Today (25-September) the Medical Device Coordination Group (MDCG) has published “MDCG 2021-4 Rev. 1 Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746″
According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body.
In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU reference laboratory (EURL). This document provides indications for how to apply the IVDR provisions related to expert panels and EURLs before the IVDR application date.
This document provides updates from the previous revision released in April 2021.