- Roche is the first manufacturer to receive an “EU Quality Management System Certificate (IVDR)” for more than 700 catalogue numbers of the Serum Work Area and Lab Coagulation portfolio
- Certification is mandatory for products to be CE-marked under IVDR
- Roche Diagnostics is on track to fully comply with In Vitro Diagnostic Medical Devices Regulation (IVDR)
Basel, 17 December 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 Diagnostic Medical Devices Regulation (IVDR). The certification applies to more than 700 catalogue numbers of the Serum Work Area and Lab Coagulation product 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.
Roche is actively managing this important transition to ensure its vital products will be available to healthcare professionals and patients at all times. As Roche has several different Quality Management Systems and different notified bodies, further audits and technical file submissions are planned before the entire portfolio will be certified.
Roche Diagnostics fully supports the new In Vitro Diagnostics Medical Devices Regulation (IVDR 2017/746) as it aims to ensure a smooth functioning of the EU market based on a high level of health protection for patients and users.