The European Commission published guidance Wednesday for European Union member states and other parties regarding the application of certain In Vitro Diagnostic Medical Devices Regulation (IVDR) provisions in the absence of a Eudamed database.
The commission said that the guidance “intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until Eudamed becomes fully functional.” The guidance will allow member states and others to meet obligations now that IVDR’s staggered rollout has taken effect, while reducing additional burdens.
The guidance is aimed at cases where “the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of [the in vitro diagnostic medical devices directive,]” the commission stated.
The European Commission recently updated its timeline for a fully functioning Eudamed, aiming to have the medical device database completely available in the second quarter of 2024.
Eudamed is a database that will register every medical device authorized for use across the 27-member European Union, and allow national medical regulators and device makers to know of authorized use of devices, safety issues, recalls and new regulations.