A
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
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