Notified bodies can now do remote audits for the MDR and IVDR — Member states need to Notify the EU Commission of Notified Bodies not conducting on-site audits & the period of time this will not be happening. So remote audits for these NBs won’t be happening immediately – but this is a big change! EUR-Lex – 52021XC0111(01) – EN – EUR-Lex Each Competent Authority will need to review each separate NB’s justifications and procedures separately and this is a COVID-19 exemption only so this is temporary. Once the Commission says COVID-19 crisis is over this goes away.

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