Finally and just in time for the date of application of the MDR: here it is, the book that I’ve been working on for a long long time.
It turns out that writing books while having a more than full-time job running a law firm and being a busy lawyer is a bit of a challenge.
I chose not to do this via a publisher but rather self-publish because in my long career as a publishing legal writer I have been consistently underwhelmed and sometimes badly disappointed by what a publisher does for an author (the good people at RAPS being the positive exception by the way).
But here we are now and there you have it: the first book that I am aware of about the MDR and IVDR that contains this degree of commentary on the entire MDR and IVDR at state of the art around the date of application of the MDR, available as a stamped PDF (like when you buy an ISO standard) or as an ePub format eBook that you will be able to read on your tablet of choice with basically every e-reader software. I recommend using a good quality tablet with a color screen to read the book, because it has nice colors and high resolution flow charts and diagrams in it.
An esthetically pleasing tool
The book is set up as claimed in the title (intended purpose, right): it’s an enriched of the MDR and IVDR texts in that it provides:
- An introductory chapter describing the history of the medical devices directives and EU medical devices policy, explains why the MDR and IVDR turned out the way they did and discusses them on a high level (part 1);
- The current text of the MDR including annexes with comments on an article by article and clause by clause basis for both the regulation and the annexes (not all articles and clauses have been commented yet, but this will grow over time). All implementing acts, MDCG and CAMD guidance, European Court medical devices case law and a lot of notified body and branch association guidance are all discussed in context of the articles and clauses of the MDR (part 2);
- Same for the IVDR (part 3);
- A section with sources of reference materials, helpful for staying informed and finding furthter information (part 4); and
- A section with a number of useful tables, such as a comparison table between the MDR and IVDR (so the IVD industry readers can easily see which wheels have already been invented in the general devices world) and a comparison table between the clinical investigation provisions in the MDR and the Clinical Trials Regulation (since the legislator’s intent was that they should align to a high degree) (part 5).
I’ve tried to write this book as a tool that I like to use in daily practice myself, and not as a pretty paperweight.
This is why I decided to go digital only for the moment and make the book easy to navigate with crosslinks from the table of content to every article in the MDR and IVDR and make as much content as possible on the internet directly accessible from the book as URLs, so you can quickly get to the underlying sources. Of course this can be improved and it will be in future editions.
Since it is all digital text, it’s full text searchable! Very convenient compared to paper books.
Last argument against paper (I’ve looked into print-to-order possibilities) is that the book would become prohibitively expensive if you want a book of nearly 1200 pages (the PDF version) printed and bound in good quality that can take a beating in daily use. However, if there is a big ask for paper versions, I can explore a paper option.
Most legal and regulatory books are intensely boring, not very appealing to look at and underwhelming from a design perspective. I wanted something different and more appealing so I’ve invested in a specific design language for the book. My law firm’s designer Hamid Sallali (http://thisishamid.com) did a great job on the design and coached me through the development process with a lot of patience and humor – if you need great digital graphic design he’s your man. I believe that a book should be esthetically pleasing and easy on the eyes. For that reason we have payed extra attention to layout with a non-standard and beautiful font that is specifically easy to read on a screen, good quality images in colour and appealing design elements for separator pages.
Of course there are still things that can be improved, and they will be in later editions. Please send any feedback to email@example.com.
No person is an island, and neither am I. This book was proofread at various stages of completion by a group of people that I hold in high regard in the medical devices field: Sabina Hoekstra-Van den Bosch, Amélie Chollet, Kees Macquelin, Bassil Akra and Ronald Boumans.
They each provided very valuable input and useful different perspectives on purely personal title. All remaining mistakes and inaccuracies are my own of course.
And then there is the contribution of two other people that I have the privilege of working with on a daily basis: my awesome colleague Cécile van der Heijden who was instrumental for the data protection (GDPR) and clinical investigation entries and my fantastic paralegal Thijs Mooren who continuously helped tame the ever expanding manuscript, made sure that the right information ended up in the right place, made flowcharts and took care of all horizontal referencing between the MDR, IVDR and old directives and other features that make the book more usable and useful.
Developments and discounts
One of the advantages and disadvantages of a book is that it is fixed content: you can easily carry it around in your tablet or computer without need for connectivity, but it is fixed content. Please be mindful of this when using the book. The MDR and IVDR are in full flux still and there is a lot happening in the field of horizontal legislation, like Turkxit apparently having been averted in the last days before DOA, Swixit still under hectic negotiation, the Market Surveillance Regulation becoming applicable as of 16 July, the proposal for the AI Regulation, the proposal for product liability class actions in the medical devices and IVD space, notified bodies being held liable for insufficient surveillance of manufacturers, revision of the GDPR and so on.
Documents on the internet may move, links may be broken (one of the reasons for delay of the book was that I had to correct a lot of links in footnotes that turned out not to be valid anymore). Even some new MDCG guidance became available in May 2021 that I was not able to process for the book anymore.
Accordingly, the book (while up to date as per beginning of April 2021) will not capture developments after that date.
A next edition will close that gap of course, and readers that buy this first edition in the first two months after the date of application of the MDR (so before 26 July 2021) will receive a discount code for a 20% discount that can be applied to their purchase of the second edition.
If you are working for a competent authority or another public institution involved in the devices field, I know that you will probably not have any budget to buy flashy eBooks but may still be interested in this book.
If you think it would be useful to have this book for your work, please send me an email (firstname.lastname@example.org) and I will provide you with a copy for free.
If you are a university or other teaching institution and would like to include the book in your curriculum, that would be awesome! Send me an email and I will make sure that your students will get a good deal.
Come and get it!
Oh, and finally – you can get the book here in PDF (to use on whatever PDF reader on any device that you like) and in ePub format (to use specifically on eReaders):
I hope that the book will be useful for you and that you’ll enjoy using it. If you like it, tell others – if you don’t, tell me.