Here’s what’s new in Fundamentals of Medical Device Regulations, Fifth Edition

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Changing regulations are nothing new for regulatory professionals operating in the medical device sector, but 2022 cemented milestones no one in the profession can ignore. The fifth edition of Fundamentals of Medical Device Regulations provides a current view of regulations governing medical devices and IVD and addresses the impact of the application of EU Medical Device Regulation (EU MDR) and In Vitro Diagnostic Regulation (EU IVDR) as well as other important changes to the medical device regulatory landscape.

This seminal text provides thorough information and insights into medical device regulations. The fifth edition of the book, just published, is significantly updated to address the changing regulatory landscape and new regulatory requirements and includes:

  • 12 new US chapters  

  • 15 new EU chapters

  • 13 international chapters updated in 2021

  • abbreviations, acronyms, glossaries and indices for each section

  • direct links to the most current regulation and legislation medical devices and in vitro diagnostics (IVDs)

These revisions comprise a general update that brings this essential resource up to date. Fundamentals of Medical Devices, Fifth Edition includes the relevant chapters from Fundamentals of US Regulatory Affairs, 11th Edition, and Fundamentals of EU Regulatory Affairs, Ninth Edition, as well as Fundamentals of International Regulatory Affairs, Fifth Edition, updated in June 2021.

What’s new, specifically, in the fifth edition of Fundamentals of Medical Device Regulation?

RAPS published the fourth edition of Fundamentals of Medical Device Regulations in July 2021. The book is part of RAPS’ Fundamentals of Regulatory Affairs series, which constitutes the most extensive collection of resources available on global regulatory affairs. “These books are important because they provide an in-depth view of regulations while providing some best practices,” says Jocelyn Jennings, MS, RAC-US, RAC-Drugs, RAC-Devices, vice president, regulatory affairs and quality assurance at Mycovia Pharmaceuticals and one of the book’s lead editors. 

Since these books serve as such cornerstone pieces of any regulatory professional’s collection, they need regular updates. But why now?

Why was a revised book necessary? 

“Too many references and concepts have changed, hence the update,” according to co-editor Gert Bos, executive director of the Qserve Group and president of the Regulatory Affairs Professionals Society board of directors.

RAPS’ staff and its team of authors had two guiding missions as they went through this revision:

  • To identify and address the impact and consequences of a changing regulatory landscape and new regulatory requirements
  • To keep regulatory professionals up to date on global medical device and IVD regulations and the impact of these new regulatory requirements

What topics does the book cover? 

In addition to a current view of regulations governing medical devices and IVDs, global experts have provided important content on combination products; regulatory strategy; advertising and promotion; enforcement and competent authorities; FDA communications, meetings, and user fees; current good manufacturing practices; quality system design; preclinical testing; clinical evaluation; and clinical investigations. 

Fundamentals of Medical Device Regulations covers the entire medical device lifecycle, from product development through postmarketing.

Four ways regulatory professionals can use this book 

This updated text is a valuable resource for regulatory professionals, regardless of where they are on their career journey. 

For those new to the profession, this book can help get you up to speed with the latest information. 

For early-career professionals and students – those at Levels 1 and 2 of the RAPS Regulatory Competency Framework – Fundamentals of Medical Device Regulations provides the history behind today’s regulations and “the historical context in which those laws and regulations were developed and enacted,” as Karen Zhou, JD, MS, RAC-Devices puts it in Chapter 1 of the Fundamentals of US Medical Device Regulations section. 

For veteran regulatory professionals, this is a valuable resource puts information at your fingertips. 

“It covers the basics, so is essential for a newbie to get started,” says Bos. “But also, it is a great reference book for those  in the profession for years, as it has serious depth throughout, and also can provide information on topics that might not have been the focus of your past work.” 

For senior professionals - at Levels 3 and 4 of the Competency Framework - who are responsible for global strategy development, Fundamentals of Medical Device Regulations is there when you need it. 

The book contains a precise index, a sample of which you can view here, which puts any of the book’s information just a quick scan away. 

As a resource while you study for a RAC exam.

RAPS offers a complete menu of preparation tools to prepare regulatory professionals for a Regulatory Affairs Certification Exam. 

And since RAC Exam questions are updated after the Spring testing cycle every year to reflect current regulations, guidelines and practice, it’s best to work with the latest information. Incorporating Fundamentals of Medical Device Regulations into your RAC study toolset will ensure you have the most up-to-date guidelines available, just an index search away. 

Of course, no one should pick just one resource on their RAC exam journey. There’s plenty more to that process, from creating a study group to purchasing other study materials. 

As a way to learn about a new region. 

Fundamentals of Medical Device Regulations, Fifth Edition is split into three sections – one for US regulations, one for EU regulations and one for international regulations. Each section contains both the latest updates to keep your knowledge current and the history of medical device regulations in that area. 

How did RAPS create this book? 

Just as any new regulation takes a long road from proposal to application, RAPS’ Fundamentals of Medical Device Regulations, Fifth Edition went through 16 months of development, with authors writing and rewriting each of the 27 new chapters. 

“For most of our authors, it is a labor of love,” says RAPS Senior Editor Gloria Hall. “However, writing a chapter is a lot of work and requires many hours.” 

Thirty-eight authors contributed to this new edition, with global authors from the US, UK, Canada, Netherlands, China, Singapore, and Taiwan. 

“It was my sincere pleasure to work on this book with this dedicated, distinguished group of authors,” Hall writes in the book’s foreword, “and it is my hope that Fundamentals of Medical Device Regulations becomes your go to resource for everything related to medical devices and IVDs.” 

Fundamentals of Medical Devices, Fifth Edition is available now. 

The book is available for purchase now at $295 for RAPS members and $395 for nonmembers.


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