The European Commission (EC) announced this week that it will now be accepting remote audits during the pandemic for some European medical device and in vitro companies. The cleared pathway comes in time for upcoming deadlines in May 2021 and 2022 for the EU’s MDR (medical device regulation) and IVDR (in vitro diagnostic regulation). The remote audits will only be accepted when necessary and should not replace in-person audits once it is safe to do so. Details surrounding how remote audits should be conducted were left to the member states, with expectations of notifying the EC on methodologies and rationales for their use.
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