A 30th Notified Body for MDR


Less than one month on from the last addition, covered in our article here, a 30th Notified Body (NB) has been designated under the Medical Device Regulation (MDR)[1] and added onto the European Commission’s NANDO database.[2]

Our 30th NB, Berlin Cert GmbH, is unsurprisingly based in Germany. Berlin Cert has been designated to carry out conformity assessments under the MDR, and is the 8th NB based in Germany. This follows hot on the heels of a previous NB designation last month, and hopefully more will be joining their ranks soon.

They are needed to address the enormous workload, as we have discussed in our previous articles on the MDR, and in our ‘Spotlight on IVDR’ series.

Later today, we will issue a note as regards to two position papers issued by the CAMD and the MDCG, addressing the bottleneck and the backlog. Spoiler alert: It’s not the relief the sector has been seeking!

[1] Regulation (EU) 2017/745
[2] Notified Bodies Nando database for the MDR