If a piece of software receives approval as part of a medical device system

[snoopy2017]

Hello,
Thanks so much for everyone's help. This has been a very helpful forum. If a piece of software receives approval as part of a system, is it possible to market the software as a standalone medical device or does this piece of software require a separate licence?

Thank you again for all your help.

 

[shimonv]

An interesting question. Does your Health Canada license clearly identifies the software with its identification number?
If so, there is a pretty good chance that you don't need a separate license to sell it as a standalone piece. You do need to verify that no software modifications are required, the Intended Use remains the same, and what is the impact on the instructions for use and risk analysis.

Shimon

 

[yodon]

I would seriously doubt it since, as you said, the original software is part of a system and it's the system that was cleared. All of your V&V work would have been on the system - which happened to contain the software. If you market stand-alone software, you have broader considerations regarding the host platform.

 

[shimonv]

Yodon,
I agree with you and that's why my response was not definite. Take for example a DICOM image viewer; such a piece of software can be sold independently so long as the host computer maintains the minimum requirement.

This case might be a lot more complicated and so a number of things have to be checked, like V&V, IFU and Risk Analysis.

snoopy2017 - I hope you got the general idea.

Thanks Yodon.


-Shimon

 

[Mark Meer]

...If a piece of software receives approval as part of a system, is it possible to market the software as a standalone medical device or does this piece of software require a separate licence?...

One thing you'll definitely have to document is: What is the risk of installing on uncontrolled hardware?

If we're talking consumer computers, then a host may meet the minimal requirements hardware-wise (CPU, memory, OS version....), but ALSO have issues (e.g. malware) that are outside of your control and may affect the function/reliability of the software.

Also, was the software previously pre-installed (on whatever hardware came with the system)? If so, you'll have to have installation instructions, clearly specify minimum requirements, and assess risk of improper installation, or system conflicts.

I'm not certain if such changes qualify for a new license, as you'd presumably have new evidence to present (new packaging, new labeling, usability of installation process...).

 

[snoopy2017]

Thanks everyone for your thoughtful responses.