Netherland’s DEKRA Is Latest Notified Body Designated Under EU IVDR
Executive Summary
With most IVDs needing to be compliant with the EU’s new IVD Regulation by late May 2022, many more testing bodies are urgently needed. The designation process is limping along, but a fifth organization has been named at last.
You may also be interested in...
Commission Calls For Notified Body Applicants As It Recognizes EU IVD Industry In Some Trouble
The European Commission is publicly recognizing the huge hurdles ahead for the IVD industry in complying with the IVD Regulation. Delaying the regulation has long been off its agenda, but it is struggling to find solutions.
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.