+39 06 5782665
Italy - UK - USA

IVDR gets fourth notified body

  • Posted by: inetika
  • Category: GLOBAL NEWS

The NANDO website for the In Vitro Diagnostics Regulation (IVDR, 2017/746) has at long last reported an increase in the number of notified bodies designated to act under this regulation, from three to four. The latest addition is TÜV SÜD Product Service GmbH Zertifizierstellen, Germany, notified body reference number 0123.

Although the date of application (DoA) of the Medical Device Regulation (MDR, 2017/745) has been delayed by one year to 26 May 2021, no such delay has been announced for the IVDR, despite calls from industry for a similar 12 month delay to the IVDR’s DoA. Industry is concerned that the still small number of IVDR notified bodies, together with travel restrictions due to the coronavirus, will impede IVD manufacturers from achieving IVDR compliance in time to meet the unchanged DoA of 26 May 2022.