Materials
than 2029–30. Whether certain products will be subject to temporary exemptions (for instance, if no PFAS-free alternative can be identified) is still being decided. Special consideration may be given to certain types and/or uses of PFAS, such as fluoropolymers in medical devices.
Things are less concrete in the UK. In February 2026, the government published a plan for managing the risks of PFAS but has yet to commit to implementing restrictions. However, Thakker predicts that the UK will eventually try to align with Europe. So, in terms of regulatory burden, what could the transition away from PFAS look like? Manufacturers would need to inform their notified body of any significant changes to a device. This includes changes to the intended purpose or design that could affect safety or performance, such as removing a PFAS component or replacing it with something else. Reviews may be required for substantial changes: companies would need to demonstrate that their devices are safe and perform to the required standard. Any alterations to the manufacturing process that don’t change the device will be picked up at a yearly review, Thakker adds. If a complete redesign is needed, a full resubmission may be required. This could add months, or potentially years, to development times. To comply with PFAS restrictions, companies in the EU would need to submit information about the properties of chemical substances within their devices to the European Chemicals Agency (ECHA). So, it’s
best to plan, Thakker advises. Contact your notified body beforehand and let them know about possible changes you have in the works. “You don’t want to come to a stage where you’ve implemented the change, you go to the notified body and they say they can’t review it for six months. And then you can’t place the devices on the market.”
A PFAS-free future?
Even with restrictions in place, we may not see a total ban on PFAS use in medical devices. “There may be some applications where we will just never find alternatives, because of [fluoropolymers’] special properties,” says Cousins. He continues: “I don’t think we’re going to come to a fluoropolymer-free future, even in the next couple of decades, because of their special properties. But hopefully what we will do is work out where they are essential, and just only use them where we really need their properties.”
Achieving this is more than just an engineering or chemical problem (it’s a policy issue, too). Clear, decisive guidance from governments and regulators will allow manufacturers to make concrete plans about how they’ll move forward. It may also incentivise innovation in developing PFAS alternatives. “There are already alternative materials on the market for certain applications,” says Cousins. “So that makes me feel like we can make a change, where there’s a will.” ●
COMPAMED in Düsseldorf 16-19 November 2026 Hall 8a Stand G16
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