On 18 May 2020, the European Commission published in the Official Journal of the European Communities ‘Implementing Regulation (EU) 2020/666 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies’.
The 920/2013 regulation detailed “a common interpretation of the main elements of the criteria for designation of notified bodies laid down in Directives 90/385/EEC and 93/42/EEC”, which included stricter competent authority (CA) oversight of notified bodies (NBs), including mandatory on-site audits of NBs.
Because of the delay in the date of application of the Medical Devices Regulation (MDR, 2017/745) due to the coronavirus pandemic, NB designations by CAs under the MDD and AIMDD must be extended, but if on-site visits continue to be a legal requirement, these designation extensions cannot be processed.
The new Implementing Regulation removes the requirement for NB designating authorities to include on-site visits when processing NB re-designation requests with immediate effect. This will allow many NBs to continue to carry out the work necessary for device manufacturers to maintain their MDD/AIMDD certificates during the one year delay to the MDR date of application.
The Implementing Regulation makes it clear, however, that the designating authorities must still “assess an appropriate number of notified body’s reviews of the manufacturer’s clinical evaluations and file reviews, surveillance on-site assessments and observed audits”.