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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) has been subsequently amended by the Directive 93/68/EEC. The relevant requirements for CE marking for such products have 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. It includes the software necessary for its proper application intended by the manufacturer to be used for human beings for the following purposes.
- 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 for the human body but may be assisted in its function by pharmacological, chemical or metabolic means.