Dive Brief:
- Medtech Europe said Tuesday the European Commission should urgently reform the Medical Device and In Vitro Diagnostic Regulations (MDR/IVDR).
- The open letter, which the trade group wrote with 39 national associations, calls for the EU to adopt reforms to ensure the regulations meet their original objectives and implement bridging measures to ensure the availability of devices and viability of the industry in the interim.
- European Commission President Ursula von der Leyen called for the new Commissioner for Health and Animal Welfare to assess the need for legislative changes. That commitment led to a debate at the European Parliament, during which a politician called the regulations a “bureaucratic monster.”
Dive Insight:
The start of a new Commission, with an updated agenda for 2024 to 2029, has sparked renewed interest in reforming the medtech regulations.
Medtech Europe shared its views on the need for legislative changes in a letter to Stella Kyriakides, the outgoing Commissioner for Health and Food Safety. In the letter, the industry groups urge Kyriakides and the successor, Olivér Várhelyi, to prioritize reforming the regulations to solve ongoing serious implementation challenges, reverse the “exodus of innovation” from Europe and prevent more discontinuations of medtech devices.
The letter stated that “Europe needs to invest in a regulatory environment that makes speed, coherence and simplification a priority.”
The letter outlines three sets of actions. Medtech Europe wants to see a package of reforms for the two regulations “as an immediate outcome of the targeted evaluation running until end-2025.” The industry groups are lobbying for changes that will “dramatically enhance efficiency and robustly increase Europe’s attractiveness for innovation.”
Medtech Europe is calling for the establishment of a single, dedicated governance structure to manage the regulatory system. The groups envision the structure underpinning a new system that is predictable, adaptable and “lean.” They added that the system should be less complex and burdensome than the current framework and have processes that “work end-to-end equally for the devices of today and the future.”
Recognizing that designing and adopting such a structure and system will take time, Medtech Europe is also pushing for the Commission to implement bridging measures “as urgently as possible.” The industry groups see the measures as a way to mitigate the perceived harms of the current framework while more permanent fixes are put in place.
Medtech Europe wants to see immediate action to significantly reduce initial conformity assessment timelines and costs. The trade groups are also calling for urgent steps to make assessments of changes to medical devices more efficient, establish an accelerated, 120-day pathway for breakthrough devices and align certification with the lifetime of medical technologies.
A third set of proposals addresses specific, ongoing measures that could improve implementation of the regulations. The proposals include a call for the EU to work towards enabling electronic instructions for use for all medical technologies and to promote global regulatory convergence.
The Commission has yet to publicly respond to the letter. However, Věra Jourová, vice-president for values and transparency at the Commission, set out her thinking on regulatory reform during a debate in the Parliament days before the lobby group sent the letter. Noting that the EU had already extended the transition periods, Jourová warned against rushing and said, “We must get this right.”
Jourová was speaking after some parliamentarians had called for proposals within 100 days of the start of the new Commission. Peter Liese, one of the politicians who made the 100-day demand, said the EU had created “a bureaucratic monster with loads of rules that do not increase safety, but increase costs.”
