Today, 28 May, the European Commission published two important calls for stakeholders of the medical devices’ sector. The first published initiative is a call for…
Transitional provisions for Class D IVDs: Updates to MDCG 2021-4
In September 2024, the MDCG published a revised version of MDCG 2021-4. This guidance addresses the application of transitional provisions for certification of class D…
IVDR Joint Implementation Plan has been published!
The Medical Devices Coordination Group (MDCG) has issued a joint implementation and preparedness plan for the In Vitro Diagnostic Medical Devices Regulation (IVDR). This plan…
First EU Reference Laboratories designated under the IVDR!
The European Union designated on 5 December 2023 its first EU reference laboratories (EURL) for vitro diagnostic devices. In July 2022, the European Commission opened…