Software MD MDR submission

[TomQA]

Hello,

I have a question, we are commercialising an SaMD (legacy device - class I MDD, version 1.12.0 for instance) and we are currently working on the MDR submission (class IIa which we will call "version 2.0".

Once we have submitted the MDR version 2.0, it will take time to have it approved, can we still commercialised the Legacy version and make modifications (version 1.13, 1.14, etc.) as long as they are not significant changes according to article 120 of the MDR?
Once the MDR version is CE marked, we will migrate the changes of 1.13,1.14,etc. to the MDR version (version 2.1.0).
Does that make sense?
Thank you very much for your help !
(I am talking about software but this could also be applicable for hardware i guess?)

 

[Ed Panek]

If you have a valid CE cert under MDD and have applied for MDR and engaged in a contract and have made updates to your QMS for post-market surveillance You may use the MDCG guidance on significant changes to update your device. I would verify with your NB that's all in order first though.

 

[DanMann]

Hi Tom - Yes, this is exactly what my current and previous two employers are doing and I believe this is absolutely allowed. Like Ed says, the only challenge may come with the NBs change control processes and having them confirm that the non-significant changes were non-significant in their opinion (although given how busy NBs are, you probably won't get an answer from them before you get your MDR CE certificate anyway and one of my NBs confirmed that is is up to the manufacturer to tell that NB when there is a significant change and they don't review non-significant changes except for in audits) and also changing any labelling in the versions (e.g. 1.14 might not be exactly the same as 2.1.0 if the product labelling is in the software).