The European Heart Network (EHN) welcomes the opportunity to contribute feedback to the Commission’s targeted evaluation of EU rules on medical devices and in vitro diagnostics. Improved access to life-saving medical devices is crucial, particularly for cardiovascular patients, with a focus on paediatric and rare disease care. A more balanced regulatory approach is needed, one that includes a priority tier system for devices addressing unmet needs, similar to the support mechanisms available for pharmaceuticals.
To ensure the continued availability of essential devices, regulatory flexibility should be incorporated, such as the introduction of “grandfather clauses” similar to those used in the U.S. market. These provisions would allow established devices to remain on the market under updated regulations, thus preventing unnecessary shortages, especially for orphan and paediatric patients who depend on specialised technologies.
Additionally, addressing gender and paediatric cardiovascular disease disparities, improving national certification processes, and fostering innovation are essential steps to maintaining a steady supply of critical devices.
Click here to access the full feedback on the EU Commission’s website.