Plastics extrusion and materials specialist Zeus Industrial Products Inc. has introduced what it claims is the first polyimide tubing compliant with REACH and the European Union’s Medical Device Regulation (MDR). The PI and PI Glide products, which were tested by an independent lab, are now available to the global market.
"We understand our customers face regulatory burdens and we are committed to helping them overcome these challenges,” commented Bob Chaney, Senior Vice President, Global Sales & Marketing. “Without a compliant [polyimide] supplier, companies may have to evaluate other materials or shelve plans to distribute products in Europe. Our compliant polyimide products not only provide peace of mind but can potentially save hundreds of thousands of dollars by avoiding material re-evaluation, product re-designs, and launch delays,” said Chaney.
An acronym for Registration, Evaluation, Authorization and Restriction of Chemicals, REACH restricts the sourcing of harmful materials into the European Union (EU), explained Zeus in its announcement. REACH requires all companies to manage risks linked to the substances they manufacture and market in the EU.
The MDR ensures high standards of quality and safety for medical devices produced in or supplied into Europe. While REACH focuses on material composition, the more encompassing EU MDR regulation is specific to medical devices, added Zeus.
"Through continuous refinement and improvement of our manufacturing processes, Zeus is now able to provide REACH and EU MDR compliant polyimide tubing,” said Matt Allen, Senior Product Manager. “We are the only supplier globally that can do this, and achieving this compliance did not alter our end product in any way. Through extensive lab testing, Zeus has confirmed the chemical structure and mechanical properties of the polyimide tubing products remain unaffected."
High-performing polymers known for their chemical, thermal, and mechanical properties, polyimides are used extensively in medical applications, especially in the construction of vascular and non-vascular catheters. Zeus offers a range of polyimide tubing products customizable in size, thickness, color, and level of lubricity.