Those working in the industry will be aware that the implementation of the IVDR has been far from straightforward, and that there is still a lot of work to be done.

The European Union is proposing to delay the go-live date for the incoming medical device regulation pertaining to In Vitro Diagnostics for products that still need assessment of a notified body.

The Medical Device Coordination Group (MDCG) has published guidance MDCG 2021-21 “Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices” – the document is critical for all manufacturers who manufacture and have CE marked COVID-19 tests under the IVD Directive (IVDD).