Open letter to Commissioner Olivér Várhelyi: safeguarding availability and innovation in 2025 and beyond

On 19 September 2025, together with 35 national associations, MedTech Europe has sent an open letter to European Commissioner for Health & Food Safety, Olivér Várhelyi, calling for urgent action to secure the availability of medical technologies for European citizens and health systems.

With the European Commission set to present the revision of Europe’s rules for medical devices and in vitro diagnostic (IVD) medical devices by the end of 2025, MedTech Europe stresses 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.

2.Urgent (short-term) relief measures by the end of 2025 or early 2026, including:

• An Implementing Act with harmonised 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 & paediatric devices and breakthrough innovations.
• A targeted postponement of re-certification requirements for devices already certified under the medical technology regulations

In addition, MedTech Europe urges 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, Member States, and stakeholders to co-create practical solutions that secure faster and continued access to safe and effective medical technologies, strengthen Europe’s health systems, embrace digitalisation and foster trust in a future-ready regulatory framework.

For further information, please contact Petra Zoellner, Director Regulatory Affairs or Merlin Rietschel, Senior Manager Medical Devices.