European medical device regulatory law and product liability.

  title={European medical device regulatory law and product liability.},
  author={John Bright},
  journal={The Journal of hospital infection},
  volume={43 Suppl},
  • John Bright
  • Published 1999 in The Journal of hospital infection
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… CONTINUE READING