Medical Devices means :
“any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of :
|and which does achieve its primary 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.”|
The Medical Devices Directive (93/42/EEC) applies different administrative requirements to devices
depending on the risk which they present to the user.
There are four classifications:
- Class I - generally regarded as low risk
- Class I Measuring
- Class I Sterile
- Class IIa - generally regarded as medium risk
- Class IIb - generally regarded as medium risk
- Class III - generally regarded as high risk
All Class I devices must be registered with the Competent Authority where your EC Authorized Representative is based.