Monitors supplied with software EU

[KhPat]

Hello,

How are monitors/tablets which are being used to upload software onto regulated according to MDD/MDR, the tablets itself are not medical devices and the labels affixed on them are from the original manufacturer as we do not alter anything other than upload the software. Its a bit confusing on why they would be considered a "device", anyone have any insight, useful resources or tips in case they have ran into a similar incident.

I tried to contact my notified body but no response yet.

 

[Billy Milly]

Do you provide software or tablet with software? If first, this is SaMD, if second, you have a medical device (tablet + software).

 

[KhPat]

Tablet with the software already installed. So the tablet + software would be considered the medical device, but what if the tablets itself have not been MDR/MDD certified?

Previously when we used to add labels onto the tablet, we were asked to remove them post an audit as the tablets were not manufactured by us.

 

[L_O_B]

That is a common issue and I see why you were asked to remove the additional label from the tablet.

I assume that the tablet is end user ready on its own. It has a CE mark (at least according to the low voltage and electromagnetic compatability directives) and is accompanied by relevant information from its manufacturer. Therefore it is a product in conformity with legislation that applies to it.
Your software is a device within the meaning of MDR article 1(4). From a regulatory perspective you must provide hardware specifications for your software to run on. Instead of just providing this information, you decided to restrict your device to only be used with a specific hardware (probably because of safety and/or convenience reasons). This restriction is not sufficient to make the tablet a medical device.
Each device is a product but not each product is a device within the meaning of MDR article 1(4).

In your scenario you have a 'device' (your software) and another product in conformity with legislation that applies to this product. You combine them to be used within a medical procedure.
In theory, I see two options here. You may apply article 22 and claim this combination to be a system. You still have to evaluate the tablet to be suitable in this context, but I expect you already did this.
The other option would be to treat the combination as a new device. In that case, the manufacturer of the tablet should be treated as an outsourced production process. You would need the whole documentation and ensure control over the production process. I do not expect this to be feasible.

 

[KhPat]

Sidetrack to another question... do devices placed on the market with HC and FDA need to be the same as EU, for example if you have 4 individual devices (software and sensors) on the FDA and HC market but for the EU you combine all these into one software and corresponding sensors is there is issue with this if necessary verification and validation is conducted?

Will distributors in the EU and other countries who ask for CE certificate have issues as currently they would have each device registered individually?

I look forward to hearing your thoughts and opinion on this. Thank You!