Software as a Medical Device (SaMD) Technical File Requirements

[Fat Larry]

Our company makes medical stimulation devices which contain software integral part. We are now developing a device which can be controlled by the user’s mobile phone instead of the usual remoted control. In future the user will be able to download stimulation treatment software programs targeting specific medical conditions from the AppStore. My understanding is that this will classify it as “stand alone software” and Software as a Medical Device (SaMD). My question is how to CE mark the software? Should it be CE marked in the same Technical File as the device it’s intended to be used with or should it have its own Technical File?

 

[yodon]

Per the IMDRF's definition of SaMD:

Software does not meet the definition of SaMD if its intended purpose is to drive a hardware medical device.

So, are you sure it's SaMD? On the surface, it would seem more of an accessory. If you develop under 62304, you'll at least have the necessary materials, either way.

 

[chrische129]

Hello Everyone,
I am working on the EU-MDR submission for SaMD. This is my first time. Thank you, all so much for your experience. You all have guided me to some degree. Can someone help me to obtain a completed and approved EU-MDR submission for SaMD? I want to view what the submission looks like. This is definitely a journey and a good learning experience. Thank you so much.

 

[shubad]

I am in the process of writing Tech file for an software accessory. And we've decided to keep the accessory TF separate from the device TF. We want to follow the same format of TF as device i.e, STED Format. I am confused on what to put for general description of product, it's Principle of Operation etc. (Things that make sense of hardware device but not for software device.??)

 

[Mahen]

Hello Everyone,
I am working on the EU-MDR submission for SaMD. This is my first time. Thank you, all so much for your experience. You all have guided me to some degree. Can someone help me to obtain a completed and approved EU-MDR submission for SaMD? I want to view what the submission looks like. This is definitely a journey and a good learning experience. Thank you so much.

 

[Mahen]

Hi Chrische129

Did you get any help on ur request please. I need the same help

 

[Hi_Its_Matt]

@Mahen You are incredibly unlikely to find online or be given access to a real EU MDR submission, given their confidential nature. A quick google search of "EU MDR software as a medical device" and "EU MDR submission content" provides two resources you may find useful. Beyond this, I would advise engaging your notified body to see if they have guidance on submission content.

BSI Group - Best Practices Guidelines - MDR Documentation Submissions (Rev 2, May 2020)
Med-Tech blog post - Software as a Medical Device - Demystifying EU MDR