Virtual audits for the certification of medical devices to be allowed temporarily
The European Commission has issued a statement opening up for virtual audits for the certification of medical devices on an extraordinary basis and subject to individual assessments.
On 11 January 2021, the European Commission announced that due to the COVID-19 situation, it would now extraordinarily allow that the notified bodies perform virtual audits based on specific assessments on a case-by-case basis in connection with the certification of medical devices. Usually, audits aimed at ensuring high quality and verifying the manufacturing processes would take place on-site, in order to make sure that the assessment is done properly.
The European Commission notes in the statement that the lack of on-site audits should be limited in duration, and that the notified bodies should limit virtual audits to strictly necessary situations only. The purpose of the virtual audits is of course still to ensure that the certified devices are safe and performant.
These temporary and extraordinary measures are implemented in response to the COVID-19 circumstances. The aim being to help prevent the risk of shortages of such medical devices, which, due to COVID-19 pandemic, are caught up in the authorisation process and therefore cannot come on the market.
You can read the European Commission's statement here.