How to classify this computer-alike IT device

[LievenDW]

The device is a computer-alike IT product, certified to IEC60950. It is brought on the market with factory-installed software with medical device functionality.

How would you categorize this product? Is the complete product a medical device because of the software functionality? Yet it is not certified to the medical harmonized standards. Or is the software a medical device on its own? Yet it is embedded, and hence is not a standalone software....

You see, I'm puzzled. Would appreciate some good ideas.

 

[Ronen E]

The device is a computer-alike IT product, certified to IEC60950. It is brought on the market with factory-installed software with medical device functionality.

How would you categorize this product? Is the complete product a medical device because of the software functionality? Yet it is not certified to the medical harmonized standards. Or is the software a medical device on its own? Yet it is embedded, and hence is not a standalone software....

You see, I'm puzzled. Would appreciate some good ideas.

Upfront, it’s quite hard to say while knowing so little about this product. But I’ll give it a go.

What makes this product different from an “ordinary” computer? Are there hardware differences?

Can the software be removed by the user, or are there reasonable safeguards against it?

Can other software be installed and used on the “computer”, or are there reasonable safeguards against it?

If the answers are “no” and “no” (ie they can’t), I think that it’s a truly integrated device; the software is not stand-alone; and if indeed the use meets the medical device definition, the device (hardware+software) as a whole has to comply, perhaps meet IEC 60601.

Otherwise this can be seen as a “system” - 2 separate products sold together and meant to be used together; or, in the extreme, as two separate products, where one might be considered a medical device and the other not (I suppose in that case the software should be treated as stand alone, and it already being installed considered a matter of convenience / good service).

But again, it’s hard to tell without seeing much of it (I’m happy to receive a PM if you’re concerned about confidentiality).

Cheers,
Ronen.

 

[LievenDW]

Thanks a lot Ronen. I think the system approach is a good way to look at this product.

Kind regards
Lieven