As a result of the Covid-19 pandemic, device manufacturers preparing for compliance with the Medical Device Regulation (MDR, 2017/745) have suffered delays with notified body audits, because of travel restrictions. The Commission has therefore decided to allow ‘virtual audits’ under certain conditions, and has published a ‘Commission Notice‘ in the Official Journal to set out these conditions.
The Notices states there is a “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”, and that this need has been “recognised by the MDCG and supported by the vast majority of the Member States”.
The circumstances under which notified bodies may carry out virtual audits is therefore subject to the following conditions:
— be limited in duration, namely any notified body’s decision on certification is limited to the time strictly necessary to allow for a proper on-site audit to take place as soon as possible;
— be identified and justified on a case-by-case basis, and the individual circumstances should be documented and duly substantiated by the notified body; and
— not go beyond what is required to ensure continuous availability of safe and performant devices, when concrete obstacles to complete conformity assessments on-site have been created by COVID-19 circumstances.
The Notice comments that: “The above-mentioned temporary extraordinary measures taken in response to the exceptional circumstances of the COVID-19 should only be used during a limited period of time until on-site audits are again possible.”