Class IIa Medical Device - Can I over label to change an address?

J1980b

Starting to get Involved
#1
Hi,

I need to change the address on the artwork of a Class IIa product. Is there any regulation that prevents me putting a printed label over the top of the orginal name/address?

Thanks in advance
 
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somashekar

Staff member
Super Moderator
#2
Hi,

I need to change the address on the artwork of a Class IIa product. Is there any regulation that prevents me putting a printed label over the top of the orginal name/address?

Thanks in advance
If you need to change the address, do you have a CE certificate having the new address already ?
 

J1980b

Starting to get Involved
#3
Hi,

Yes the CE certificate will be issued with th enew address. The purpose of over labelling is to use up the stock I have with the old address present
 

pkost

Trusted Information Resource
#4
There is no rule preventing it, you will need to carry out a risk assessment and demonstrate that you continue to comply with the Essential requirements, but it has been done before.

I would suggest you speak to your notified body about what they advise, this is a regular occurrence
 
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