CE Marking: Date of Manufacture or Date of Shipment

[Asherlee]

We assemble/manufacture a Class IIa medical device for a company in USA that sells the device in Europe. The USA company had ISO 13485 and CE approval via a NB. As from May, 2009, the USA company no longer has ISO 13485 and CE approval via a NB, and the NB has informed them that as from May, 2009, they are not allowed to sell devices with the CE number of the NB in Europe.

Question: we manufactured devices for the USA company in April, 2009 and added the CE number of the NB to the devices. We will only ship these devices AFTER May.

Do we need to remove the CE number of the NB from the device? i.e. which is the date that determines whether CE marking can appear on the device - the date of manufacture or the date of shipment?

Thanks.

Asherlee

 

[MIREGMGR]

My understanding would be that your customer is not allowed to ship product with the CE Mark, and by derogation with the NB's identifier, after May.

Your manufacturing and shipping dates are irrelevant. As a contract manufacturer, your role is transparent to your (ex- ?) customer's regulatory relationship to the EU via the NB intermediary.

If/when you ship further units to your customer...possibly after re-labeling them without the CE Mark...what will your customer do with them?

Regarding the general situation: yikes. You have my sympathies.