ISSUE: . COVID-19 emphasized the issue of evidence generation for access to market of medical devices (MDs). In times of urgency and emergency, governments struggled to keep the balance between patients’ and professionals’ needs to access the technologies as quickly as possible and the necessity to assess safety and effectiveness. The final effect was that in many cases governments arrived too late and hospitals had to do it themselves with huge discrepancies across jurisdictions. One interesting stream of research is the one that considers clinical evidence generation across the entire lifecycle of MDs. This is what the new EU Regulations on MDs and vitro diagnostics embrace. Furthermore, if the Commission Proposal for an EU HTA Regulation were adopted, it would provide the possibility for Member States to further strengthen the current HTA systems at national, regional and hospital level and the whole lifecycle of high-risk implantable MDs. The Proposal would enable a comprehensive vision of clinical evidence generation for some high risk MD. This may have an impact in the MedTech ecosystem. Are we ready? There is an urgent need to explore this issue with all stakeholders.

OVERVIEW: . Flora Giorgio (10’) will discuss the opportunities the proposed EU HTA Regulation could bring to the systems, including its synergies with the Regulatory framework, from the prospective of the European Commission. Laura Sampietro-Colom (10’) will discuss the challenges of clinical evidence generation across the lifecycle of technologies from the perspective of HTA doers and users. Andrea Rappagliosi (10’) will represent the MedTech industry and discuss whether manufacturers are ready to invest in a long-term, strategic vision that would govern the development of clinical studies across the entire lifecycle. 10’ will be allocated to the introduction of the panel issue and 20’ will be allotted to discussion. The entire MedTech ecosystem would benefit from attending.