On 17 December, Roche announced that it has received its first “EU Quality Management System Certificate (IVDR)” from TÜV SÜD Product Service, one of its notified bodies under the new In Vitro Diagnostics Regulation (IVDR). The certification applies to more than 700 catalogue numbers of the Serum Work Area and Lab Coagulation portfolio.
This “EU Quality Management System Certificate (IVDR)” is mandatory for any manufacturer of in vitro diagnostic devices (IVDs) to issue declarations of conformity for their products and to get them (re-)certified in compliance with the new regulation.
Our path to IVDR compliance
We are committed to managing the important transition from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR) actively and in a timely manner. Meeting the regulatory requirements and our customers’ needs to ensure availability of our vital products to healthcare professionals and patients are our priorities. To achieve full IVDR compliance we are following a multi-stage approach: