IVDR Notified Body Numbers – Has Enough Progress Been Made?
Will there be enough resources for IVD manufacturers to be audited in time against the EU's IVD Regulation? A survey from TEAM-NB reveals a drop in notified body numbers just at a time when more resources are needed.
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The European Commission looks to be on track, and in some cases ahead of schedule, in steps toward the designation of notified bodies under the new EU device and diagnostic regulations. But could recent bad press create delays?