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First IVDR certification for Roche Diagnostics

17.12.2020

  • 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.

 

About IVDR

 

The In-Vitro Diagnostic Medical Devices Regulation (IVDR) will replace the existing In-Vitro Diagnostic Medical Devices Directive (IVDD). The IVDR was published in May 2017,  marking the start of a five-year period of transition from the IVDD. 

For further information, please visit: EUR-Lex

 

About Roche

 

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

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