Corrigendum 2 and the (potential) consequences for class I devices
Everybody has been in enormous suspense about how the second corrigendum to the MDR and IVDR would turn out. The version that came out of the European Parliament’s ENVI committee vote contains a number of very technical points that I will not elaborate on. But it also contains the big break for certain class I devices, the ones that are either up-classified under the MDR (and need a CE certificate under the MDR as a result) and the re-usable surgical instruments (which need a CE certificate for the re [...] « Read the rest of this article on
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