Chapter 18. European Regulation of Medical Devices
- John P Griffin BSc, PhD, MBBS, FRCP, FRCPath, FFPM1,
- John O'Grady MD, FRCP, FFPM, FBIRA, MRCPath2
Published Online: 25 OCT 2007
DOI: 10.1002/9780470987391.ch18
© 2006 by Blackwell Publishing Ltd.
Book Title
The Textbook of Pharmaceutical Medicine, Fifth Edition
Additional Information
How to Cite
Hodges, C. J. (2007) European Regulation of Medical Devices, in The Textbook of Pharmaceutical Medicine, Fifth Edition (eds J. P. Griffin and J. O'Grady), Blackwell Publishing Ltd, Oxford, UK. doi: 10.1002/9780470987391.ch18
Editor Information
- 1
Director, Asklepieion Consultancy Ltd., Visiting Professor, University of Surrey Postgraduate Medical School, Former Director, Association of the British Pharmaceutical Industry, London, Formerly Professional Head of the Medicines Division, DHSS, London
- 2
Visiting Professor of Clinical Pharmacology, University of London
Publication History
- Published Online: 25 OCT 2007
- Published Print: 15 DEC 2005
ISBN Information
Print ISBN: 9780727918406
Online ISBN: 9780470987391
- Summary
- Chapter
- References
Keywords:
- medical devices;
- european economic area;
- medical devices directive;
- drug-device combinations;
- product safety
Summary
This chapter contains sections titled:
Introduction
Law on Specific Devices
Resolution of Uncertainties
Competent Authorities and Notified Bodies
What is an MD
Classification of Devices
Conformity Assessment Procedures and CE Marking
Clinical Investigation
Adverse Event Reporting: Vigilance
General Product Safety Directive