Per- and Polyfluoroalkyl Substances (PFAS), commonly known as "forever chemicals", feature extremely stable carbon-fluorine bonds, high bioaccumulation potential and suspected endocrine disrupting properties, leading to stringent regulatory restrictions worldwide. According to OECD statistics, the PFAS family comprises over 10,000 substances. Fluoropolymers including Polytetrafluoroethylene (PTFE), FEP, PFA, PVDF and PCTFE are widely applied in cardiovascular catheters, implant coatings, pacemaker wire insulation, as well as sterile high-barrier packaging for medical devices.

Although high-molecular-weight fluoropolymers have extremely low bioavailability, the US FDA has explicitly stated that such substances like PTFE and FEP cannot penetrate cell membranes, delivering high biological safety with no viable alternatives currently available, and thus their use shall be retained. In contrast, the EU is rolling out increasingly strict regulations. The proposed EU REACH restriction on PFAS makes no distinction between high and low molecular weight substances. Any chemical containing a perfluorinated carbon structure will be subject to restrictions. This one-size-fits-all approach has put medical device manufacturers relying on fluoropolymers under unprecedented compliance pressure.

I. European Union

EU POPs Regulation (EU) 2019/1021 and its amendments (EU) 2025/718, (EU) 2023/1608

PFOA, PFOS and PFHxS are fully prohibited from intentional manufacture, use, import and export. For articles, the residue limit for PFOA and its salts is ≤ 0.025 mg/kg (25 ppb); the limit for PFOA‑related compounds is ≤ 1 mg/kg (2 mg/kg allowed for non‑invasive medical devices). For PFOS and its salts, as well as PFHxS and its salts, the same strict limit of ≤ 0.025 mg/kg (25 ppb) applies, and the sum of PFOS‑related compounds and PFHxS‑related compounds shall not exceed 1 mg/kg.

REACH Regulation

Annex XVII entry 68 – C₉–C₁₄ PFCAs (perfluorocarboxylic acids) and their salts / related substances:

For articles: ≤ 25 ppb; sum of related substances ≤ 260 ppb. (The temporary exemption for invasive/implantable devices expired on 4 July 2025.)

SVHC list contains PFOA, PFDS, PFHxS, C₉–C₁₄ PFCAs, etc.

If concentration in a homogeneous material > 0.1% (w/w), SCIP notification and supply chain communication are required.

REACH PFAS universal restriction proposal (core risk)

The restriction proposal was submitted in January 2023 by five Member States (Germany, Netherlands, Denmark, Norway, Sweden). In March 2026, ECHA‑RAC adopted its final opinion supporting a broad restriction. SEAC’s draft opinion proposes a 13.5‑year derogation for implantable and invasive medical devices, the same 13.5‑year derogation for PCTFE‑based packaging, and a shorter derogation or no exemption for non‑invasive / non‑implantable devices. The regulation is expected to enter into force in 2027–2028, with the derogation period starting 18 months after the entry into force.

II. United States

1. FDA position (August 2025): Fluoropolymers such as PTFE are considered safe and currently irreplaceable for medical applications. Medical devices regulated by the FDA are not subject to PFAS bans, but companies are encouraged to reduce PFAS emissions during manufacturing.

2. TSCA Section 8(a)(7): Companies that manufactured or imported PFAS‑containing substances, mixtures or articles between 2011 and 2023 were required to submit PFAS usage data to EPA (already implemented). Failure to report may result in penalties.

3. State legislation: Colorado (SB 24‑081, effective 2028), Connecticut (SB 292, effective 2026), Minnesota (effective 2032), Maine (effective 2032), New Mexico (effective 2028), etc. – all explicitly exempt FDA‑regulated medical devices. However, most definitions do not differentiate between fluoropolymers, so future amendments may tighten requirements.

4. TPCH Model Legislation on Packaging: Adopted by most states – total fluorine (indicating PFAS) in packaging and packaging components ≤ 100 ppm (some states require “PFAS not detected”). Medical device outer packaging should be checked.

III. China

NMPA registration: Current medical device registration regulations do not have specific PFAS clauses. However, if a product contains restricted PFAS substances exceeding the POPs limits, it will not comply with the Essential Principles of Safety and Performance of Medical Devices and may face technical review risks. It is recommended to attach a compliance declaration for the fluoropolymer material and a residue test report in the registration dossier.

IV. Practical Impact and Risk Alerts for Medical Device Companies

1. Supply chain disruption may occur before the ban takes effect: 3M announced it will stop producing PFAS‑related products by the end of 2025. Other suppliers are also reducing their medical device product lines. Single‑source PTFE tubing / seals may face supply interruptions.

2. Bill of materials (BOM) traceability: Companies must request fluoropolymer PFAS residue reports or DoC (Declaration of Conformity) from upstream suppliers.

3. MDR / NMPA technical documentation: Add PFAS chemical hazard identification and compliance evidence to the ISO 14971 risk management file.

4. SCIP notification: For products placed on the EU market that contain SVHC‑PFAS at > 0.1% (w/w), SCIP notification is required.

5. Long‑term substitution pressure: Even if a derogation is granted (e.g. until approx. 2040 under EU rules), parallel validation of fluorine‑free / low‑fluorine alternative materials (modified silicone, DLC coatings, specialty TPU, etc.) should be initiated. Any change may trigger a significant change re‑assessment under MDR.

V. Services Offered by CIRS Testing

✅ PFAS restricted substance testing under POPs / REACH (PFOA, PFOS, PFHxS, C₉–C₁₄ PFCAs, detection limit at ppb level)

✅ REACH SVHC PFAS screening and SCIP notification agent

✅ Chemical compliance assessment (including PFAS risk analysis) for medical devices under MDR / NMPA

✅ Fluoropolymer material Declaration of Conformity (DoC) review and customised supply chain questionnaire

✅ Total fluorine screening (IC method) + targeted PFAS quantification (LC‑MS/MS)

If you require a customized PFAS compliance determination report for a specific product (e.g., PTFE catheter, implant, IVD consumable, PCTFE packaging), or a template letter to respond to customer or customs inquiries, please contact the CIRS Regulatory Compliance Service Team. At CIRS Testing, we help you navigate complex regulatory landscapes and ensure your products are safe and reliable. For any assistance or questions, feel free to reach out to us at test@cirs-group.com.