Joint Clinical Assessment Requirements for Medical Devices and In-Vitro Diagnostic Medical Devices

The EU Health Technology Assessment Regulation (EU) 2021/2282 introduces Joint Clinical Assessments (JCAs) as a centralized framework for evaluating the relative clinical effectiveness and safety of selected health technologies across EU Member States.

For manufacturers of medical devices and in vitro diagnostic medical devices, the JCA process creates a new set of methodological and operational requirements. Developers must be prepared to identify all relevant evidence, address each PICO included in the final assessment scope, apply appropriate analytical methods, and submit a dossier that is complete, transparent, and suitable for independent verification.

The assessment focuses exclusively on the clinical domain. Pricing, reimbursement, cost-effectiveness, and broader value judgments remain the responsibility of individual Member States.

This White Paper provides a structured overview of the key methodological requirements for medical devices and IVDs, including:

• Evidence identification, literature searches, and source requirements
• Study designs, clinical outcomes, and patient-reported measures
• Risk of bias and use of real-world evidence
• Direct and indirect evidence synthesis
• Reporting and dossier submission requirements

The White Paper is particularly relevant for medical device and IVD manufacturers, market access teams, clinical development and biostatistics functions, regulatory affairs professionals, evidence generation specialists, and senior decision-makers preparing for EU Joint Clinical Assessments.