The first module of the European database on medical devices, EUDAMED, also referred to as the Actor registration module, will be made available to EU Member States and economic operators on 1 ...

The European Commission’s Eudamed database, a critical component of the EU’s Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), launched on Tuesday with the actor registration ...

A mandate for manufacturers to register their devices or in vitro diagnostics (IVD) in a new database for medical devices in Europe is on the horizon. The European Commission (EC) has outlined six ...

The European Commission last week issued guidance addressing how manufacturers should prepare for the gradual roll-out of Eudamed called for in recent amendments to the Medical Device Regulations (MDR ...

On 15 February 2021, the European Commission published guidance on the Management of legacy devices in EUDAMED. This guidance addresses the registration and identification of legacy devices in EUDAMED ...

The Council has endorsed key updates to the law on medical devices that will help prevent shortages and ease the transition to greater transparency and access to information. The regulation approved ...

An initiative that is expected to eventually create a more reliable global marketplace and reduce the presence of illegal medical devices or in vitro diagnostics (IVDs) could inherently, albeit not ...