It took a while, but here it is: the 2nd edition of The Enriched MDR and IVDR, updated with developments from early april 2021 to early September 2022.
The first edition of the book was revised thoroughly, many new clauses in the MDR and IVDR were annotated and obsolete information was removed.
New flowcharts and diagrams were added.
Parts 1 (introduction) and 5 (tables and references) were expanded. Part 1 now includes, for example, more background to the regulations, discussion about the ge [...] « Read the rest of this article on