Three more NBs announced for MDR

During the last month, three more notified bodies have been added to the NANDO listing for the Medical Device Regulation (MDR, 2017/745), these being:

• DNV GL Presafe AS (NB#2460) Norway on 6 February 2020;
• National Standards Authority of Ireland (NSAI) (NB#0050) on 13 February 2020; and
• DEKRA Certification B.V., (NB#0344) Netherlands on 6 March 2020.

This now makes 12 notified bodies now designated under the MDR, with less than 100 days to go before the Date of Application (DoA): 26 May 2020.

According to the NANDO listing, no new notified bodies have been designated under the In Vitro Diagnostics Regulation (IVDR, 2017/746) since December, although the BSI Netherlands NANDO posting was updated on 7 February 2020.

According to the European Commission, the state of play for applications is that 44 have been received under MDR and 11 under the IVDR, however, there remains a significant shortfall from the numbers promised by the Commission last year.

For those UK companies that have been hit by the withdrawal of their notified bodies from the medical devices market, MHRA is offering a degree of protection which will hopefully allow them to continue doing business until they can find a new notified body.