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

Fallouh Healthcare Receives Grant Funding From Innovate UK

 

Fallouh Healthcare has received £305,050 in grant funding from Innovate UK as part of the European Union’s Eureka Eurostars program. The company aims to detect cardiac tamponade, a condition that affects patients after heart surgery. Currently, there is no way to accurately diagnose the condition.

UK Trails NHS 10-Year Plan With Launch Imminent

 
• By 

Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.

New EU Rules Limit Chinese Participation In Medtech Procurement

 

From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.

FDA Regulations ‘Lock Out’ Clinically Proven Neuromodulation Devices

 

Flow Neuroscience's neuromodulation headset for the treatment of depression is approved and marketed in the EU. However, two years on, the company is still waiting for US FDA approval despite being assigned breakthrough device designation.

More from Geography

Mexico’s New Procurement Rules Aim To Increase Healthcare Investment, But May Face Legal Trouble

 

Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.

Newborn Screening Tests Among FDA Classifications

 
• By 

The US FDA has announced classifications for five device types, including four diagnostics as well as a hand cream to protect healthcare workers exposed to radiation. Two of the products are newborn screening tests.

Will Kennedy And Makary Come To Terms On User Fees During Next Round Of MDUFA Negotiations?

 

It’s no secret that Marty Makary and Robert F. Kennedy Jr. have a different take on user fees, with Makary viewing them as a funding necessity and Kennedy as a corrupting influence. But will they find a way to strike a balance during the next MDUFA reauthorization talks so each can claim victory?