It had been been in the works for some time, although it also seemed unlikely for quite some time that this would happen. The implementation of the IVDR had been the slow little, neglected sister of the MDR implementation with greatly insufficient notified body capacity becoming available, and crucial elements of regulatory infrastructure (like the reference labs) still missing.
The MDCG published the Joint Implementation Plan for the IVDR in which it stated that there were serious issues with the I [...]
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