Medical Device including a smartphone - CE mark ?

A

Armand25370

Registered
Hello,

My company is designing a medical device including a standard smartphone.
On this smartphone we have our own app. This smartphone send data and is power supplying a external hardware including a microcontroller.

My question is:

If the medical device is including the smartphone, the smartphone is losing its CE mark ? If yes, we need to have all technical documents and information regarding the smartphone to get the CE for our whole medical device ?

Another way, if its easier, is to sell the smartphone as an accessory? In this condition, do we keep the CE mark on the smartphone ?

Thanks for your clarification,
 
ChrisM

ChrisM

Quite Involved in Discussions
Is the smartphone modified in any way, or is it a "standard" product on which you simply install your app?
 
A

Armand25370

Registered
We are installing a custom android version on it as well as our app. The custom android version is used to disable certain feature.
 
Y

yodon

Leader
Super Moderator
Interesting question (I think). If I understand, you're delivering, as part of the system, an android-based phone in which you've modified the standard OS installed? If that's the case, I'm guessing you have to submit the system for CE marking (i.e., you're not just delivering a SaMD device). You may be able to show why your changes to the OS don't affect CE marking. Probably worth a discussion with your NB.
 
A

Armand25370

Registered
Yes it's exactly this. So If I understand correctly we need to be able to justify that the modificiation of the OS doen't affect the CE marking of the smartphone. After this, we have to obtain the CE marking for the full system including the smartphone. However as the smartphone is legally protected by it's owner (black box), how do we deal with the technical documentation related to the smartphone itself ? But yes, maybe we have to ask directly our NB in order to understand better the process. Thanks
 
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