EU’s Historic PFAS Restriction Looms Over Medical Devices Sector

The European Chemicals Agency’s committees for Risk Assessment (RAC) and Socio-Economic Analysis (SEAC) are evaluating sector by sector the proposed REACH restriction on PFAS and more than 5,600 public comments, reaching provisional conclusions on cosmetics at their June meetings. A date has not been set to consider PFAS uses in medical devices, which are numerous, essential, and in many cases devoid of alternatives, industry says.

• Source: Shutterstock (Shutterstock)

The European Union’s proposed restriction on per- and polyfluoralkyl substances (PFAS) could eliminate medical devices required for minimally invasive surgeries, among many others, to the detriment of millions of patients, according to MedTech Europe.

MedTech Europe’s views were among more than 5,600 comments submitted by 25 September 2023 to the European Chemicals Agency...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Europe

US Puts 15% Tariff On EU Exports But Medtechs Push ‘Zero For Zero’

 
• By 

The US’ foreign trading partners are not working hard enough to secure bilateral deals, says US President Donald Trump, who will introduce new reciprocal tariffs on Aug. 7. MedTech Europe stresses that patients will suffer if medtech is not excluded from the tariffs.

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

Why EU Notified Bodies Need To Alter The Way They Work

 

Without change, the implementation of the MDR and IVDR could hit another wall.

UK MHRA Takes Stock, Seeks CMSO And Reveals Device Innovation Early Access Thinking

 
• By 

Evolution of the MHRA and its offering to medtechs continues, with the hunt for a visionary chief medical and scientific officer and release of outline plans on early access to innovative devices, building on IDAP learnings.

More from Geography

Ultromics Wins $55M, The Key To Success: Diagnosing Diseases With Available Treatment

 

Ultromics has secured $55m in Series C funding to advance its AI tool, EchoGo, which detects undiagnosed heart failure. The company's focus on diseases with available treatments resonated with investors.

MDUFA VI Talks Begin with Familiar Priorities: Innovation, Transparency, Safety

 
• By 

At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved transparency, streamlined reviews, enhanced safety measures, and greater patient involvement.

Global Medtech Guidance Tracker: July 2025

 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.