Germany-based TÜV SÜD Product Service GmbH Zertifizierstellen is now the second notified body (NB) to be designated and notified under the EU Medical Devices Regulation (MDR).
TÜV SÜD (NB 0123) is now listed alongside BSI UK (NB 0086), which was the first NB designated in January of this year, in the European Commission’s New Approach Notified and Designated Organisations (NANDO) database. The notified body numbers have remained unchanged.
TÜV SÜD’s designation under the EU’s in vitro diagnostic regulation (IVDR) is still ongoing and is expected to be completed by the end of the summer. To this date there are no NBs designated under the IVDR yet.
TÜV SÜD has a large capacity and the NB claims to have over 500 medical experts, engineers and doctors around the globe. It has been suggested that TÜV SÜD accounts for a third of all EU medtech notified body activity.
Current predictions are that there could be up to 10 notified body designations by the end of this year in total under the two Regulations, but that this figure is not likely to rise above 20 by 26 May 2020, when the MDR fully applies.
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