Navigating PFAS: Preparing For Regulatory Hurdles In Medical Devices

By Leonard Harris, Senior Scientific Advisor, Eurofins Medical Device Services

Per- and polyfluoroalkyl substances (PFAS) — commonly referred to as “forever chemicals” — are increasingly under public and regulatory scrutiny due to their persistence in the environment, potential health risks, and widespread presence in everyday products. Resistant to degradation, PFAS accumulate over time and are routinely detected in drinking water, food, clothing, and even medical devices. Stents, catheters, syringes, and bandages often contain PFAS, and it is unlikely that a medical device is entirely free of them. Yet many manufacturers mistakenly assume that because they do not intentionally add PFAS, they are unaffected.

In reality, PFAS can enter the supply chain through raw materials, manufacturing equipment, facility infrastructure, or packaging. Their presence in medical devices can trigger serious consequences: elevated carcinogenic and toxicological risks, environmental contamination and bioaccumulation, heightened legal exposure, and reputational damage as public awareness grows. Although U.S. regulations have not yet mandated PFAS analysis in medical devices, proactive assessment is critical to future-proofing compliance, preventing litigation, and demonstrating responsible product stewardship. This requires systematic screening of raw materials, finished devices, and packaging to identify and control sources of PFAS. Transparent, defensible GMP testing strategies will be essential — not only to stay ahead of evolving regulations, but also to address growing consumer and regulatory demands for accountability.

Learn how to be more proactive by implementing robust PFAS testing and control strategies to safeguard patient health, protect your brand, and stay ahead of evolving regulations.