Yes, Medical Device Manufacturers Still Need to Focus on PFAS in 2025

Per- and poly-fluoroalkyl substances (PFAS) regulations dominated the headlines in 2023, following the publication of Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The finalized rule requires U.S. companies that use, manufacture, or import PFAS to submit substance use data, including importation, dating back to 2011.

The medical device industry felt some relief from these requirements through certain TSCA exclusions and reporting deadline extensions. However, manufacturers are not necessarily exempt from other PFAS-reporting regulations or immune from other risks.

Now that it’s 2025, the conversation has moved past “Is this going to affect us?” to more strategic, complicated questions: What substances exactly are we using? Will these materials be obsolete in two years? How do we stay ahead of what’s coming next?

Reporting vs. Restriction: Know the Difference

It’s helpful to categorize product substance regulations into two groups: restrictions that prohibit substance use (in this case, PFAS) and reporting rules that require companies to disclose product composition data.

So far, PFAS in medical devices have been exempt from restrictions but not always from reporting requirements. Since TSCA Section 8(a)(7) came into force, more regulations have been published:

In July 2024, Environment and Climate Change Canada (ECCC) issued a notice under the Canadian Environmental Protection Act (CEPA) requiring companies to report on the manufacture, import, or use of 312 PFAS chemicals during the 2023 calendar year by January 29, 2025. There was no medical device exemption. 

More than 20 U.S. states have enacted new PFAS laws, and 2025 will be no exception. While most laws target consumer goods such as textiles, food packaging, and cosmetics, the trend is focused on broader supply chain transparency. Many laws require manufacturers to report where PFAS are used in products, regardless of medical device exemptions for use restrictions.

In the EU, regulators have already targeted specific PFAS through multiple regulations such as the Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation; the Persistent Organic Pollutants (POPs) Regulation; the Drinking Water Directive; and more. Products found to contain PFAS that are on the substances of very high concern (SVHC) list are also required to be submitted to the Substances of Concern In articles, as such or in complex objects (Products) (SCIP) database if they exceed the allowed threshold.

The European Chemicals Agency (ECHA) is also working through a proposal for a broad “Universal PFAS Ban” under REACH. ECHA is exploring options to full bans for certain sectors, such as medical devices, as part of an ongoing conversation with the industry. But for companies to participate in those conversations and secure those exemptions, they need to understand which PFAS they’re using and for what purposes and be able to justify their uses as essential.

And while medical devices are outside the reach of TSCA because they are regulated by the U.S. Food and Drug Administration (FDA), that doesn’t mean everything a medical device manufacturer uses is exempt from the EPA’s PFAS reporting requirements. Manufacturers may still have to report on non-FDA-regulated products or materials that were imported to be used in their equipment or processes rather than in medical devices themselves.

PFAS Obsolescence: Businesses Starting to Feel the Impact

In late 2022, 3M announced its decision to exit PFAS manufacturing by the end of 2025, which sent shockwaves through the medical device industry. Assent has collected and analyzed over 3 million PFAS declarations from manufacturers across global supply chains. According to the data, 75% of all PFAS declarations we’ve processed reference substances included in products that 3M is phasing out.

3M is not alone. Other chemical manufacturers are quietly scaling back or discontinuing PFAS production to reduce risk exposure and avoid litigation. Medical device manufacturers won’t be able to simply replace 3M with a different vendor to avoid disruptions. Shortages of critical components could trigger the need for product redesign and recertification, even if medical device exemptions are allowed in the PFAS restrictions themselves. PFAS will drive redesign and early obsolescence in a way equipment manufacturers haven’t seen since EU RoHS 2 was published in 2011.

The operational impact can also be significant. Manufacturers face increasing disruption risks to their maintenance, repair, and operational (MRO) processes. PFAS-based components like gaskets, seals, O-rings, and coatings have become more challenging to source and more expensive, often requiring last-time buys or unplanned redesigns. When PFAS are essential to electroplating, manufacturers may also need to replace or reconfigure equipment entirely. These changes introduce unexpected capital expenses and can impact production schedules, operational budgets, and long-term planning.

At a recent National Safety Council Forum meeting, one presenter shared that after transitioning to PFAS-free alternatives in their factory, a component previously replaced every two years now needs to be replaced every three months, resulting in eight times the production downtime. Others have had to renegotiate service agreements, adjust warranty terms, or build up parts inventories to avoid future shortages.

Just because a company is allowed to use a type of PFAS doesn’t mean it will be able to get them. To avoid disruption, companies need visibility into everything they source to manage obsolescence risk. This visibility includes parts used to run their factories, not just what goes into their final product.

Looking Forward: The Future of Fluoropolymers

PFAS are so ingrained in the medical device industry that a federal study out of Belgium suggests that over 90% of medical devices contain at least one PFAS substance.

These substances are used in everything from low-friction coatings on catheters, tubing, and stents to seals, gaskets, electronic parts, paints, and packaging. Their properties make them indispensable in highly specialized applications across medical imaging, cardiac care, ophthalmology, and general surgical supplies. This widespread use helps explain why PFAS regulation is so uniquely challenging for the medical device sector. These substances aren’t just additives — they’re engineered into the core of critical device functions.

Our research shows that while thousands of PFAS compounds exist, fewer than 500 are actively used in commerce. Only 10 account for 70% of the total volume reported. The most common in medical devices is PTFE (polytetrafluoroethylene), more commonly known by the trade name Teflon. It’s a fluoropolymer prized for its durability and biocompatibility.

The regulation of fluoropolymers like PTFE is currently under debate in Canada and the EU. While Canada has included fluoropolymers like PTFE in its one-time reporting requirements, its PFAS Management Plan indicated that they will be considered in a separate assessment based on current evidence of risk compared to other PFAS. Similarly, EU regulators are considering whether these substances should be subject to the same restrictions as other PFAS. If exempted, this could offer relief for medical device manufacturers if they can still obtain the necessary materials. Manufacturers seeking these exclusions must be prepared to demonstrate their essential uses to regulators.

2025: The Era of PFAS Transparency

PFAS regulations will continue to evolve. Getting to this moment in the regulatory timeline has already been a complicated mix of legal, governmental, corporate, and public pressures. However, as regulators collect more data through mandatory reporting, companies should expect to see more nuance and complexity in their requirements. Right now, supply chain data is king.

That’s why it’s crucial that medical device manufacturers be engaged and active participants in the regulatory cycle. The PTFE situation is just one example of how regulators are working with the industry to carve out currently unavoidable use (CUU) exemptions. But to grant exemptions, regulators need to understand which specific substances are used for what applications. Arguments about costs or the possibility of disruption won’t persuade regulators. Instead, carveouts are earned by manufacturers coming prepared with product-level data. That means:

• Engaging with suppliers to collect in-depth PFAS data, including specific CAS numbers and concentrations
• Understanding exactly which PFAS are being used in each product and where essential or CUU exemptions may be needed
• Identifying parts obsolescence risks by partnering with suppliers to understand their strategies
• Monitoring proposed PFAS regulations at the U.S. state level and globally
• Joining industry groups for advocacy efforts to educate regulators

The exemptions that give medical device manufacturers relief from some PFAS restrictions should not be an excuse to ignore the business risks that the use of PFAS creates. This includes pressures or potential litigation from insurers and investors not just for products, but also for environmental contamination caused by past and current operations.

Exemptions don’t protect companies from the most significant risk of all: parts obsolescence and costly supply chain disruptions. This is why accurate supply chain data is so important. It helps manufacturers identify where PFAS are being used so they can plan to address their risk and keep their products moving. 

Cally Edgren has over 30 years of experience shaping the landscape of regulatory practices at companies like Rockwell Automation and Kohler Co. Currently, as the VP, Regulatory & Sustainability at Assent, she leads initiatives on materials compliance and PFAS management, helping manufacturers create safe, compliant products and engage their supply chains for compliance data. For information on the Assent Sustainability Platform, which delivers rapid access to supply chain data, visit Assent’s website.