDs, held on 19 June 2026, underscore the importance of early preparation.

Targeted Device Pipeline

Only a limited number of Class III implantable devices, certain Class IIb active devices, and Class D in vitro diagnostics will enter the EU Joint Clinical Assessment each year. Manufacturers must therefore track quarterly updates from the European Medicines Agency expert panel and prepare evidence packages once a device meets at least one selection criterion and receives a favourable panel opinion.

PICO-Driven Scoping

A standardised Population, Intervention, Comparator, and Outcome (PICO) framework is developed within a 60-day scoping phase that actively incorporates feedback from all member states. Assessors then apply a clear evidence hierarchy that favours direct randomised controlled trials, followed by anchored indirect comparisons, while mandating systematic literature reviews for every PICO element.

Quarterly Selection and Timelines

Expert panel recommendations flow quarterly to the HTA Coordination Group, which evaluates devices against criteria such as unmet medical need, first-in-class status, patient or system impact, artificial intelligence integration, cross-border relevance, and Union-wide added value. The resulting EU Joint Clinical Assessment report is targeted for completion within one year of CE marking, supported by structured developer interactions including scope clarification meetings and factual accuracy checks.

Strategic Evidence Readiness

Health economics and outcomes research teams must now build proficiency in systematic review methodology, advanced statistical techniques, and HTA-compliant synthesis to meet rigorous dossier standards submitted via a secure digital platform. Proactive tracking of expert panel opinions, early PICO mapping, and parallel scientific consultations will help manufacturers align clinical development plans with both the joint European process and subsequent national reimbursement negotiations. Further details are available on the European Commission’s Joint Clinical Assessments page.