Decision tree
Heading
Active devices
Body
If your device is also active, you will need to continue below to check whether this results in a higher classification.
What is an active medical device?
An active medical device is one that is intended by the manufacturer to:
- depend for its operation on a source of electrical energy or other source of energy (other than a source of energy generated directly by a human being or gravity), and
- act by converting this energy.
Active medical devices do not include medical devices that are intended by the manufacturer to transmit energy, a substance, or any other element between an active medical device and a human being without any significant change in the energy, substance or other element being transmitted.
Software that is a medical device is an active medical device.
Question
Based on the above, is your device also active?
Answers