Is it an active therapeutic device with an integrated or incorporated diagnostic function which significantly determines the patient management by the device (such as closed loop systems or automated external defibrillators)?
Active device means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
Software shall also be deemed to be an active device.
Therapeutic means of or relating to the treatment of disease or disorders by remedial agents or methods.
EXAMPLES
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Automated external defibrillators (AED) including their pads/electrodes
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Semiautomatic external defibrillators
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Automated closed loop insulin delivery system
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Automated external infusion pumps with integrated sensors to adapt the infusion therapy
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Devices in brain-computer interfaces (BCIs) – used for e.g. motor control in severely paralyzed patients
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Closed-loop systems for deep brain stimulation (DBS) treatment of various neurological conditions
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Closed-loop dynamic neurochemical control of therapeutic interventions e.g. target-controlled anaesthesia / infusion systems