Roche Receives CE Mark Certifications
Approvals also include CE Marking for the new HIV and HBV Assays Used on Company's Real-Time PCR Instrument, the COBAS TaqMan 48 Analyzer
Roche Diagnostics has announced the receipt of CE Mark certifications for all of its IVD (in vitro diagnostics) products currently marketed in the European Union (EU). The newly "CE Marked" tests are all products of original research from the Company's business area responsible for the development and manufacture of PCR-based products and services, Roche Molecular Systems, Inc. (RMS).
Obtaining rapid and timely CE Mark approval for its IVD products has been a critical business goal for Roche Diagnostics. These approvals allow the Company to continue to sell its IVD products after December 7, 2003 in the European Economic Area (EEA). December 7th marks the end of a 3 1/2-year transition period granted by the European Parliaments and the Council of 27 October 1998 under its In-Vitro Diagnostic Directive (IVDD) calling for all IVD manufacturers to comply with the requirements of Directive 98/79/EC for CE marking, if they wished to place IVD products in the EEA market after this date.
Roche's newly CE Marked products include RMS' innovative AMPLICOR tests, COBAS AMPLICOR automated tests, and the company's COBAS AmpliScreen automated blood screening product line. The Company also received CE Marks for tests that run on their latest advancement in PCR automation, the COBAS TaqMan 48 Analyzer. The two tests to receive CE Marking are the COBAS TaqMan HBV Test, and the COBAS TaqMan HIV-1 Test. The COBAS TaqMan 48 Analyzer is designed for clinical diagnostics laboratories that are seeking a solution to the complexity of molecular diagnostic testing and require a single, simple system for all of their real-time PCR needs. The process known as "real-time PCR" offers significant advantages to diagnostic laboratories in terms of efficiency and productivity. Along with the increase in speed, real-time quantitative PCR can help reduce the threat of contamination, as the entire test takes place in a sealed tube.
According to the European Diagnostic Manufacturers Association (EDMA), the CE marking of a device operates as a kind of "passport" to the European Economic Area. When initially conceived more then a decade ago, it was a mark to facilitate the work of customs and other enforcement authorities. Design and manufacturing requirements have now become so demanding in terms of safety, quality and performance, that the CE Marking of medical devices is now a mark of quality, according to the EDMA.
Roche Diagnostics has strict global manufacturing guidelines to adhere to, and its internal proficiency and quality control release programs help to ensure delivery of consistent, high-quality products. Roche Diagnostics is also building a new state- of-the-art manufacturing facility in New Jersey (USA) for its PCR-based IVD products. When completed, it will be the world's largest molecular diagnostics manufacturing facility.
AMPLICOR, COBAS AMPLICOR, COBAS, TaqMan and AmpliScreen are trademarks of a member of the Roche Group.
Source : Roche Molecular Diagnostics View archived contact details
Posted on December 5, 2003