Omics NoE’s response to the European Commission’s HTA consultation-Joint Clinical Assessments of medical and in vitro devices

JANE-2 NoE on Omics responded the European Commission’s HTA consultation on joint clinical assessments of medical devices and in vitro diagnostic medical devices, conducted in June 2025. The submitted paper identifies 8 key issues — from outdated evidence formats to unrealistic procedural timelines and the absence of clear standards for multi-omics or AI-based tools. In response, a Coordinated Package of Solutions is proposed: adapting dossier templates for real-world and machine learning evidence; building IT infrastructure that supports secure, large-scale data sharing; and enabling rolling submissions that align with the pace of scientific discovery. JANE-2 urges EU policymakers to align the regulation with real-world needs.