Active Implantable Medical Devices

The European Directive 90/385/EEC on active implantable medical devices of the Council of 20 June 1990.

The European Directive 90/385/EEC on Active Implantable Medical Devices (AIMD), subsequently amended by the Directive 93/68/EEC, and the relevant requirements for CE marking for such products 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 or injury;
- investigation, replacement or modification of the anatomy or of a physiological process or;
- control of conception,

and which does not achieve its principle intended action by pharmacological, chemical or metabolic means, but which may be assisted in its function by such means.