Under Article 44(2) of the medical devices Regulation and Article 40(2) of the in vitro diagnostic medical devices Regulation, the national authorities responsible for notified bodies shall monitor the notified bodies established on their territory and their subsidiaries and subcontractors, to ensure on-going compliance with the requirements and the fulfilment of obligations set out in the medical devices Regulations. According to Article 46(4) of the medical devices Regulation and Article 42(4) of the in vitro diagnostic medical devices Regulation, where an authority responsible for notified bodies has ascertained that a notified body is failing to fulfil its obligations, the authority shall suspend, restrict, or fully or partially withdraw the designation, depending on the seriousness of the failure to fulfil those obligations.
Member States, as well as notified bodies and other stakeholders, have informed the Commission that travel and quarantine restrictions imposed in response to the COVID-19 pandemic, both in Member States and non-EU countries, have significantly affected notified bodies’ ability to conduct on-site audits on the premises of manufacturers and their supplies and/or subcontractors.
In addition, the current epidemiological indicators for COVID-19 in the EU and around the world, and the short-term forecast, make the situation more serious and increase the need to possibly take temporary extraordinary measures in specific cases when the inability of notified bodies to conduct on-site audits could raise the risk of shortages of vital devices.
Calls for the possibility to take temporary extraordinary measures, including remote audits, related to notified body on-site audits under the medical devices Regulations have been made by industry as well as notified bodies.
The potential risks related to inability for notified bodies to carry out conformity assessment activities in the context of COVID-19 circumstances and consequent travel restrictions had been discussed by the Medical Devices Coordination Group (MDCG) in their meetings in October and December 2020. As result, the potential need, in exceptional circumstances, to take temporary extraordinary measures, including remote audits, was recognised by the MDCG and supported by the vast majority of the Member States.
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