Medical Devices

Briefly

CE Marking is most probably required if you export to the 27 European Union (EU) and 3 European Free Trade Association (EFTA) member states 20 groups of products.

Description

A "Medical Device" is defined in Directive (93/42/EEC) as: any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for the proper application, intended by the manufacturer to be used for human beings for the purpose of :
o diagnosis, prevention, monitoring, treatment or alleviation of a disease, an injury or a handicap.
o investigation, replacement or modification of the anatomy or of a physiological process.
o 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.

Why Medical Devices?
  • 1. CE Marking on a product is a manufacturer\'s declaration that the product complies with the essential requirements of the relevant European health, safety and environmental protection legislations, in practice by many of the so-called Product Directives.
  • 2. CE Marking on a product indicates to governmental officials that the product may be legally placed on the market in their country.
  • 3. CE Marking on a product ensures the free movement of the product within the EFTA & European Union (EU) single market (total 30 countries).
  • 4. CE Marking on a product permits the withdrawal of the non-conforming products by customs and enforcement/ vigilance authorities.

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