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 . . .


Oh! It looks like you do not have access to this page.
Find the membership plan that suits you, and within a few minutes you are good to go.
Are you a member already? Log in here.