Fourth notified body designated under IVDR

Regulatory NewsRegulatory News | 17 June 2020 |  By 

Germany’s TÜV SÜD Product Service GmbH Zertifizierstellen on Wednesday became the fourth notified body designated under the In Vitro Diagnostic Regulation (IVDR).
TÜV SÜD, Germany’s second notified body under the IVDR, joins Germany’s DEKRA Certification GmbH and BSI’s UK and Netherlands arms, BSI Assurance UK Ltd and BSI Group The Netherlands B.V.
The newly designated notified body will be a welcome addition for industry, as the number of notified bodies designated under the IVDR has lagged significantly behind those designated under the Medical Devices Regulation (MDR).
While there are still nearly two years before the date of application of the IVDR, industry group Medtech Europe has called to delay the regulation by a year, as was recently done for MDR. (RELATED: MDR delay official as industry calls to push back IVDR, Regulatory Focus 24 April 2020).
In a press release, Andreas Stange, vice president of medical and health services at TÜV SÜD, urged companies to begin preparing for IVDR well ahead of the date of application.
“Unless already done, manufacturers of in vitro diagnostics should get ready for the IVDR immediately to avoid bottlenecks in the testing and certification of their devices,” he said in a press release. TÜV SÜD notes that the share of IVDs that will require assessment by a notified body is expected to rise from 15% to 90% under the IVDR.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy