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Is your device software?

R11
Computer Programming

Note

Software, which drives a device or influences the use of a device, shall fall within the same class as the device. If this is the case then please answer "no".

 

If the software is independent of any other device, it shall be classified in its own right.

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According to MDR, software shall be deemed to be an active device.

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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.

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Is your software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes?

11.1a
therapeutic.jpeg

Therapeutic means of or relating to the treatment of disease or disorders by remedial agents or methods.

Could the impact of the decision be death or an irreversible deterioration of a person's state of health?

11.2
Doctor Operating CT Scanner

Software, which drives a device or influences the use of a device, shall fall within the same class as the device.

If the software is independent of any other device, it shall be classified in its own right.

Could the impact of the decision be a serious deterioration of a person's state of health or a surgical intervention?

11.3
Medical Tablet

Software, which drives a device or influences the use of a device, shall fall within the same class as the device.

If the software is independent of any other device, it shall be classified in its own right.

Is the software intended to monitor physiological processes?

11.4a
Amazing-d-Tech-Continuous-Glucose-Monito

Software, which drives a device or influences the use of a device, shall fall within the same class as the device.

If the software is independent of any other device, it shall be classified in its own right.

Is the software intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient?

11.4b

Software, which drives a device or influences the use of a device, shall fall within the same class as the device.

If the software is independent of any other device, it shall be classified in its own right.

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