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 geographic scope of the regulations and details on Brexit and Swift and additional text on the relation of the regulations to other product and horizontal regulation.

The book was updated for the new Blue Guide 2022 and all references to the Blue Guide were updated for the 2022 version of the Blue Guide.

We fixed as many broken hyperlinks to sources on the internet as we could.

A lot of extra detail on the IVDR has been added, including discussion of the early January 2022 amendment that changed the transitional regime drastically.

Again I owe a debt of gratitude to the proofreading panel composed of Sabina Hoekstra-Van den Bosch, Amelie Chollet, Bassil Akra, Ronald Boumans, Kees Maquelin and Agnes Szoboszlai, who proofread parts of the book on strictly personal title.

The PDF version of the book is available here.

The ePub version of the book is available here.

Discount codes for the second edition were provided to readers that purchased the first edition – this is your time to redeem them! If you buy the second edition, you will receive a discount code for the third edition.

Competent authorities can get free copies again like with the first edition – just drop me an email at and I will send you a discount code for a free copy (a notified body is not a competent authority – but you can always enter into a structured dialogue with me).

Like with the first edition I hope that the book will be useful for you and that you’ll enjoy using it. If you like the book, tell others – if you don’t, tell me.