Presentation (CTI)

OBJECTIVES: Developers carry extensive obligations under the Joint Clinical Assessment (JCA) framework — but where is the instruction manual? Unlike other major EU regulatory systems, the framework lacks a comprehensive applicant-facing procedural architecture. This study examined whether the absence of dedicated applicant guidance, procedural notices, and structured pre-submission interaction creates legal uncertainty and implementation risk.
METHODS: A comparative legal and policy analysis was conducted using Regulation (EU) 2021/2282, implementing regulations, HTACG methodological documents, and European Medicines Agency (EMA) procedural frameworks. The analysis evaluated the availability, accessibility, and legal status of procedural instructions applicable to HTDs and compared these arrangements with established EU regulatory practices governing medicinal product authorisation.
RESULTS: The review identified a structural asymmetry between obligations imposed on health technology developers (HTDs) and the procedural instruments available to support compliance. While extensive methodological guidance exists, much of it is directed toward assessors rather than applicants. No equivalent to the EMA Notice to Applicants exists within the JCA system. Consequently, manufacturers must infer submission requirements from assessor-facing documentation whose legal status and practical implications are not always clear. This creates variability in interpretation, increases compliance risk, and reduces procedural predictability. The absence of structured dossier-stage pre-submission interactions further limits opportunities to clarify expectations before assessment begins. These deficiencies collectively weaken legal certainty and increase the likelihood of procedural disputes.
CONCLUSIONS: A framework succeeds on predictability as much as on method. A clear, applicant-facing guidance architecture — the JCA equivalent of a notice to applicants — would cut avoidable disputes and build confidence in the system.