NEW YORK – Swiss diagnostics company AliveDx, formerly Quotient, said Monday that it gained IVDR certification for its in vitro diagnostics manufacturing sites in Eysins, Switzerland, and Edinburgh, UK.
The firm said the facilities received certification through EN ISO 13485:2016 resulting in both sites meeting the European Union's In Vitro Diagnostic Regulation requirements to continue sales of diagnostic solutions after the transition away from the rules established under 1998's IVD Directive. The firm said the certification reinforces its commitment to quality across its Alba transfusion portfolio and its automated MosaiQ multiplex and multimodal diagnostics platform.
"It reinforces our unwavering commitment to partner with our customers in providing high-quality in vitro diagnostic solutions," AliveDx CEO Manuel Méndez said in a statement. "We are dedicated to upholding the highest standards of quality, safety, and compliance."
AliveDx also received CE markings last month for a pair of multiplexed microarray immunoassays used to aid diagnosis of connective tissue diseases.
Diagnostics firms in Europe have been working through more stringent certification and regulatory processes during the transition to IVDR. Though firms were originally asked to become compliant by May 2022, EU legislators have implemented risk-based grace periods for the transition.