Breaking IVDR/MDR News - today the European Commission published an information Notice to confirm that Notified Bodies may temporarily deviate, in extraordinary and individual cases, from the IVDR/MDR requirement for audits of manufacturers’ quality management systems (QMS) to take place ‘on site.’

This is a significant and positive development.

The need for virtual QMS audits under the IVDR/MDR is “supported by the vast majority of the Member States.” It is now of crucial importance that we avoid fragmented approaches amongst EU Member States.

Document 52021XC0111(01)