A new model for European medical device registration. A comparative legal analysis in the EU and the USA

Book abstract:

Over 400,000 types of medical devices are in use each day. Each one is designed to provide better health care but is also a potentially harmful weapon. Unsafe medical devices can cause harm to the health of individuals, so it is important that the innovation which prompts their design should be controlled to ensure safety. This book analyses the regulation of medical devices at the federal level in the United States and in the European Union.

The volume is organised over seven chapters. The introductory chapter provides background and an outline to the book. Chapters two and three offer an analysis of the regulatory framework for medical devices in the European Community and go on to explain why there is a need to restructure the Community medical device framework from an institutional point of view. Chapter four offers a model to achieve the latter. Chapters five and six illustrate the US position on medical device regulation both from a substantive and institutional point of view. This is offered for comparison purposes. The final chapter outlines why it is necessary to amend the regulation of medical devices in the EU, and how the restructuring of the medical device regime can be achieved.

The work will interest practitioners, policy researchers, policy makers engaged in regulatory issues.