MDCG 2020-11 – Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation – April 2020

24 Nov 2020 | MDCG

Theme Designation and monitoring of Notified Bodies (NB)
Target audience Authority responsible for Notified Bodies
Products concerned MD, AIMD
Documents mentioned Commission Implementing Regulation (EU) 2020/666 of 18 May 2020 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies

 

This guidance clarifies the activities that will need to be carried out by designating authorities in the exceptional circumstances related to COVID-19 and postponement of the date of application of the MDR (EU) 2017/745 :

  • Renewal of designations under the Directives of NB whose designation expires in the period from 26 May 2020 to 25 May 2021.
  • Monitoring and Surveillance activities