MedTech Europe – with the backing of 39 national associations, including BIVDA – is urging the EU to take action on the medical technology regulations (IVDR and MDR) to ensure the availability and competitiveness of medical devices.
In an open letter to European Commissioner for Health & Food Safety, Stella Kyriakides, MedTech Europe asks for Commissioner Kyriakides’s leadership to make reform of these regulations her priority and to urge her successor to do the same to solve their ongoing serious implementation challenges. The industry body believes action is needed to reverse the exodus of innovation from Europe and to prevent further discontinuations of medical technology intended to protect patient safety and public health.
MedTech Europe is proposing three areas of action:
1. As an immediate outcome of the targeted evaluation running until end-2025 – a package of legislative reforms for each of the two regulations should be developed to ensure that these regulations deliver on their original objectives. It is imperative that the improved regulatory systems meet three criteria: being efficient, innovation-friendly and well-governed.
2. As urgently as possible – several ‘bridging measures’ are needed to support device availability and the viability of the medical technology industry. These measures cannot wait until the targeted evaluation is concluded and full packages of legislative reforms are written and published into EU law, which will take years. These measures should have sufficient legal weight to achieve the following:
- a) Time and costs for certifying devices must be significantly reduced and made predictable. Immediate action here is vital both for helping to halt the ongoing disappearance of today’s devices and for attracting investment in bringing innovations to Europe
- b) Assessment of changes to medical technologies must be made more efficient to allow the latest technologies to reach patients swiftly
- c) An accelerated pathway for breakthrough innovation should be put in place to bring first in class products to Europe first or in parallel with other jurisdictions
- d) Adapt certification to follow a life-cycle approach. This would eliminate a major disincentive for manufacturers to certify and maintain devices under the medical technology regulations and help prevent anticipated certification bottlenecks during the transition periods to the regulations.
3. On an ongoing basis – specific measures to improve the implementation of the regulations should continue to be pursued through existing work streams and tools (including guidance and implementing acts). Examples of needed measures include reducing the technical documentation sampling burden, adopting wide use of electronic instructions for use and having the EU join the Medical Devices Single Audit Program.
Click here to read MedTech Europe’s open letter to Commissioner Kyriakides.