In August 2020, the Medical Device Coordination Group (MDCG) announced that the economic operator registration or actor registration module will be available as of December 1, 2020. This module will serve… Read More
In a recent article we have reported that the EUDAMED economic operator registration module will be available as of December 2020. The corresponding registration will trigger the assignment of a… Read More
Last year, the European Commission has announced that EUDAMED 3 as one central aspect for the implementation of important medical devices regulation (MDR) and IVD regulation (IVDR) mechanisms, will not… Read More
The European Commission wants to permit early access to SRN before Eudamed launches in 2022 Eudamed will be delayed by at least two years. However, upon pressure by local country… Read More
From different sources we have heard that the introduction of EUDAMED will be delayed – probably for two years. In the meantime, this has been confirmed on the European Commission’s… Read More
The European Commission’s Medical Devices Coordination Group (MDCG) recently published two guidance documents on timelines for device registration and on registration expectations for manufacturers of legacy devices. Legacy devices in… Read More
