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This ninth edition of Fundamentals of EU Regulatory Affairs focuses on the significant transformation of the healthcare product regulatory landscape in the European Union (EU), including the impact of Brexit and the European Medicines Agency’s (EMA) move from London to Amsterdam. As the new regulations for medical devices and in vitro diagnostic medical devices transition into effect over the next several years, regulatory professionals will be faced with consequential challenges. The medical device chapters in this book provide an in-depth look at these changes and explain what they will mean for manufacturers, notified bodies and competent authorities.
Two new chapters are included in this edition, covering the regulatory framework for advanced therapy medicinal products (ATMPs) in the EU and EMA meetings during review of a marketing authorisation application.