Medical Device Directive, MDD (93/42/EEC)

The new amended Directive 2007/47/EC which, will become mandatory on 21 March 2010, explains a Medical Device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for:

  • Diagnostic and/or therapeutic purposes and 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, diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
  • Investigation, replacement or modification of the anatomy or of a physiological process,
  • Control of conception, and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted by such means

The following Toiletry and Cosmetics Products can be considered as Medical Devices if a medical claim is being made by the manufacturer for the device, although these products are not fallen under Medical Device Directive.

  • Tooth brushes, dental sticks, dental floss, dental chewing gums
  • Baby nappies, hygiene tampons, mattress protectors
  • Contact lenses intended to provide colour to the eyes
  • Instruments for tattooing.
  • Deodorants for use with devices.
  • Wigs.

The medical Device Directive the product falls under varies categories like:

  • Sterile Medical Devices
  • Non Sterile Medical Devices
  • Electro Medical Devices
  • Electro Mechanical Devices
  • Animal Origin Devices.

CE Marking for some of the categories is complicated; a well experienced consulting team is required for supporting till the certification audit by Notified Body. Any clarification or service request please contact us.

Read more about process of CE Marking.

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