On the different kinds of devices that exist, there are active devices.
Let´s clarify which products are falling under this category:
The definition from the MDR 2017/745 Article 2 paragraph 4 says:
‘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;
So any device that works with electricity to for example run a drill (like a power tool) or to use that energy to run software is then an active device.
Sub-definitions
And under the active device definition, there are 2 more definitions to present (Annex VIII paragraph 2.4 and 2.5:
‘Active therapeutic device’ means any active device used, whether alone or in combination with other devices, to support, modify, replace or restore biological functions or structures with a view to treatment or alleviation of an illness, injury or disability.
So this is an active device that is used to really act on the patient´s disease.
And then there is the other kind of active device, which are:
‘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 physiological conditions, states of health, illnesses or congenital deformities.
In that last case, those devices are more helping you to find what is the situation of the patient. It´s not treating anything.
Why is it so important to know that?
It´s important for the classification of your medical device. This vocabulary is used on the different rules in annex VIII to find what is the class of your product.
So if your product is an active device, this can change its classification and change also all the rest for you.
As seen a Software is considered as an active device so don´t forget to look at this article to know more about SAMD (Software as a Medical Device).