Commercializing a non medical device software

Hello, we are manufacturer and editor of class I software that will have to be in class IIa according to the regulation.
We are working on 2 projects with rehabilitation centers and hospitals, and we would like to declare that the software under development is not a medical device, because it does not trigger any alert and is used to collect and display the patient's vital parameters.
In your opinion, how can it be declared a diagnostic tool but not a medical device?
Thank you for your help,

Bump.....Can anyone help?

Which market will it be sold in? Does it diagnose, treat or monitor a health condition?

Ed Panek said:

Which market will it be sold in? Does it diagnose, treat or monitor a health condition?

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Hello, first of all thank you for your feedback,
1- The software will be sold in Europe.
2- It allows to collect data and control the physical condition of post-hospitalized patients.

2- It allows to collect data and control the physical condition of post-hospitalized patients.

For whom and why?

From the MDR
Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

Ed Panek said:

2- It allows to collect data and control the physical condition of post-hospitalized patients.

For whom and why?

From the MDR
Article 2 Definitions For the purposes of this Regulation, the following definitions apply: (1) ‘medical device’ means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:
— diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
— diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
— investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
— providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations, and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.

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Patients do sports sessions in a rehabilitation center, so our software is used to collect and display patient data to the rehabbers for each sports session.
They see their evolution over time.

Its still not clear to me.

On your products promotion page "Where customers see it" prior to purchase how do you describe it to be used. Why is your software better than other options? In other words, what claims do you make to customers about it?

iam1235 said:

how can it be declared a diagnostic tool but not a medical device?

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Diagnosis is the first medical purpose listed in the definition of a medical device, so it's very likely to be a device.

You do mention "under development" so its use may not require CE marking yet, but could be considered to be a Clinical Investigation.

dgrainger said:

Diagnosis is the first medical purpose listed in the definition of a medical device, so it's very likely to be a device.

You do mention "under development" so its use may not require CE marking yet, but could be considered to be a Clinical Investigation.

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Thank you for your reply,
The software we plan to sell soon collects the patient's data (like heart rate...) and displays it to the sports doctors who will use it in the sessions with their patients.
So the software only collects and displays the data. No alert is sent back

If a physician is using it in any manner to impact his treatment it would appear to be a medical device. It depends on what "Collects" means