Medical Devices (active/non-active)

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The 93/42/EEC European Medical Devices Directive (MDD) and the relevant requirements for CE marking for medical devices has been published in the Official Journal of the European Communities. The Law on Medical Services (MPG) incorporates the 93/42/EEC Medical Devices Directive, the 90/385/EEC Directive on active implantable medical devices and 98/79/EC Directive on in vitro diagnostic medical devices into national law.

In accordance with Article 1, Paragraph 2a of the MDD, the following definitions shall apply:

Medical device: means any instrument, apparatus, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

• diagnosis, prevention, monitoring, treatment or alleviation of disease;
• diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap;
• investigation, replacement or modification of the anatomy or of a physiological process;
• control of conception,

and which does not achieve its principle intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.

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