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Notified Bodies’ designation procedures under IVDR & MDR – high level summary in numbers

Posted on 02.05.2019

Almost 12 months before the MDR’s date of application and nearly 18 months after applications opened, here are the most updated figures on the notified bodies’ designation procedures under the MDR and IVDR:
• 47 notified body applications have reached the European Commission’s DG SANTE and our analysis concludes that these have likely been submitted by an estimated 35-40 notified bodies (out of 58 designated under the Directives).
• Out of these 47 applications:
o 11 have reached the post-joint assessment audit stage (2 under IVDR; 9 under MDR)
o 32 applications have already been or are scheduled to be audited until July 2019 (6 under IVDR; 26 under MDR)
• We understand that so far the MDCG has issued 2 recommendations on notified body designations: one for BSI UK under the MDR earlier this year (see NANDO) and one for another notified body, still unknown to the public, for which notification is pending.

Some of these numbers are extracted from the update on notified body designation published by the European Commission on 23 April 2019.