This move ensures that clinical laboratories using Devyser CFTR tests can operate with enhanced regulatory certainty, trusted conformity, and alignment with the latest European standards. This regulatory upgrade builds on Devyser’s earlier successes in securing IVDR designation across its broader product range, including RHD (Class D) and post-transplant monitoring solutions.

“Achieving full IVDR compliance for our CFTR NGS portfolio is a major milestone in our mission to deliver diagnostics of the highest standard,” said Olle Myrberg, VP QA/RA, Devyser. “It demonstrates our regulatory maturity and our deep dedication to product performance and patient safety.”

What this means for users and stakeholders
With IVDR compliance, Devyser’s CFTR assays now adhere to a robust set of requirements around analytical performance, clinical evidence, scientific validity, and ongoing post-market surveillance. For clinicians, genetic counselors, and patients, this regulatory step reinforces the reliability and traceability of test results and fosters greater confidence in diagnostics supporting patient analysis as well as cystic fibrosis screening, carrier testing, and therapeutic decision-making.

Devyser supports its users all the way through the transition to IVDR ensuring a seamless implementation “This IVDR approval represents not only regulatory excellence but also a clear advantage for our laboratory partners,” said Jan Wahlström, CEO, Devyser. “With CFTR now IVDR-certified, labs can continue to offer high-quality cystic fibrosis testing with full confidence, while patients benefit from the reliability and speed that define Devyser’s genetic testing solutions. It reinforces our leadership in bringing clinically proven, market-ready diagnostics to customers across Europe.”

About Devyser CFTR
Devyser CFTR is an NGS-based assay designed for comprehensive analysis of the CFTR gene, providing clinicians and laboratories with a complete genetic picture of each patient.