PFAS-Free Coating for Medical Devices
The EU is moving to restrict PFAS, including fluoropolymers such as PTFE that are used for low friction on catheters and other medical devices. This page explains what is changing, what to do now and how PFAS-free coating options compare, including LipoCoat®.
What the EU PFAS restriction means for medical devices
What to do now, step by step
How LipoCoat® compares with PTFE, PVP and silicone
Where LipoCoat platform technology fit best
Why PFAS are under review in Europe
PFAS are a large family of man-made chemicals, valued for their stability. That same stability lets them persist in water, soil and the human body. The European Environment Agency (EEA) found that a substance-by-substance approach is not adequate for a group this large, so regulators now look at PFAS as a group. This background explains what that means for medical device coatings.
The reason why PFAS persist
All PFAS chemicals are built around a stable fluorine-carbon bond. Fluorine is the most electronegative element, and its bond with carbon is the strongest single bond in organic chemistry. Heat, chemicals and living organisms barely affect it. That bond gives them unique properties, such as water and oil repellence, heat resistance and chemical resistance, and it also stops them from breaking down. And this last part is the main problem. Because they last, PFAS build up. They accumulate in people, animals and the environment.
What the evidence shows
Of the relatively few PFAS that have been studied well, most are considered moderately to highly toxic. Effects with high certainty include thyroid disease, raised cholesterol, liver damage, lower birth weight and a weaker response to vaccines. In 2018 the European Food Safety Authority lowered its provisional safe limits for two well-studied PFAS, PFOS and PFOA, and concluded that a considerable share of Europeans is expected to exceed them through food and drinking water.
Why regulators look at the whole group
PFAS reach people and the environment through production sites, firefighting foam, textiles and waste streams, and the EEA estimates that around 100,000 sites in Europe may emit them. When individual PFAS were restricted, many were replaced by short-chain and polymeric PFAS, several of which are persistent too. With thousands of substances, testing them one by one takes too long. In 2019 the Council of Ministers called for an action plan to eliminate all non-essential uses, and that group approach now shapes the restriction.
EU PFAS restriction: what it means for medical device coatings
The EU is working on a broad restriction of PFAS under REACH, covering more than 10,000 substances. Fluoropolymers such as PTFE, FEP and PFA fall under the proposal, and they are used in catheters and other medical devices for their low friction. Whether medical devices will receive derogations is not final. This timeline shows where the process stands and what you can do while it runs. LipoCoat® is a PFAS-free, bio-inspired coating that helps you prepare your portfolio.
Five countries propose a joint PFAS restriction
In 2023, five European countries (the Netherlands, Germany, Denmark, Sweden and Norway) put forward a joint proposal to restrict PFAS across the EU and EEA. The EU was still weighing a full PFAS ban, yet it made an important move by launching the process for a broad restriction under REACH.
From proposal to detailed assessment
Between 2023 and 2026, the proposal moved into detailed assessment by the scientific committees of the European Chemicals Agency (ECHA). The Risk Assessment Committee (RAC) adopted its final opinion on 2 March 2026. The consultation on the draft opinion of the Socio-economic Analysis Committee (SEAC) closed on 25 May 2026, and its final opinion is expected at the end of 2026. No final restriction has been adopted yet, so manufacturers can still prepare: map where PFAS are used, investigate alternatives and plan validation.
Decision and transition period
From 2027, the European Commission may prepare the draft restriction text under REACH Annex XVII. In 2027–2028, the text could be discussed and voted on by the REACH Committee, and around 2028–2029 the restriction could be adopted, depending on the legal process. Whether medical devices receive derogations is still open. NAMSA describes two options, a ban with an 18-month transition or a ban with time-limited derogations of 5 or 12 years, and estimates that the effect on devices comes no earlier than 2029–2030.
Preparing PFAS alternatives
Companies that wait for the final legal text may lose valuable time. By 2029, you should already know where PFAS are used in your portfolio, which applications are critical and which alternatives are realistic. Starting early gives you room for testing, design changes and early conversations with your Notified Body.
What medical device manufacturers should do now
The final text is still open, and preparation takes time. These seven steps help you get ready, starting with an inventory of where PFAS are used in your portfolio.
Map PFAS exposure
List every device, component and process that uses PFAS, including fluoropolymer coatings such as PTFE, FEP and PFA, and ask your suppliers for composition data.
Prioritize high-risk applications
Rank applications by clinical criticality, regulatory exposure and how hard they are to replace, so your effort goes where it matters first.
Investigate alternatives early
Compare PFAS-free options per application, such as hydrophilic PVP coatings, silicone lubricants and LipoCoat®, and shortlist what fits your device and substrate.
Build a transition roadmap
Set milestones for testing, design changes, documentation and launch that run ahead of the expected adoption window around 2028–2029.
Test and validate alternatives
Run feasibility and performance tests on your own devices and substrates, including friction, durability and particulate behavior, and document the results.
Plan design and process changes
Check how a coating change affects your design files, manufacturing steps and risk management. A coating change can count as a substantial change under the MDR, so plan the documentation early.
LipoCoat versus PTFE, PVP and silicone
Sources:
Antifouling defense
Compared to uncoated control samples, LipoCoat®-treated surfaces sustained near-complete inhibition of biofilm formation for up to 29 days under continuous exposure. Full method available on request
Bio-Inspired medical coating technology
LipoCoat works purely as a passive physical/chemical barrier to prevent pathogen and protein fouling, eliminating the risks of chemical toxicity or antimicrobial resistance.
A platform technology powered by biological intelligence
LipoCoat® technology is engineered to mimic the human cell membrane. By combining cell biology with nanotechnology, we developed a coating that is free of PFAS, silicones and active pharmaceutical ingredients. LipoCoat® technology generates a thin hydration layer on your medical device, working as a shield that reduces pathogen and protein adhesion.
Interested in enhancing your portfolio with our platform technology? Compare our mechanical and biological properties with existing industry standards by downloading this comparison table.
A medical coating that is suitable for various clinical applications
Tailored to your specific application
Whether you need a thinner, smoother finish, or enhanced wettability and lubricity, we understand that every application has unique requirements. Thanks to the LipoCoat® platform technology, we can tailor our coatings to your exact specifications without altering the device's underlying mechanical properties or dimensions.
Easy to integrate
In your production process
LipoCoat® can be integrated on top of your existing product portfolio without the lengthy pharmaceutical classification processes. Furthermore, the coating requires no specialized handling, utilization, or disposal protocols, facilitating seamless integration into existing manufacturing workflows.
Documented for your submission
Full ISO 10993-1 programme passed, with test reports available for your technical file
Low barrier to entry
No curing or complex equipment required
FAST dip-coating process
Compatible with standard dip coating at room temperature.
Low material usage
Minimal material consumption during application.
FAQ
Answers on the EU PFAS restriction, PFAS-free alternatives to PTFE and how LipoCoat® fits.
In 2023, five European countries proposed restricting PFAS, a group of more than 10,000 substances, under REACH. Fluoropolymers such as PTFE are used in catheters, guidewires and other devices for their low friction. The assessment is still running: the Risk Assessment Committee (RAC) adopted its final opinion in March 2026, and the Socio-economic Analysis Committee (SEAC) is expected to finalize its opinion at the end of 2026. Medical devices are assessed separately within the procedure.
No exemption for medical devices has been confirmed as of October 2026. The proposal contemplates time-limited derogations for uses without suitable alternatives, potentially up to 12 years, and the European Commission has named healthcare as an area where continued PFAS use may be justified. No date is set: after SEAC finalizes its opinion, the Commission drafts an amendment to REACH Annex XVII, which Member States, the European Parliament and the Council then review. Estimates point to adoption around 2028–2029, and NAMSA expects the effect on devices no earlier than 2029–2030. A coating change can count as a substantial change under the MDR and, in the US, may trigger a 510(k) review, so testing and documentation need lead time.
Common options are hydrophilic coatings such as PVP, silicone lubricants and bio-inspired coatings such as LipoCoat®. PVP gives wet lubricity for catheters and guidewires, but coatings can swell and separate on intravascular devices, so integrity testing matters. Silicone is established for needles and syringes, but oil can migrate into the drug product. See the comparison cards above for the trade-offs.
It depends on what the PTFE does on your device. Where you need wet lubricity and reduced protein, platelet and bacterial adhesion, such as on catheters, needles and contact lenses, LipoCoat® is a PFAS-free option to evaluate. It is free of PFAS, silicones, active pharmaceutical ingredients and animal-derived components, and it is a passive coating that does not leach active substances. Where you rely on dry, very low friction or high chemical and heat resistance, PTFE is hard to match, and we will say so in a feasibility study.
We start from your device, substrate and performance goals and apply LipoCoat® by dip coating under mild conditions. Particulate behavior and dimensional impact are verified on your device and substrate. Compatible materials include polyurethane, PVC, silicone, PEBAX, PEEK, nylon, hydrogels, RGP contact lens materials and metallic or ceramic components. Test reports are available for your technical file.
The nanoscale structure is a major engineering advantage. The coating attracts water molecules to form a dense, stable hydration layer. Because LipoCoat® is bound at the molecular level rather than applied as a thick, brittle polymer film, it is designed to minimize delamination, cracking and particulate generation (flaking), a common point of failure flagged in FDA safety alerts for traditional lubricious coatings. Particulate behavior is verified for your device and substrate during testing, and durability is tuned through coating composition and layer thickness.
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