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 […]
It’s hard to keep up with all the work and the new publications of guidance these days. Abundance creates its own problems one could say, so that’s why this blog was slightly delayed. Due to the COVID-19 epidemic I have had to home quarantine the family, move the whole law firm to a virtual platform […]
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 […]