Notice to third country manufacturers of SARS-CoV-2 IVDs

The competent national authorities have identified several common issues while implementing market surveillance activities (presented below) to ensure the compliance of IVDs with the applicable EU regulatory requirements.

As a result, the Medical Device Coordination Group (MDCG) published a new Notice to third country manufacturers located outside the EU, or the EEA who are placing their in vitro diagnostic medical devices (IVDs) meant to detect the presence of and/or exposure to SARS-CoV-2SARS-CoV-2 on . . .

 

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