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DEKRA Certification BV, based in the Netherlands, has been appointed as the fifth notified body under the IVD Regulation.
Its listing under the new regulation, which fully applies from 26 May 2022, appears on the European Commission Nando database of notified bodies designated under the IVDR.
IVD manufacturers are being encouraged to have their products assessed as soon as possible under the IVDR; only a small percentage will be able to benefit from the grace period which will allow their products to remain complaint with the IVD Directive up until 26 May 2024, on certain conditions. The vast majority, some 85%, will need to meet the 2022 deadline, and bottlenecks are predicted.
The situation is so acute that the European Commission’s devices expert, Erik Hansson, made a direct plea at the RAPS Euro Convergence meeting for more organizations to apply for IVD Regulation notified body status. Hansson predicted capacity issues this autumn at IVDR designated notified bodies, and into spring of next year. (Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble)
The other four notified bodies designated under the IVDR are: BSI Group in the Netherlands, and three German notified bodies: DEKRA Certification GmbH, TÜV Rheinland and TÜV SÜD. This means that all EU notified body IVDR capacity at present is in Germany and the Netherlands.
DEKRA Certification BV has been designated for a very broad range of IVDs types, as well as a long list of horizontal technical competencies such as devices intended to be used as companion diagnostics,and IVD devices which require knowledge of tests of cell function and of parasitology.
It is already designated under the Medical Device Regulation (MDR) and was appointed as a notified body under all three medical device directives.
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