Software as a NON-medical device

hi community!
Apologies if this has been discussed elsewhere; I could not retrieve any relevant threads.
I'm looking for some guidance on labeling requirements for software as a NON-medical device. Can anyone help? Thks!

I'm a little confused. I'm assuming because you posted in this forum that the software is medical device-adjacent, even if the software itself isn't used in the medical device.

Are you talking about:
-Software that would be used in the manufacture / control / distribution of medical devices (even if it doesn't end up in the finished product)?
-Software that might be used within the medical device community, but not in a way that would directly touch a patient or product?
-Software that has no relationship to medical devices whatsoever?

hi! thank you for your time, you are right more info was needed.

I think we fall under your option 2 - software that might be used within the medical device community, but not in a way that would directly touch a patient or product?

Would software or an app in smartphones used to monitor vitals fall under this category?
I mean how do you regulate "software intended for life-style and well-being purposes" when used in a healthcare setting when it is not a medical device?

ACC. to MDR 2017/745

(19)
It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.


Plus, since I'm completely new on this, do you have any suggestions on where to look for the basics, e.g. where to look for examples on your 3 examples and how they are regulated?
thanks again. All insight is much appreciated

bill.Kal said:

... used to monitor vitals ...

Click to expand...

This is without a doubt a medical device.

MDR Article 2 (1):
‘medical device’ means any [...] software [...] 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,
[...]

Or, to put it in other words: It depends mainly on the intended purpose that the manufacturer defines. And this includes all claims made ("healthier life"). There is a grey area between MD and lifestyle, so the labelling will have to be regarded closely. An unchecked marketing department can turn your lifestyle product into a medical device, which you then sell without certification.

thank you so much for the feedback.

Do you happen to know how "software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device" is regulated?
I must work on a comparison of requirements, i.e. what we will need if (based on the intended purpose) it is a medical device and what if it is not.
Thank you again for the insight.

ACC. to MDR 2017/745

(19)
It is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, qualifies as a medical device, while software for general purposes, even when used in a healthcare setting, or software intended for life-style and well-being purposes is not a medical device. The qualification of software, either as a device or an accessory, is independent of the software's location or the type of interconnection between the software and a device.

The line between Apple Watch and medical device is not extremely well defined right now. There are guidance documents and suggestions, but as Raisin picker points out, it mostly relies on what claims you're making about your device. If you're saying, "here's some helpful information you can use to be healthier," you're probably not a medical device. If you make any kind of specific health claims, you're probably a medical device.

For a comparison point, think about a meat thermometer. It does most of what a thermometer you might use to take your temperature does, but it doesn't make any claims about being able to accurately take a medically accurate temperature. Whereas even a $5 thermometer you by at a pharmacy is required to have data that it works within a specific range at a specific accuracy with controlled labelling, backed up by a functioning Quality Management system, etc.

What are examples of Software as a Medical Device?

General Wellness: Policy for Low Risk Devices - Guidance

oh guys, this is very useful, I think I'm starting to see the thin line between.

So, if it turns up it is NOT medical device, I do not need to CE mark it under MDR and I do not need any labels ACC. to GSPR 23 right? What regulation should I check then for EUrope? sth for general commercial products?

Unfortunately, I'm most familiar with ISO 13485 as the EU med device regulation and ISO 9001 for general manufacturing. I don't have much experience with non-med device EU regulation. Perhaps someone else knows where to look?

I do know the CE mark is not med-device specific, though.

CE marking

The intended use of the device determines if the product is a medical device as defined according FDA or MDR regulations.

Non-Product System Software (NPSS): Software used to automate any part of the device production process or any part of the quality system, including design controls. Typically GxP environment.

There are different categories of these software products according to GAMP-5. Configured, Non-Configured, Off-The-Shelf (OTS) etc

In general, requirements for commercializing these products including labeling is scalable according to system complexity.

Read GAMP-5 standard

I can't recommend referring to GAMP 5 for any sort of product. As noted above, GAMP 5 is a recommended process for validating software used in manufacturing processes. It can be adapted for other uses, but it really wouldn't be as much help as suggesting something more targeted to development. Besides, GAMP 5 is expensive. I'm guessing a copy of 62304 can be legally purchased at one-tenth the cost of GAMP 5.

If the software isn't a medical device, European regulators a probably going to be more interested in Cybersecurity and Personal Data Privacy issues than anything else.