Restriction of PFAS use in medical devices – what next for medical device manufacturers?

Abstract

ABSTRACT Introduction The 2023 European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations have proposed imposing bans on the family of per- and polyfluoroalkyl substances (PFAS) in use across a multitude of sectors, including medical devices. This study will investigate the proposed PFAS regulations, their impact on the risks associated with PFAS use in general and in devices as well as the challenges that medical device manufacturers face due to the proposed PFAS regulations and the steps they are taking to address PFAS removal. Areas covered A literature review was conducted to assess the impact of PFAS on the Medtech industry and its customers over the period 2005–2025, utilizing academic databases such as SCOPUS, Web of Science and non-academic databases such as Google. Expert opinion The impact of global trends, particularly European (EU) REACH legislation, which proposes restrictions and removes PFAS use in medical devices, is both positive for public and environmental health and safety but will cause some uncertainty in terms of compliance and potential unforeseen implications.