EU4MEDTECH

EU4MEDTECH (European Framework for Advanced Medical Technology Evaluation and Follow-up) is a Horizon Europe project dedicated to strengthening how high-risk and innovative medical devices and in vitro diagnostic devices are evaluated and regulated across Europe. The project is developing the EU4MEDTECH Framework, a lifecycle-based approach to clinical and performance evidence generation, evaluation, and validation, supported by a digital platform designed to provide user-friendly tools for relevant stakeholders and streamline regulatory processes across pre-market and post-market stages.