European Commission Accelerates Eudamed Registration Ahead Of Planned Timetable
Executive Summary
Registration in the European medical device database, Eudamed, is a cornerstone of the full functionality of the Medical Device and IVD Regulations. After fitful progress with Eudamed development, advances are now being announced.
You may also be interested in...
European Commission Formally Pledges Eudamed Modules On Rolling Basis
A formal notice ends the debate over the legality of making modules of the new Eudamed 3 medical device database available as soon as they are ready.
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.