ISSUE: 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. OVERVIEW: The panel will be structured as a debate, starting from a short presentation on the different perspectives, and followed by a discussion moderated by Rosanna Tarricone. Flora Giorgio will outline how the new EU Regulation on MDs and the proposed regulation on EU cooperation on HTA will impact clinical and non-clinical evidence generation, and ultimately accelerate patient access to potentially beneficial medical devices. Carlo Federici will provide an overview of the methods for the early assessment of MDs that can inform clinical development pathways as well as regulatory and reimbursement policies. Jean Luc Lemercier will present the challenges faced by the industry about pre-clinical and clinical outcomes research within the changing EU regulatory framework. Rosanna Tarricone will introduce the panel and conclude by synthetizing the different perspectives explored in the panel and by identifying main opportunities and challenges of an efficient, fit-for-purpose evidence generation process of MDs