The 2nd edition of The Enriched MDR and IVDR is available now

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.

Navigate through our knowledgebase

Related articles


A case of so-called fiscal neutrality

Sometimes you come across cases that violate Mandalorian Creed: “One does not speak unless one knows.”. This happened to me last week when I read the Dutch Supreme Court’s judgment in a…

Read more


Can we fix / improve the MDR and the IVDR?

Or in other words that I’ve asked on this blog before: can the maker repair what he makes? This blog will argue that he can and he should. It still happens to…

Read more


MDR and IVDR amendment has entered into force now

Today is the day that the amendment, aka the ‘extension’, to the MDR enters into force because it was published in the EU’s Official Journal today, number L080. As you are reading this,…

Read more