Priorities for Medical Device Regulatory Approval: A Report From the European Society of Cardiology Cardiovascular Round Table

In this official statement, the European Society of Cardiology advocates for the evolution of the Medical Device Regulation (MDR) system to facilitate priority access for innovative devices addressing unmet needs and orphan cardiovascular medical devices in the European Union. It also calls for global regulatory harmonization to streamline cardiovascular medical device authorization across jurisdictions, enabling reprocessing of single-use devices, and encouraging early feasibility studies to assess initial safety and performance, thus accelerating device development and adoption. This report presents a proposal to improve medical device authorization worldwide while protecting patient safety.