Overview

The Euro­pean Chem­i­cal Agency’s com­mit­tees for Risk Assess­ment (RAC) and Socio-Eco­nom­ic Analy­sis (SEAC) are cur­rent­ly eval­u­at­ing the pro­posed REACH restric­tion on per- and poly­flu­o­roalkyl sub­stances (PFAS), which has received over 5,600 pub­lic com­ments. While pro­vi­sion­al con­clu­sions on cos­met­ics were reached in June, no deci­sion has yet been made on med­ical devices.

The EU’s pro­posed PFAS restric­tion has raised con­cerns that it could impact med­ical devices used in cru­cial areas like min­i­mal­ly inva­sive surg­eries. The ini­tia­tive cov­ers over 10,000 sub­stances with car­bon-flu­o­rine bonds, known for their resis­tance to degra­da­tion.

Con­cerns about the blan­ket ban on PFAS 

One of the key con­cerns is that med­ical devices using PFAS have no alter­na­tives.

Crit­ics argue that the pro­posed blan­ket ban fails to account for the vary­ing prop­er­ties of dif­fer­ent PFAS. One of the key con­cerns is that med­ical devices using PFAS have no alter­na­tives due to their unique com­bi­na­tion of prop­er­ties such as chem­i­cal resis­tance, heat resis­tance, dura­bil­i­ty, etc.

These prop­er­ties are crit­i­cal for pre­ci­sion and reli­a­bil­i­ty in med­ical appli­ca­tions includ­ing implants, sur­gi­cal tools, diag­nos­tic tests, inhalers and con­tact lenses.

The med­ical device indus­try is alarmed by the pro­posed ban, stat­ing that it could end the pro­duc­tion of many med­ical devices and halt med­i­cine man­u­fac­tur­ing with­in three years. There are also poten­tial unin­tend­ed envi­ron­men­tal con­se­quences, as PFAS use is linked to reduced green­house gas emis­sions and improved ener­gy efficiency.

EU pro­pos­als for PFAS restrictions 

The EU has pro­posed two options:

  1. Com­plete ban of PFAS above thresh­old lev­els after an 18-month tran­si­tion peri­od.
  2. Com­plete ban with exemp­tions or phase-ins for select­ed PFAS cat­e­gories, with a tran­si­tion peri­od of five or 12 years fol­low­ing the ini­tial 18 months.

Trade orga­ni­za­tion MedTech Europe sup­ports the sec­ond option, advo­cat­ing for a patient-cen­tric approach that pro­vides real­is­tic tran­si­tion path­ways to non-PFAS alter­na­tives and dif­fer­en­ti­a­tion between high- and low-risk PFAS. MedTech Europe also calls for an R&D frame­work that aids man­u­fac­tur­ers in find­ing use-spe­cif­ic alter­na­tives to PFAS. These alter­na­tives must meet reg­u­la­to­ry require­ments of the med­ical devices reg­u­la­tion (MDR) and in vit­ro diag­nos­tic med­ical devices reg­u­la­tion (IVDR) while ensur­ing patient safe­ty.

Next steps

Stake­hold­ers will have 60 days to pro­vide feed­back on the SEAC draft opin­ion. After com­ple­tion of the feed­back peri­od, the com­mit­tee will final­ize its opin­ion, which will then move to the Euro­pean Com­mis­sion. The final deci­sion will be made via a comi­tol­ogy pro­ce­dure involv­ing Mem­ber States and the Euro­pean Par­lia­ment.

Source: Medtech Insight (an Infor­ma product)

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website