Change of Name to a CE Marked Product

[ISO 13485 - Medical]

My company distributes medical device products in the EU (we are based in the EU) and we want to distribute another medical device but under another name from what the company has on the CE Certificate (class 2 product).

The name of the product will be changing but the manufacture is not and it will be made just for distribution by my company.

Is there anything we need to do as a distributor?

 

[MIREGMGR]

So the CE Mark on the new product will be that of the actual manufacturer, not yours?

 

[ISO 13485 - Medical]

So the CE Mark on the new product will be that of the actual manufacturer, not yours?

Yes we will only be distributing the product but the name is changing from from what was on the CE Mark certificate

 

[ScottK]

Is the part being modified in any way? Labeled with the new name perhaps?

 

[somashekar]

Yes we will only be distributing the product but the name is changing from from what was on the CE Mark certificate

The Ref number on the label must have the same details as on the CE cert as well as the manufacturer's address. Your changed name and / or code can then appear on the label for your distribution requirements, and your address alongwith it if necessary. Let the manufacturer add this new label detail also into his technical file. The CE mark along with the NB number will also appear on the label as in the manufacturer's technical file.
If your manufacturer is outside of the EU, then his AR's name and address must also appear on the label. You need to just do your business activites in your normal way once such an label is released to the product that he sells to you to distribute in the EU.

 

[ISO 13485 - Medical]

Is the part being modified in any way? Labeled with the new name perhaps?

The product is not changing, but the label will change with the new marketing name

 

[ISO 13485 - Medical]

The Ref number on the label must have the same details as on the CE cert as well as the manufacturer's address. Your changed name and / or code can then appear on the label for your distribution requirements, and your address alongwith it if necessary. Let the manufacturer add this new label detail also into his technical file. The CE mark along with the NB number will also appear on the label as in the manufacturer's technical file.
If your manufacturer is outside of the EU, then his AR's name and address must also appear on the label. You need to just do your business activites in your normal way once such an label is released to the product that he sells to you to distribute in the EU.

Thanks for the help

The only change on the label will be the name of the product.

Will the manufacturer have to issue a new Declaration of Conformity?

Will the manufacturer have to notify there notified body?

 

[somashekar]

Will the manufacturer have to issue a new Declaration of Conformity?

Will the manufacturer have to notify there notified body?

This does not call for any new DOC
A new label with your details will be held within the manufacturer's technical construction file (TCF). At this stage he has to make an assessment if this addition is a significant change. If so he has to notify the NB.
I would not catagorize this as a significant change.

 

[ISO 13485 - Medical]

This does not call for any new DOC
A new label with your details will be held within the manufacturer's technical construction file (TCF). At this stage he has to make an assessment if this addition is a significant change. If so he has to notify the NB.
I would not catagorize this as a significant change.

Once again thanks this is very helpful.

Would the process be the same for the US and the FDA or will this be different due to the device trade name being register?

 

[MIREGMGR]

Would the process be the same for the US and the FDA or will this be different due to the device trade name being register?

What is the device's FDA classification? In many instances, there is no parallelism between MDD and FDA classifications.

If the device is FDA Class II, does the Manufacturer hold a 510(k) for it?

If yes, then selling the device under a different brand or trade name is irrelevant to its regulatory status. The Manufacturer simply would keep records of the product variants offered to the market, and the labeling used on them.

The FDA permits private-label versions of device products to carry only the name and contact information of their distributor, so long as the end user can obtain contact information for the Manufacturer from that distributor in the event that an adverse incident is to be reported.