- The trade association representing the medical technology industry in Europe is calling for comprehensive structural reform to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) framework to prevent delays in treatment for patients.
- MedTech Europe, in an open letter to EU Commissioner for Health and Food Safety Stella Kyriakides, said on Friday the MDR and IVDR regulations have not fully achieved their intended objectives, despite more than six years of implementation. The letter was also signed by 34 national trade groups.
- “Delayed access may become a reality as the latest state-of-the-art prevention, screening, treatment, and care services will not be available at the speed that some patients might need,” the trade groups said in their letter.
The EU Council earlier this year provided more time for notified bodies that certify medical devices in Europe to comply with the regulatory overhaul, pushing deadlines out to 2027 and 2028 amid a backlog of recertification requests. Companies that operate in the European market previously were expected to have devices recertified by May 2024 under the new regulatory framework, but concerns about potential shortages of medical devices in the EU prompted the European Commission in March to extend the timeline.
The medical device groups, in Friday’s letter, said the European Commission and Medical Device Coordination Group have done “considerable work” to address short-term implementation challenges. Nonetheless, they said, “there are structural issues in the regulations which cannot be solved simply through their implementation. The regulatory framework is unpredictable, complex, slow and costly.
“The result is that medical technologies – both those already on the market and future innovations − struggle to reach European patients and health systems.”
Changes are needed to make the CE marking system more efficient and reduce the administrative burden under the new regulations, the groups argued.
The letter also called for the inclusion of an “innovation principle” that “swiftly connects the latest medical technologies to European patients and health systems through dedicated assessment pathways and early dialogues with developers.”
The groups proposed the establishment of a single, dedicated structure to oversee the regulatory system, including the designation and oversight of notified bodies.
“It is of paramount importance that we ensure that medical technologies continue to reach patients and health systems in a timely manner,” the trade groups wrote.