Together with 35 national associations, MedTech Europe is urging Health & Food Safety Commissioner Olivér Várhelyi to quickly improve the continent’s medical device rules, noting the “immense strain” on the continent’s medical technology sector.

“The global competitiveness of Europe’s regulatory pathway for medical technologies must be significantly improved to ensure patients benefit from continued availability of medtech products, by
considerably reducing high life cycle cost and other unintended effects of the medical technology regulations,” the two-page letter read.

With the European Commission set to present the revision of Europe’s medical device and in-vitro diagnostic (IVD) rules by the end of the year, MedTech Europe stressed the need for both short-term relief measures and a sustainable, well-structured, well-governed and well-resourced regulatory framework to improve Europe’s global competitiveness.

To achieve these goals, the European medical technology industry puts forward the following priorities:

1. Legislative reform of the Medical Devices Regulation and the IVD Regulation that ensures a single and accountable governance and takes into account the specificity of each sector. “This reform should amend both the Medical Devices Regulation and IVD Regulation, taking into account the specificity of each sector,” the letter stated. “The Notified Body system is essential and should operate as a core pillar of the future regulatory framework. Notified Bodies should be overseen by a single and accountable governance structure which also ensures both the efficient functioning and the global competitiveness of the EU CE-marking system.”
2. Urgent (short-term) relief measures by the end of 2025 or early 2026, including:

• An Implementing Act with harmonized rules for notified bodies, maximum assessment timelines, defining the scope of changes to be notified and enabling earlier dialogue with manufacturers to set clinical expectations and mitigate the burden of re-certification.
• Pilots on regulatory pathways for orphan and pediatric devices, as well as breakthrough innovations.
• A targeted postponement of re-certification requirements for devices already certified under the medical technology regulations

In addition, MedTech Europe urged its Member States to invest more substantially and sustainably in the governance and resourcing (operational and science-based) of the medical technologies regulatory system, both today and once it is reformed.

“Our industry stands ready to work with the European Commission to deliver practical solutions that secure faster and continued access to safe and effective medical technologies, strengthen Europe’s health systems, embrace digitalization, and foster trust in a future-ready regulatory framework that works for patients and innovators alike,” MedTech Europe’s letter concluded. “By acting together now, Europe can ensure that the IVDR and MDR deliver on their promise: safeguarding patients enabling the EU medtech industry to grow, deliver innovations and sustain delivery of products while upholding the highest standards of safety and performance.”