Middleware used in SaMD

Hi All,
If a company develops a software medical device and is using a middleware that was developed by the company as well for different software products developed by the company (and not 'off- the-shelf' software) - is the middleware used in the software product considered a medical device as well? Should it have all relevant technical file documentation separately from the SaMD?

Many thanks in advance!

From your description, it sounds like the middleware would be a "software item" (IEC 62304) in your medical device software system. You would manage it as such, with relevant technical file documentation. If you follow IEC 62304 (highly recommended), you can establish the appropriate safety class for it which, in turn, defines the documentation requirements. It would not be a medical device in and of itself since it doesn't do anything outside the scope of your system.

Agree with Yodon. Depending on how you describe it and use it. I would personally just say yes to prevent any issues. A good idea in QMS decisions is if you are struggling your self with a definition and need to choose a path choose the more conservative one.

Thanks so much @yodon and @Ed Panek . Will follow your advice