Active Implantable 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

The "active medical device" means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity
The "active implantable medical device" means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.

Why Active Implantable 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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