How to ensure CE for stand-alone software upgrades for a combined HW/SW system

Berto_gi

Starting to get Involved
Do I understand correctly that the TF for your hardware and software
system has already been audited by NB? Have you classified software separately using rule 11? Or you have classified the software and hardware system as a whole, not just software classified under separate rule? Or have you classified ME and software separately (for example, applying rule 10 and rule 11 for class 2a within one TF for the system)? And what have you stated in the DoC project - correspondence to one or several rules?
Yes, the TF has been audited. The software and hardware are classified separately too with rule 10 and rule 11. In the end the higher class was used for the complete system with reference to the rule that determined the higher class in the DoC. However the classification document is part of the technical file.
 

Cloud808

Starting to get Involved
In relation to this thread, I saw that "MDCG 2023-4 - Medical Device Software (MDSW) - Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components" was published today.

I am unable to post links yet - apologies.

Hopefully this may lend some insight
 

Berto_gi

Starting to get Involved
Thanks for all of your support here - I would like to inform you that after discussing with our Notified Body and with the help of the guidance document, we decided to go for a two medical device solution. Hardware as a medical device and software as a medical device. An acceptable outcome which will allow be compliant.
 
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