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What is this book?
The Enriched MDR and IVDR eBook is an eBook in PDF format containing an enriched version of the legal texts of the EU medical devices and IVD regulations:
- Medical Devices Regulation (Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC) (the “MDR”); and the
- IVD Regulation (Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (the “IVDR”)).
Enriched means that the legal texts of the regulation have been commented on and clarified on a recital by recital and clause by clause basis, including the annexes to both regulations. Where possible I have referred to external third party sources such as MDCG guidance, competent authority guidance, notified body guidance and guidance documents from industry associations MedTech Europe, COCIR and EFPIA. In addition the eBook contains numerous flowcharts for the application of certain specific clauses and many diagrams explaining regulatory concepts.
What is new in the second edition?
The legal texts and comments are accurate as per 1 September 2022, the date on which the manuscript text was closed. Compared to the first edition almost 240 additional pages of substantive commentary covering developments since the first edition was added, obsolete text was revised and new flowcharts and diagrams have been added.
Although many more provisions of the regulations have been commented on compared to the first edition there is not a 100% coverage yet. More clauses will be commented on and more flowcharts will be included in subsequent editions as more guidance and policy about the two regulations becomes available.
Note that the MDR and IVDR are legislation still in development: a lot of guidance is still being added and the regulations may (have) be(en) amended from time to time themselves or implenting legislation may (have) be(en) adopted. Like with any static text in a book, make sure always to double check the actual situation at the time.
What will you get?
The eBook of 1393 pages (including the MDR and IVDR legal texts) consists of five parts:
Part 1: an introductory chapter providing a high level introduction and description of both regulations and their political background;
Part 2: the enriched version of the MDR (i.e. legal texts plus commentary);
Part 3: the enriched version of the IVDR (i.e. legal texts plus commentary);
Part 4: references to various sources of publication of EU medical devices law and guidance; and
Part 5: comparison tables between various regulations: an overlap table between the MDR and IVDR, an overlap table between the Annexes of the MDR and IVDR, an overlap table between the clinical investigation provisions in the MDR and the Clinical Trials Regulation.
Praise for the first edition of this book:
- "your book is AMAZING!!!" - specialized EU medical devices lawyer
- "Great resource for any RA specialist!" - medical devices RA specialist
- "This book is an important ‘missing link’ between all the medical device and IVD relevant EU regulatory documents." - medical devices and IVDs RA specialist
The book is delivered to you as a PDF document stamped with your personal details that you can use with any PDF document viewer.
You will get the first eBook about the MDR and IVDR that both incorporates the legal text and discusses the two regulations in this level of detail and brings together all existing authority, notified body and trade association guidance in one document.