MedTech Europe urges parliamentarians assess the challenges of the EU MDR 2017/745

November 9, 2022

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.

Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE)

MED IVD HEALTHTECH S.L ha sido beneficiaria de la subvención de contratos de trabajo de la Comunidad de Madrid, cofinanciado por el Fondo Social Europeo dentro de la Ayuda a la Recuperación para la Cohesión y los Territorios de Europa (REACT-UE), a través del Programa Operativo Regional FSE, en el marco del Programa Impulso a la Contratación Estable de Jóvenes para la Recuperación Económica, gestionado por la Dirección General del Servicio Público de empleo de la Consejería de Economía, hacienda y empleo de la Comunidad de Madrid.

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