Commission Issues New Guidance On Registering And Identifying Legacy Devices In Eudamed
Executive Summary
The process for registering legacy devices is like that for registering devices in conformity with the MDR. But there are differences and manufacturers also need to understand how deadlines impact them.
You may also be interested in...
How To Register In Eudamed By The December Start Date: Commission Explains
The start date for voluntary registration in the Eudamed 3 database is fast approaching. It is open to all medtech manufacturers with CE marked medical devices from 1 December.
EU Regulatory Experts Support Notified Bodies, But Argue For Greater Consistency
Notified bodies have been a pivotal part of the EU medtech regulatory system since it was first launched in the 1990s. Where might they fit within a new medtech regulatory governance structure? Panelists on a recent vodcast grappled with the question.
First Public Discussion On How EU Medtech Regulatory Governance Structure May Evolve
Does the EU need a medtech agency for the first time in its history? Nothing can or should be decided too quickly but five high-profile experts broadly agreed that change is now critical.