[Image courtesy of Confluent Medical]
Confluent Medical Technologies announced today that it now offers REACH and EU MDR-compliant polyimide tubing.
REACH, a European Union regulation, imposes stringent limitations for the EU market. It covers the amount of restricted substances contained in devices sold in the EU. It stands for Registration, Evaluation, Authorization, and Restriction of Chemicals. The industry-standard polyimide contains one of the restricted solvents. Common uses for polyimide include medical applications such as vascular catheters.
Confluent Medical said its REACH-compliant material uses industry-standard chemistry. It results in a product that looks and performs like traditional polyimide. However, it avoid the historical hurdles that need clearing to ensure EU compliance.
The company said it plans to offer the REACH-compliant polyimide immediately with lead times of four weeks or less.
“Historically, ensuring REACH compliance required extensive post-processing to remove the residual solvent and even after this processing, compliance is not guaranteed,” stated Jill Ellison, VP of site operations for Confluent’s Polymer Tubing Center of Excellence. “Confluent’s REACH-compliant polyimide is made with no restricted substances, therefore, there are no restricted solvents to remove and no extensive and expensive testing is required.”