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The Medical Devices Directive (MDD) 93/42/EEC

 

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 :

  • diagnosis, prevention, monitoring, treatment or alleviation of disease,
  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury,
  • investigation, replacement, modification, or support of the anatomy or of a physiological process,
  • supporting or sustaining life,
  • control of conception,
  • disinfection of medical devices,
  • providing information for medical purposes by means of in vitro examination of specimens derived from the human body,

Polmed-4

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.”

Classification:

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

important notice

All Class I devices must be registered with the Competent Authority where your EC Authorized Representative is based.

 

 

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