The Evolving EU Policy Landscape: Are We on the Right Path to Improve Clinical and Economic Outcomes Research of Medical Devices?

The EU regulatory environment for medical devices (MDs) is evolving. While marketing approval for MDs in the EU has historically focused on the proof of safety as a minimum requirement, and approval could be granted based on pre-clinical evidence alone, the new EU regulation on MDs sets stricter evidential requirements for market access. In addition, the proposed regulation on the European cooperation on health technology assessment (HTA) may affect coverage and reimbursement decisions by national HTA bodies by introducing joint clinical assessments at the EU level, and promoting a closer collaboration among industry, regulators and payers early on in the product development process. In the light of this new regulatory landscape, the goal of the session is to discuss how to improve clinical and non-clinical evidence generation at each stage of product life cycle to fit requirements and needs of all stakeholders.

Rosanna Tarricone, COMED Scientific Advisor, and Carlo Federici, COMED Researcher, brought the COMED perspective in the debate