FYI -IVDR/MDR News
Published
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.
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)
Source: https://www.linkedin.com/posts/activity-6754334341024751616-8kBU
News
Medical Device Division (Formerly Biomedical Division)
01/12/2021 7:01pm CST
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