NEW YORK – The European Commission last week issued a decision to designate Dekra as a notified body for overseeing compliance with the new In Vitro Diagnostic Regulation.
The Berlin-based company is the first to be designated and more NBs expect they will be designated by year end. The EC published its decision concerning Dekra on Oct. 10.
Dekra is an international safety organization that tests and certifies medical devices and IVDs, in addition to automotive, consumer, and other products. The company claims on its website to be among the top NBs in Europe for certifying medical devices and IVDs under the existing Medical Device Directive and In Vitro Diagnostic Directive.
Europe however is transitioning to new, more stringent regulations under the IVDR, which require most IVDs to be cleared by a designated standards organization, called a notified body, by May 2022. Until last week, though, no NB had been designated by the EC to certify IVDs under the new regulations, prompting industry concerns about a regulatory bottleneck that could potentially delay the availability of molecular tests.
Dekra was designated to certify medical devices under the new Medical Device Regulation in August, becoming one of the first NBs to achieve the designation. The MDR is set to come into force in May 2020. A number of other NBs that have been already designated under the MDR, including BSI Netherlands and TÜV-SÜD, have speculated that they might also be designated under the IVDR by the end of the year.
The Brussels-based European Association of Medical Devices Notified Bodies (TEAM-NB) carried out a survey of its membership in January that showed that 11 of its members intended to seek designation under the IVDR. Two of those members, LRQA and UL UK, later decided not to pursue designation under the IVDR, meaning the number of NBs seeking designation is now below 10.