Eurofins Medical Device Services North America, part of a global network of more than 20 medical device testing laboratories, has unveiled the first GMP PFAS testing and screening solution specifically for the medical device industry. 

 

The move positions Eurofins as a key partner for manufacturers navigating the increasingly complex global regulations surrounding PFAS, while supporting both patient safety and product compliance.

 

Per- and polyfluoroalkyl substances, or PFAS, are a group of over 20,000 chemical compounds known for their resistance to degradation and potential risks to human health and the environment. 

 

"Implementing PFAS testing in the early development stages allows medical device manufacturers to prepare for potential regulatory updates and avoid future shutdowns, recalls, and liability issues, while further supporting their sustainability goals," said a Eurofins spokesperson.

 

The new GMP PFAS testing and screening solution includes: combustion Ion chromatography (CIC) for total organic fluorine screening in solids, liquids, and gases, providing an initial assessment of PFAS levels, process mapping and supply chain audits to identify contamination pathways, solvent extraction and direct combustion for flexible sample formats, and extractables & leachables (E&L) testing, toxicological risk assessments, and aging studies.

 

The launch underscores the company’s commitment to helping medical device manufacturers stay ahead of evolving regulatory requirements while safeguarding patient health.