Is your device an active device and intended for controlling, monitoring or directly influencing the performance of active implantable devices?

 
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An 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.

Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physio­ logical conditions, states of health, illnesses or congenital deformities.

Is your device an active device and intended to control or monitor the performance of active therapeutic class IIb devices, or intended directly to influence the performance of such devices ?

 
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An 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.

Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physio­ logical conditions, states of health, illnesses or congenital deformities.

 

Is your device an active device and intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance?

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Ionizing radiation (ionising radiation) is radiation, traveling as a particle or electromagnetic wave, that carries sufficient energy to detach electrons from atoms 

or molecules, thereby ionizing an atom or a molecule.

 

Is your device an active therapeutic device intended to administer or exchange energy?

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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.

 

Is the devices characteristics such that it may administer energy to or exchange energy with the human body in a potentially hazardous way, taking account of the nature, the density and site of application of the energy?

Is your active device intended to emit ionizing radiation for therapeutic purposes, including devices which control or monitor such devices, or which directly influence their performance?

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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.