Privileged Talk on Enhancing Access to Innovative Medical Devices
At SDA Bocconi premises, the event titled “Privileged Talk: Adopting a Lifecycle Approach to Enhance Access to Innovative Medical Devices: Regulatory Insights and Future Perspectives Amid the Ongoing Targeted Evaluation” gathered experts from industry, regulators, and academia. The discussion focused on the ongoing evaluation of the EU Medical Device Regulation (MDR), Early Feasibility Studies (EFS), the potential for an Accelerated Access Program, and the evolving link between the MDR and the Health Technology Assessment Regulation (HTAR).
Flora Giorgio (DG SANTE, European Commission), along with regulators, industry leaders, and other stakeholders, addressed key challenges and proposed solutions to refine the MDR framework. The event aimed to gather insights from various experts to enhance access and innovation in the medical device sector. Giuditta Callea (SDA Bocconi) presented the EU project on EFS to improve evidence generation, while Rosanna Tarricone (SDA Bocconi) proposed an Accelerated Patients’ Access Program for breakthrough medical devices. Marco Marchetti (AGENAS) discussed integrating the Joint Clinical Assessment (JCA) with MDR, and Flora Giorgio outlined the Commission’s priorities to improve predictability and reduce burdens while safeguarding patient safety. Andrea Rappagliosi (Edwards Lifesciences) highlighted the slow certification processes delaying innovation, and Phil Collis (Patient Advisory Group Representative) emphasized the need for stronger post-market surveillance.
The consortium emphasized the importance of collaboration among all stakeholders to boost efficiency, predictability, and innovation while safeguarding patient safety. The objectives are to improve the MDR to facilitate better access and innovation in the medical device sector, resulting in enhanced regulatory processes, faster certification, and stronger post-market surveillance.
The HEU-EFS project, involving 22 public and private consortium partners, aims to systematize information regarding the regulatory framework and pre-market evidence generation programs, develop and validate a robust methodology, and create a conducive environment for undertaking EFS in the EU.
