PFAS restriction: Commission highlights Importance of critical Medical Applications

The European Commission has responded to a parliamentary question on the potential impact of the planned PFAS restriction on medical devices. It made clear that the assessment of the restriction proposal has not yet been completed. The proposal was submitted in 2023 by five national authorities and is currently being reviewed by the European Chemicals Agency (ECHA).

The medical device market is being considered separately in the procedure. The following questions are among those at the centre of the assessment:

• Which alternatives to PFAS or fluoropolymers are available?
• Are these alternatives comparable in terms of safety, performance, and technical and clinical suitability?
• What economic and social consequences could result from possible restrictions?

PFAS in medical devices

Fluoropolymers are used, among other things, in vascular grafts, catheters, guidewires and surgical meshes. During the consultation, representatives of the medical technology sector pointed out that these materials possess important properties for certain applications. In particular, they cited biocompatibility, durability and reliable performance. According to the industry, there are currently no technically and clinically equivalent alternatives for many of these applications.

The public consultation on the draft opinion of the ECHA Committee for Socio-Economic Analysis (SEAC) ended at the end of May 2026. The committee is currently evaluating the comments received and is then expected to finalise its opinion. Together with the opinion of the Committee for Risk Assessment (RAC), it will form the basis for the European Commission's further proposal.

In its response, the Commission also refers to the "Chemicals Industry Action Plan", published in July 2025. Under this plan, the continued use of PFAS in critical industrial applications could be permitted if no suitable alternatives with comparable safety and performance are available. The Commission explicitly names healthcare as an example of such an area.

However, no specific exemption for certain medical devices has yet been confirmed. The final design of any PFAS restriction will first depend on completion of the scientific and socio-economic assessments by the ECHA. For manufacturers using fluoropolymers in medical devices, the explicit consideration of critical applications in healthcare is nevertheless an important signal.