Croatian MEP Tomislav Sokol (PPE) has raised concerns that the European Commission's proposed restriction on per- and polyfluoroalkyl substances (PFAS) could jeopardise the availability of critical medical devices in the EU, potentially harming patient access and increasing healthcare costs. In a written parliamentary question submitted on 10 June 2026, Sokol points to stakeholder evidence submitted to the European Chemicals Agency (ECHA) consultation, which indicates that fluoropolymers – a subset of PFAS – are essential in devices such as vascular grafts, catheters, guidewires and surgical meshes due to their biocompatibility, durability and resistance to degradation. The current Annex XV restriction dossier acknowledges that for many of these applications, no technically and clinically viable alternatives exist and the potential for substitution is low.
Sokol asks the Commission three specific questions: first, what actions it is taking to comprehensively assess the impact of the proposed PFAS restriction on the availability, safety and performance of critical medical devices and their role in clinical pathways; second, if a risk to availability is identified, what regulatory or policy measures it intends to take to prevent disruption to patient access; and third, what steps it will take to ensure the long-term availability of these essential medical technologies in the EU.
The question reflects a tension between the EU's environmental ambition to phase out PFAS – a group of persistent chemicals linked to health and environmental risks – and the need to safeguard medical devices where alternatives are lacking. Stakeholders from the medical technology sector have warned that a broad restriction could lead to reduced availability of established therapies, increased reliance on more invasive procedures carrying higher risks, and higher healthcare costs due to complications, longer hospital stays or repeat interventions.
Sokol's question is directed to the Commission, which typically must reply within approximately six weeks. The answer will signal whether the Commission intends to carve out exemptions for critical medical applications or pursue a more gradual phase-out to avoid supply disruptions. The issue pits public health and environmental protection against patient safety and healthcare system resilience, with medical device manufacturers, healthcare providers, patients and EU regulators as the key stakeholders affected.