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Brief Introduction of Directive 93/42/EEC Medical Devices


Directive 93/42/EEC Medical Devices

  1. A Medical Device is defined in Directive (93/42/EEC) as: Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
    • diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
    • investigation, replacement or modification of the anatomy or of a physiological process.
    • control of conception
  2. The following products are excluded from the scope of the Directive:
    • In vitro diagnostic devices
    • Active implantable devices covered by Directive 90/385/EEC
    • Medicinal products covered by Directive 65/65/EEC
    • Cosmetic products covered by Directive 76/768/EEC
    • Personal protective equipment covered by Directive 89/686/EEC
    • Tissues or cells of human origin
    • Viable tissue or cells of animal origin

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