Ahead of discussions at the upcoming Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on 3 December 2024, MedTech Europe, COCIR, eurom, and FIDE have published a statement on the future of the medical technology frameworks.

Medical technology manufacturers fully support the objectives of the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which aim to “establish robust, transparent, predictable and sustainable regulatory frameworks for medical devices which ensure a high level of safety and health whilst supporting innovation”. To date, we believe these objectives have not been fully met.

We recommend the EU Institutions to put forward short-term measures that should be implemented without delay and that should have sufficient legal weight to achieve their intended objective, as well as mid-term measures to reform the regulations. The availability of medical technologies to patients in Europe is at stake and therefore broad and comprehensive reforms are needed to support public health, patient safety, and the future sustainability of Europe’s health systems.