EU LAUNCHES FIRST ‘EUDAMED’ MODULE, BUT MDR/IVDR BOTTLENECK REMAINS
December 2nd, 2020
THE EUROPEAN Commission on Tuesday (December 1) launched the first component of its behind-schedule IT system for registering certified medical devices, but an ongoing regulatory bottleneck could render many products impossible to certify for some time.
The first of six modules of its EUDAMED system will assign a ‘single registration number’ (SRN) to each medical device manufacturer, producer of procedure kits, importer, and a European Union (EU)-based representative of non-EU manufacturers. (1) But EUDAMED is incomplete and its roll-out two years behind ...
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