Different regulatory framework for medical devices and drugs in the European Union: Impact on clinical research and health technology assessments.

Policy changes could be implemented in order to promote an integrated evidence-based assessment system for a better allocation of resources in healthcare, namely: a consensual classification of medical devices from an HTA perspective, which could be used as a guide for generating outcomes in clinical investigation, and the adoption of conditional coverage practices including mandatory post-approval evidence development for performing periodic technology assessments.