OBL CE Marked Medical Device Labels

[sriramsl]

Need Help and advise from experts:
We buy full Active Medical Device from a company in China. This product is CE marked. We place the product in our market with our Brand name and our Model number. We follow the OBL route and we obtained CE marking for the product. During this process we have declared that we are the manufacturer and as such the Label is put accordingly with our company name and our factory (India) address against the Manufacturer symbol.

Now for cost reduction we want our OEM (China company) to make the Label and paste on the product and send it to us. That is the product will have the label with our company as the Manufacturer, even before the product reaches our factory.

Does this violate any EU regulatory and ISO 13485 regulations.

Your expert advise is highly appreciated

 

[amjadrana]

Re: OBL - Labels

This would not pose any problems related to ISO 13485 or CE marking, as the labelling and Packaging procedure would show the labels being used. The contractual agreement between the original manufacturer and your company would also be part of the documentation. Problem may come up at the customs. You will need to have the shipping documentation attached with the shipment.
In my previous company we had been affixing labels for the OBL company according to their requirements and they did not have any problems. But these OBL companies were located in Europe. I do not know the requirements from India.
Amjad Rana

 

[dgrainger]

Hopefully you will additionally have details of the authorised representative on the label!

 

[sriramsl]

Re: OBL - Labels

Thank you very much Mr Amjad Rana for the clarification
I was wondering from common sense perspective - how can we declare that the product is manufactured at the premises (labelling is a legal declaration) even before that product reaches the premises.
Anyway thanks and regards
Sriram

 

[sriramsl]

Yes the label carries all the regulatory requirements including the authorised representative name and address

 

[pkost]

Re: OBL - Labels

Thank you very much Mr Amjad Rana for the clarification
I was wondering from common sense perspective - how can we declare that the product is manufactured at the premises (labelling is a legal declaration) even before that product reaches the premises.
Anyway thanks and regards
Sriram

Your declaration as manufacturer is made within the directive 93/42/ec, for which a specific definition of manufacturer is provided - this definition does not require the manufacturer to be the company that actually makes the device