On 11 January 2021, in view of the exceptional circumstances created by COVID-19, the European Commission finally published a Notice expressing their views on the application of extraordinary measures, including remote audits, under the Medical Device Regulations (MDR & IVDR). It allows the remote audits under certain conditions.
Already last year, COCIR urged regulators to allow conducting initial MDR certification audits remotely for all devices. This Notice is thus a positive step to ensure the continued availability of innovative medical devices to European healthcare systems. COCIR with its members, will continue to monitor the application of this Notice and the progress of MDR certification until the Date of Application on 26 May 2021.
The Notice can be accessed here.