Finally, double digits! The number of notified bodies accredited under the MDR climbs to 11

Miriam Schuh

All notified bodies accredited under the previous legal regime (MDD/AIMDD) will lose their status once the MDR takes effect on 26 May 2020 and will have to be reaccredited in accordance with the MDR as of that date. Still, a 11th notified body has now been accredited under the MDR: DNV GL Presafe AS in Norway, an EFTA state (Nando database). The low number of notified bodies continues to be a bottleneck for medical device manufacturers in navigating the conformity assessment procedure and bringing innovative medical devices to market. Extended transitional periods for certain devices do little to change this fact.

[March 2020]