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Regulatory Focus™ > News Articles > 2020 > 1 > Updated: EC Discusses Notified Body Designation Progress

Updated: EC Discusses Notified Body Designation Progress

Posted 22 January 2020 | By Zachary Brennan 

Updated: EC Discusses Notified Body Designation Progress

The European Commission (EC) this week offered a detailed update on its designations of notified bodies (NBs).

Currently, nine NBs have been designated, including three from the Netherlands, four from Germany, one from Italy and one from the UK. The slow progress has experts concerned that there will not be enough NBs designated by the MDR’s date application on 26 May, which could lead to device shortages.

But the EC maintains that of the 49 current NBs, 86% (40) have applied to be designated under MDR and a total of 38 on-site inspections were conducted in 2018 and 2019, with two more pending this year. Still, that’s just one more application than was revealed since last May.

European commissioner for health Stella Kyriakides also said last month that the designation process has been sped up and that by the end of the first quarter of 2020, she expects there will be 20 designations.

On the In Vitro Diagnostic Regulation (IVDR) side, progress has been even slower, but the regulation will not be applied until 26 May 2022.

Three NBs have been designated so far under IVDR, and 50% (10/20) of the current NBs have applied. The 11 total applications is just one more than the EC announced last May. Meanwhile, seven on-site assessments under IVDR were completed in 2018 and 2019, with two pending this year, the EC says.

In addition, the EC says 24 NBs have submitted corrective and preventive action (CAPA) plans under MDR and IVDR, which compares with 13 CAPA submissions last May.  

State-of-play of joint assessments of Notified Bodies in the medical device sector

Editor's note: A previous version of this story said that the EC update appeared to show how three additional notified bodies were awaiting publication in the Nando database as designated under the Medical Devices Regulation (MDR), but it appears those three were part of an MDR and IVDR tally, and may have been the recently announced designations of MedCert and Dekra for MDR, and BSI Netherlands for IVDR. We regret the error and will keep you updated on any new NBs that are officially designated.

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