On 11 January 2021, the European Commission published an Information Notice in the EU Official Journal (available here in all EU languages) which seems to confirm that Notified Bodies may temporarily deviate, in extraordinary and individual cases, from the IVDR/MDR requirement for audits of the manufacturers’ quality management systems (QMS) to take place ‘on site.’
This Notice does not modify the legal texts of the Regulations, however, recognises that Member States – who are responsible for the monitoring of Notified Bodies – may exercise discretion in allowing (case-by-case and temporarily) QMS audits under the IVDR/MDR to take place virtually/remotely, in cases where this is justified, e.g., because the continued supply of devices to the market is otherwise at stake.
Furthermore, the Notice communicates that the Medical Devices Coordination Group (MDCG) has recognized the need for virtual QMS audits under the IVDR/MDR, and that this is “supported by the vast majority of the Member States.”
While this is a positive development, some question marks remain with regards to the practical implementation at EU Member State level. A key aspect of this issue is a harmonised approach by all the EU Member States.
