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European medical device regulatory law and product liability

Authors
Journal
Journal of Hospital Infection
0195-6701
Publisher
Elsevier
Publication Date
Volume
43
Identifiers
DOI: 10.1016/s0195-6701(99)90083-x
Keywords
  • Risk Assessment: A Medico-Legal View
Disciplines
  • Communication
  • Medicine
  • Pharmacology

Abstract

Abstract The regulatory system for medical devices is quite different from that for pharmaceuticals and may catch many people unawares. For instance, it does not involve the grant of a marketing authorization by a medicines agency. Instead, a ‘ declaration of conformity’ is made by the manufacturer, but in many instances this is subject to approval by an independent certification house (known as a notified body). The Medical Devices Directive 93/42/EEC is applied in each EEA State by national Legislation. In the UK, for example, the relevant law is the Medical Devices Regulations 1994, and responsibility for enforcement rests with the Medical Devices Agency. Non-compliance with the regulations can incur a criminal penalty.

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