The European Directive 93/42/CEE AND SUBSEQUENT AMENDMENTS

The European Directive 93/42/CEE AND SUBSEQUENT AMENDMENTS regulates medical devices, including a vast array of products. With the term medical device is meant whatever tool, device, installation, material or other product, used individually or in combination, including also the software applied for the correct employment, designed by the manufacturer in order to be used on human beings with the purpose of:

  • diagnosis, prevention, control, therapy or attenuation of a disease;
  • diagnosis, control, therapy, attenuation or neutralization of an injury or a handicap;
  • studying, substituting or modifying the anatomy or a physiological process;
  • intervening on the conception, in those circumstances where the product does not exercise the main action through pharmacological or immunological means, nor through metabolic processes, but where the used mean assists the function for which it is employed, inside or on the human body for which it is intended.

Classification of medical devices

Medical devices are grouped, according to their complexity and their potential risk for the patient, into four classes: I, IIa, IIb, III.

The classification depends on the use indicated by the manufacturer, and the classification rules are included in Attachment IX of the Directive 93/42/EEC. In order to guarantee the medical devices’ safety, the application and conformity to the essential requirements referred to in Attachment I of the Directive 93/42/EEC and following modifications and integrations, is a mandatory requisite, in order to put those products on the market. Moreover, nowadays it is a demanded prerequisite, for the purpose of entering a continuously expanding number of extra European markets.