Active Implantable Directive, (90/383/EEC)

The definition of Active medical device - 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 definition of Active implantable medical device - 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;

The requirements for devices within the scope of the Directive are essentially the same as for devices classified as class III under the Medical Devices Directive. These include essential safety requirements in terms of function, sterility, and material compatibility, labeling instructions, design documentation along with type approval, production quality management and clinical investigation.

Few examples for such type of devices are the following:

  • Implantable active drug administration device
  • Implantable active monitoring devices
  • Implantable cardiac pacemakers
  • Implantable defibrillators
  • Implantable nerve stimulators
  • Bladder stimulators
  • Sphincter stimulators
  • Diaphragm stimulators
  • Cochlear implants
  • Programmers, software, transmitters

CE Marking under this directive is very difficult to get through a Notified Body. Normally to complete such a project manufactures had to work hard for more than 9 months. Readers can use our experience and knowledge for successful completion.

Any clarification or service request please contact us.

Read more about process of CE Marking.

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