The European Commission’s Medical Device Coordination Group is allowing notified bodies to perform remote audits during the coronavirus outbreak, according to guidance posted 08/04/2020.
The MDCG detailed how notified bodies can run audits while quarantine orders and travel restrictions are stopping them from conducting site visits.
The pandemic-oriented guidance the day after the Council of the European Union responded to the Commission’s proposed delay of the Medical Device Regulation. The Council’s planned amendments to the proposal clear up the confusion over whether the delay applies to all aspects of MDR.