Health Technology Assessment (HTA)

Description: With the EU Health Technology Assessment (HTA) Regulation (EU) 2021/2282 entering phased implementation, medical device manufacturers face a fundamental shift in how clinical evidence must be generated, interpreted, and re used across regulatory and market access pathways. Starting in 2026, selected Class III and certain Class IIb devices will be subject to EU level Joint Clinical Assessments (JCAs), introducing a new layer of scrutiny focused on relative clinical effectiveness and added value—beyond traditional MDR compliance.

This session provides a structured, practical overview of the EU HTA framework as it applies to medical devices, with a clear focus on how HTA requirements interlink with existing MDR clinical evaluation processes. Participants will first gain a high level understanding of the HTA system—its key actors, timelines, device selection criteria—and the roles of Joint Scientific Consultations (JSCs) and Joint Clinical Assessments (JCAs).

A unifying thread is evidence re use: how to design MDR compliant clinical strategies that also satisfy HTA, including leveraging MDR Article 61(2) Expert Panel advice to shape the Clinical Development Plan, aligning with JSC, and using the Clinical Evaluation Consultation Procedure (CECP) where appropriate. Building on this, we will show—with recent guidance and practical examples—how study designs, endpoints, comparators, and real world evidence (RWE) can be structured to support CE marking while simultaneously preparing for future HTA assessments.

Attendees will leave with a clear, actionable view of how to streamline evidence generation across regulatory approval and reimbursement, and how to prepare strategically for the evolving EU HTA landscape.