Charles, tune in to http://medgroup.biz/New-CE-Marking-Rules, a free webinar we're hosting for group members on October 6. There will be Q&A at the end.

Marcus Gould Hi Charles

Your question says you want to change the name of the same device but for another use. This suggests you are changing the intended use which will now take it outside the scope of its original CE mark. This means you will need to submit an application for a new CE mark with the new intended use. Have I interpreted your question correctly. Please can you clarify a little further as this will affect the rules, cost and time significantly.

Thanks,

Marcus

Charles,

If you were just changing the name, that would be a simple change notification to your Notified Body, with minimal time and cost. However, with your note on "another use", I agree with Marcus that you will likely need a new application. Unless the new use falls within the original intended purpose of the device as stated on your certificate and supported by your application, you will need to provide additional data on use in the new indication.

Charles CALLEJA Hi!
Thanks a lot for your feed back. The medical device would have another use but it still falls into the original intented purpose. Any guidelines for the new brand I can propose? I would like to segment my market with a complete different name for another market, even if it is the very same product and final purpose. I will then make proposition to the Notified Body that are relevant.
Thank you very much!

Ee Bin Liew If your intended use statement has changed as a result then you'd have to consider for a new CE mark, and with new product name/branding - it's essentially a new product, for the other market. Just that physically it could be the same product. when compiling your submission package do ensure your documentation is aligned to the new name/brand.

Cheers,
Ee Bin