Assisting with the EU Medical Devices Regulation Europe faces imminent shortages of medical equipment needed by hospitals and clinicians to treat patients. This dangerous disease affects both new and old devices.
The EU institutions must take urgent and decisive action. The Medical Devices Regulation (MDR) implementation is producing significant certification challenges. The situation is severe, threatening the lives of people all throughout Europe. The EU must act quickly to ensure access to medical equipment. MedTech Europe strongly encourages legislators to support the adoption of ambitious EU-level legislative solutions that ensure patients and health systems have access to all medical device categories.
On May 26, 2021, the MDR went into full effect. The medical technology industry has long supported MDR goals and has made tremendous progress in implementing the new standards. Despite the efforts of all stakeholders, the new system does not yet function in a predictable and sustainable way for everybody.
Without quick legislative action, the ongoing supply of critical medical devices is jeopardized, putting patients’ healthcare in Europe and throughout the globe at risk.
- Due to certification constraints prior to the end of transition period on May 26, 2024, only a tiny proportion of the 25,000 old Directives certificates have converted to MDR to date.
- Under the MDR, the average time to certification has more than quadrupled to 13-18 months across all device categories.
- There are currently 19 non-legislative solutions to the MDR concerns that the industry endorses, but none of them have been adequate to solve structural capacity difficulties and the escalating urgency of expired certificates.
Without prompt legislative action, the continuing supply of critical medical equipment is jeopardized, threatening healthcare services to people in Europe and throughout the world.