Because of the postponement by one year of the date of implementation of the MDR (EU) 2017/745 Medical Devices Regulation (May 26, 2021), the European Commission published a new implementing Regulation (EU) 2020/666 on the renewal of designations, the surveillance and the monitoring of the Notified Bodies (NBs).
The new regulation modifies the implementing Regulation (EU) 920/2013 and allows the Notified Bodies designated in accordance with Directives 90/385/EEC and 93/42/EEC, to certify Medical Devices for an additional year, until May 25, 2021. In this way, adequate supplies of Medical Devices and equipment can be ensured during the health crisis caused by COVID-19. Moreover, Manufacturers of EC-marked Medical Devices may maintain their access to the European market during this new transitional period.
It has been considered necessary to modify the previous regulation due to the extraordinary circumstances caused by the COVID-19 emergency. Actually, the impact has been considerable on the activity of the Notified Bodies of the member States and of the European Commission as regards the renewal of the designation process, both surveillance and monitoring activities related to NBs.
Particularly, the new Regulation, published in the Official Journal of the European Union on May 19, 2020, refers to the Notified Bodies whose MDD and AIMDD designations expire before the date of application of the MDR (EU) 2017/745. During this time period, Notified Bodies must in any case be subject to surveillance and monitoring by the designating authorities.
In order to decide on the renewal of a designation, the designating authorities shell carry out an assessment and trough the NANDO system they shell inform the Commission about their decisions. Such decisions shell automatically expire on May 26, 2021.
MDR (EU) 2017/745: rely on our Thema experts!
The postponement of the date of application of the MDR 2017/745 Medical Devices Regulation to May 26, 2021 offers the opportunity to organize in time. In addition to the usual strategic-regulatory consulting services, THEMA offers a package, in digital form, that allows the consumer to operate independently with regard to essential requirements: “MDR Emergency Kit“ is an excellent solution for Economic Operators of Medical Devices.
Contact us for more information and costs: Thema Staff tel. 0542 643496 / email@example.com