The European Union’s (EU) European Commission (EC) will temporarily allow remote audits for some European medical device and in vitro diagnostic manufacturers, reports Regulatory Focus.
The temporary step takes into account the “exceptional and unforeseen circumstances caused by the COVID-19 crisis,” according a notice issued by the EC on Monday. Both industry and notified bodies had felt hamstrung by the complete stall in inspections caused by the coronavirus pandemic.
The inability to complete audits had been additionally anxiety-provoking given looming deadlines for the EU’s medical device regulation (MDR) and in vitro diagnostic regulation (IVDR), coming in May 2021 and 2022, respectively.
Read more from Regulatory Focus.