MDCG 2022-1 Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices

2023-03-29T14:47:07+00:00January 12th, 2022|Categories: Compliance, Covid-19, Europe, Regulatory|Tags: , , , |

The MDCG 2022-1 Notice has been published It is addressed to manufacturers of SARS-CoV-2 IVDs based in a third country and who place or intend to place their in vitro diagnostics on the EU market. It highlights a number of common issues [...]