Which classification does a Medical Device fall into?

As per the classification rule set out in Annex IX of the directive, the  medical device (MD) are classified as Class I (including Is & Im), Class IIa, IIb and III, with Class III covering the highest risk products. The higher the classification the greater the level of assessment required.

  • how long the device is intended to be in continuous use
  • whether or not the device is invasive or surgically invasive,
  • whether the device is implantable or active
  • whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.

It is usually the Intended Purpose for use in humans that determines the class of the medical device.

Read more about classification rules

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