Change Control - Product Name Change and its associated labeling

[Deisemedev]

If you are updating the name of the product and its associated labeling as a result of the re branding process would you be required to inform the notified body?. I can't see any reference to product name changes in NBOG BPG 2014-3 or NB-MED/2.5.2/Rec 2. There is no change to the indications for use and manufacturer details.

 

[shimonv]

My advice is to make a notice to the notified body and see what they say. Better not to surprise them
I also think that if you change your product name you will need a new CE certificate for the new product name. Obviously it's not a big deal as with a new product, but you will need to provide a statement of identity and such..

Shimon

 

[Ronen E]

It's not a significant change because it's a new product...

 

[Sicco]

You need approval from your notified body for this change and also reissue of your current EC Certificate with new device name.
It is not so insignificant change as you could meant, because you are introducing a new product practically. Incorporating this change with your NB could also take up to six months according to my experience.

 

[Asia78]

You need approval from your notified body for this change and also reissue of your current EC Certificate with new device name.
It is not so insignificant change as you could meant, because you are introducing a new product practically. Incorporating this change with your NB could also take up to six months according to my experience.

But the device name is not written in the ec certificate....

 

[Sicco]

But the device name is not written in the ec certificate....

This depends on your NB common practice, it is not a rule. Some NB's issue certificates with the names of the device and from my experience most of them doing it this way.
Moreover - any local competent authority may contact your NB and asked it for device technical file documentation for evaluation.

 

[RobertvanBoxtel]

If you are updating the name of the product and its associated labeling as a result of the re branding process would you be required to inform the notified body?. I can't see any reference to product name changes in NBOG BPG 2014-3 or NB-MED/2.5.2/Rec 2. There is no change to the indications for use and manufacturer details.

Does the name change concern a branding name change? and is it still covered by the technological and clinical scope of the CE certificate Annex II? Then it is a non-significant change. However, is the device a Class III and also covered by a DE certificate (Annex II.4), it might be very well possible that the NB needs to issue a new DE certificate in the case new product codes are introduced, as DE certificates include these product codes.

 

[twanmul]

Our NB have stated that they should be notified where we are wanting to make changes to the labels on any of our (IVD) Annex II devices (though this may be due to the certificate as alluded to above).