Derogations are assessed per use, not per sector
Within a single product, one PFAS use may be covered by a derogation while another is not. Being a medical device manufacturer does not exempt an entire product range.
PFAS regulation needs a
replacement, not an explanation
- 10,000+
- General ban + use-specific derogations
- 18 months after entry into force
- 6.5 or 13.5 years
Fluoropolymers are the hardest material in a catheter to replace, and most of the industry stops at explaining what PFAS is. The principal actually supplies a UHMWPE liner that replaces the PTFE one — so this page ends with a swap route rather than an explanation.
Derogations are not granted by sector
Misreading this structure means missing the moment to act. What the unit of assessment is, is everything.
It is a general ban with time-limited, use-specific derogations
There is an 18-month transition after entry into force, and five- or twelve-year derogations are under discussion for medical uses — 6.5 or 13.5 years including the transition.
Any derogation starts from having identified the use
Uses not identified during the consultation risk falling outside the derogation. The deeper the supply chain, the longer identifying those uses takes.
It applies to exported products and to component supply chains
The EU rules do not apply directly to sales inside Korea. They do apply to finished devices exported to the EU, and to components supplied by Korean firms to EU customers. The real decision is whether to separate domestic and export designs or build to the stricter standard from the start.
A UHMWPE liner is actually supplied
The principal supplies a UHMWPE liner that replaces the PTFE one. The sample specification is 3.41 mm ID × 0.03 mm wall, stacked as UHMWPE + 304SS + TPU. This is one sample specification, not a production range — that is confirmed by consultation.
The principal states wear resistance is better than PTFE
No test conditions are stated, however. Trackability, friction and bonding behaviour cannot be read from a specification sheet, so a physical sample evaluation is required. What is confirmed is that the plasma-etching step PTFE required drops out.
Where it stands
2023-01
Five member states submit the restriction proposal to ECHA
Germany, the Netherlands, Denmark, Sweden and Norway filed a joint REACH-based PFAS restriction covering more than ten thousand individual substances.
2023-02
ECHA publishes the proposal
The proposal — a broad ban on manufacture, placing on the market and use — went to public consultation and drew over 5,600 comments.
2026-03-02
RAC adopts its final opinion
The Committee for Risk Assessment finalised its view on whether the restriction is appropriate for reducing risk to health and the environment.
H2 2026
SEAC final opinion expected
Covers the availability of alternatives and the socio-economic impact. The draft considered derogations for implantable and invasive devices justified.
2027
Adoption outlook
On the current timetable, adoption is discussed for 2027, followed by an 18-month transition period after entry into force.
Which materials are in scope
PTFE
FEP
PFA
UHMWPE
PEEK
PI
PEBAX
TPU
PA
PE
PTFE liner → UHMWPE liner
| Property | Current — PTFE, etched | Replacement — UHMWPE |
|---|---|---|
| In PFAS scope | In scope | None |
| Sample ID | 3.45 mm | 3.41 mm |
| Sample wall | 0.04 mm | 0.03 mm |
| Colour | — | Clear · white |
| Layer stack | PTFE + 304SS + TPU | UHMWPE + 304SS + TPU |
| Wear resistance | — | Better than PTFE — principal’s wording, test conditions not stated |
| Surface treatment | Plasma etching required | — |
There is no reason to wait for adoption
Build the PFAS list per use
Record it as “which function of which component”, not as a material name — because the unit of assessment is the use.
Start with the liner
The PTFE liner is where PFAS content is highest in a catheter — and it is also where a replacement has been demonstrated.
Evaluate the replacement physically
A specification sheet cannot tell you trackability, friction or bonding behaviour. Pushing a sample through is the only way.
Document the uses that cannot be replaced
The reasons replacement is not possible, and the steps taken to minimise emissions, are what the derogation discussion runs on. Without records there is no case.
The timetable differs for uses that have a replacement and uses that do not
That derogations are assessed per use is what matters most in practice. Within one catheter the PTFE in the liner may be replaceable while the coating at a joint is not, and the two uses are assessed separately. "Our product is a medical device" is therefore not a plan. Building the list per component — more precisely, per function — comes first.
Uses with a replacement and uses without diverge. Where a replacement exists the case for derogation weakens, so those uses should move first; where none exists, accumulating evidence for the derogation discussion is the realistic path. Liners likely fall into the first group, because a replacement is already being supplied.
For Korean companies there is one more layer. EU rules do not apply directly to domestic sales, but they do apply to exported products and to component supply chains. Whether to separate domestic and export designs, or to build to the stricter standard from the start, is the real decision. We do not make that call for you — we supply the materials and documentation both routes need.
Starting with the liner is the fastest route
Give the ID, wall and length of the PTFE liner you use now and we come back with a UHMWPE replacement sample. Where a use cannot be replaced, we help assemble the evidence.