Medical Device

This refers to any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination with the software necessary for its proper application intended by the manufacturer, which is to be used on persons for the purpose of:

  • diagnosis, prevention, monitoring, treatment or alleviation of diseases
  • diagnosis, monitoring, treatment, allevation of or compensation for any injury or handicap
  • examination, replacement or modification of the anatomy or of a psychological process
  • control of contraception

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

Tens of thousands of medical devices reflect the wide range of medical technology. These products are generally divided into two groups: active medical devices and non – active medical devices.

The distinguishing criteria can be found in the classification rules Medical Device Directive 93/42/EEC about medical devices. MEDCERT is accredited for the examination and certification of almost all medical devices, except for a few large medical devices. MEDCERT offers you professional know-how and experience as a basis for evaluation and certification of medical devices – even of highly complex and innovative equipment. According to the classification rules, the medical devices are classified into four risk classes: I, IIa, IIb und III (depending on the risk in the application).

Further to this, there are subclasses Is (for sterile class I products) and Im (class I products with a measuring function). The rules of classification are defined in Annex IX of the Medical Device Directive 93/42/EEC. The application of classification rules depends on the intended use of the products and therefore the manufacturer bears the whole responsibility for this.

 

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