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Class IIa Medical Device - Can I over label to change an address?
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Class IIa Medical Device - Can I over label to change an address?
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class ii medical device, labeling requirements, labels and labeling (general), medical devices
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  Post Number #1  
Old 25th January 2012, 01:14 PM
J1980b

 
 
Total Posts: 14
Question Class IIa Medical Device - Can I over label to change an address?

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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  Post Number #2  
Old 25th January 2012, 01:53 PM
somashekar's Avatar
somashekar

 
 
Total Posts: 5,362
Re: Class IIa Medical Device - Can I over label to change an address?

Quote:
In Reply to Parent Post by J1980b View Post

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 ?
  Post Number #3  
Old 26th January 2012, 03:56 AM
J1980b

 
 
Total Posts: 14
Re: Class IIa Medical Device - Can I over label to change an address?

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
  Post Number #4  
Old 26th January 2012, 04:42 AM
pkost

 
 
Total Posts: 824
Re: Class IIa Medical Device - Can I over label to change an address?

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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