ABSTRACT
Each of the European countries had developed its own form of medical device legislation, and these forms were very different. As an illustration, the position in the major EC countries in the early 1990s is briefly described.
The United Kingdom had developed a unique form of medical device regulation based not on legislation but on the administrative provisions of the National Health Service. Health care provision outside the NHS was regarded as negligible and control of medical devices used in the NHS was seen as adequately protecting the public health.
