PFAS in medical devices

There is currently no general ban on PFAS as a substance group in medical devices. However, regulatory scrutiny is increasing and several individual PFAS are already restricted or prohibited. In the EU, for example, a comprehensive PFAS group restriction under REACH is currently being assessed by ECHA and could significantly impact many applications, including medical devices. Based on the current regulatory discussions, specific derogations for medical devices are likely to be considered, for example where the use of PFAS is essential for health or safety, no suitable alternatives are available and a positive benefit-risk profile can be demonstrated. Toxicological assessments play a key role by supporting benefit-risk justification.

The European Chemicals Agency (ECHA) aims to complete its scientific evaluation of the proposed EU-wide restriction of PFAS by the end of 2026. Based on these opinions, the European Commission will prepare a legislative proposal under REACH, which will then go through the EU decision-making process. The restriction proposal foresees to include a transition period and (time-limited) derogations for certain uses. Nevertheless, while the precise scope of transition periods and derogations is not yet final and may evolve during the REACH legislative process, companies should already prepare for significant regulatory impacts in the coming years.

PFAS that may be present in medical devices can be evaluated as part of the biological safety assessment in accordance with the EU MDR 2017/745 and the ISO 10993 series, including toxicological assessment and contribution to the overall benefit–risk evaluation. Although the MDR 2017/745 and REACH are separate regulatory frameworks, the proposed EU-wide PFAS restriction under REACH, that is currently under evaluation, is increasing scrutiny on PFAS use across industries, including medical devices. Manufacturers may in future need to justify the continued use of PFAS, for example with regard to patient safety, technical necessity and the availability of suitable alternatives. A robust toxicological assessment of PFAS can therefore not only support MDR 2017/745 compliance but also help manufacturers prepare for evolving regulatory expectations under REACH.

Potential alternatives to PFAS do exist, but their suitability must be assessed on a case-by-case basis. In practice, the availability of viable alternatives can be limited, particularly for applications requiring specific properties.

PFAS alternatives should be evaluated considering technical feasibility, performance requirements and toxicological profiles. This includes assessing whether the alternative can deliver equivalent functionality, meets safety and regulatory standards, and provides an improved environmental profile without introducing new risks.

A structured, conservative toxicological approach can be applied, using read-across, threshold concepts and scientifically grounded, relevant worst-case assumptions to ensure a robust assessment under uncertainty.

PFAS in pharmaceuticals are exempt under REACH when used in medicinal products (APIs or excipients), but PFAS used in manufacturing or packaging may still fall under REACH requirements. However, the use of PFAS as APIs or excipients is unlikely due to their low chemical and biological reactivity.