Diverging US and EU Positions Create Uncertainty Over PFAS in Medical Devices

Medical device manufacturers are facing uncertainty over the future use of certain PFAS materials after regulatory positions in the United States and Europe developed along different lines.

The issue centres on fluoropolymers such as polytetrafluoroethylene (PTFE), expanded PTFE, fluorinated ethylene propylene (FEP) and perfluoroalkoxy alkanes (PFA). These materials are used in a range of medical devices, including cardiovascular products such as stents, guidewires and vascular grafts.

The US Food and Drug Administration has indicated that it has not identified evidence suggesting that the fluoropolymer PFAS materials used in medical devices pose harmful public-health effects. The agency has also recognised that these materials have properties that can be difficult to replace because suitable alternatives with comparable safety and performance are not readily available.

The European regulatory landscape is different, with proposed restrictions under the EU's chemicals framework creating concerns for manufacturers that supply products to multiple markets. Companies therefore have to consider how potential European restrictions could affect materials used in devices while continuing to meet requirements in other jurisdictions.

Industry professionals cited by MD+DI said the absence of proven alternatives presents a particular challenge for manufacturers of higher-risk devices. Replacing established materials may require extensive evaluation to demonstrate that a substitute provides equivalent performance, safety and reliability.

The differing regulatory approaches have consequently added complexity to global medical-device material strategies. Manufacturers must monitor developments in both regions while assessing material choices, product requirements and potential regulatory implications.

The issue remains under discussion as regulators and industry evaluate the safety, performance and availability of alternatives to fluoropolymer PFAS materials used in medical technology.

15-09-2026