Product name change - is this considered as a significant change under EU MDR?

Hello

I was reviewing the MDCG 2020-3 guidance to assess the change impact on the device name.
Our device is a legacy device under MDD and it is preparing for MDR transition.

We would like to change the name of the device but MDCG guidance has an example of name change of manufacturer, not the product itself.

Is this product name change considered a significant change? And if we are in transitioni to MDR (not certified yet), is this change not allowed?

I don't think so, but you should ask your notified body to be sure.

I dont think so. In this case your NB probably considers this akin to you making a private label version for your distributor.

it depends. if you change the tradename, it's not significant, but may affect the product certificate, if any. if change the generic name or charateristics wording, this would lead to the concerns on intended claims change.

Hi everyone, reviving this thread for a sec...

Ed Panek said:

I dont think so. In this case your NB probably considers this akin to you making a private label version for your distributor.

Click to expand...

I also think new private labels are not considered a significant change. However, would it then be possible to update the DoC in order to include the new private labels (with their own internal product reference codes)? Is it possible to modify the DoC of a legacy device?

Does anyone have experience with that?

Our NB requires that all product names and trademarks are listed in the CE certificate (MDR, but it was the same with MDD). So, I cannot change a name or add a new one without informing them, at least because I need that my CE certificate is extended to the new name (this is quite annoying and expensive, of course). The same is for new trademarks. And our DoC should reflect the content of the CE certificate.