Notified Bodies: 2 additional notifications under MDR
Posted on 03.03.2020
Around 100 days prior to the MDR’s date of application on 26 May, only 11 Notified Bodies (NBs) have been designated under the new Regulation (and 3 under IVDR) – more than ever, the very serious doubts on whether there is enough capacity to meet the medtech industry’s demands remain.
Recently two NBs were officially notified in the NANDO database under the MDR:
• DNV GL Presafe AS (NB#2460) in Norway on 6 February 2020
• National Standards Authority of Ireland (NSAI) (NB#0050) on 13 February 2020
According to the European Commission’s most updated state-of-play of joint assessments of NBs in the medical device sector, one more NB should be notified soon and 8 Designating Authorities’ final reports are pending.