Happy IVDR day my readers! My apologies for the low level of activity on this blog the last time. I’ve been very busy with MDR and IVDR work.
And of course I have been working hard on the second edition of the big book, the Enriched MDR and IVDR, which is nearing completion and will additionally cover regulation amendments, new guidance, amended guidance and other developments during the period of early April 2021 to the date of application of the IVDR. Hundreds of pages of additional content, out [...] « Read the rest of this article on