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Requirements/guidance on what constitutes the Manufacturers "Address"


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  Post Number #1  
Old 17th July 2017, 06:32 AM
pkost

 
 
Total Posts: 745
Question Requirements/guidance on what constitutes the Manufacturers "Address"

Can someone point me in the direction of requirements/guidance on what constitutes the manufacturers "address"?

We are looking to move site and would prefer to keep using our current address on pack and documentation....What are the minimum requirements? What activities do we have to keep "on site" as it were?

I'm specifically interested in EU and US

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  Post Number #2  
Old 17th July 2017, 07:25 AM
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Jen Kirley

 
 
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Re: Requirements/guidance on what constitutes the Manufacturers "Address"

Why do you want to maintain your old address on pack and documentation?
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  Post Number #3  
Old 17th July 2017, 07:46 AM
pkost

 
 
Total Posts: 745
Re: Requirements/guidance on what constitutes the Manufacturers "Address"

There is a significant cost associated with changing address
  Post Number #4  
Old 17th July 2017, 10:44 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
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Re: Requirements/guidance on what constitutes the Manufacturers "Address"

Refer this interesting discussion: Address change on Medical Device labeling
Thanks to Ajit Basrur for your informative Post and/or Attachment!
  Post Number #5  
Old 18th July 2017, 04:46 AM
pkost

 
 
Total Posts: 745
Re: Requirements/guidance on what constitutes the Manufacturers "Address"

thanks ajit, this link appears to the relate to the short term maintenance of an address for product that is already or close to being on the market and where the original site is being closed down. I'm looking into it from an ongoing perspective where we retain minimal activity at the original site
  Post Number #6  
Old 19th July 2017, 09:42 AM
paulag

 
 
Total Posts: 58
Re: Requirements/guidance on what constitutes the Manufacturers "Address"

for the EU, MDD 93/42 Annex I requires the manufacturer's address on the Label, i.e., the "factory" pictogramm followed by the full address.

You should check what the new EU MDR requirements are, as the MDD is Fading out soon...
Thanks to paulag for your informative Post and/or Attachment!
  Post Number #7  
Old 19th July 2017, 10:27 AM
pkost

 
 
Total Posts: 745
Re: Requirements/guidance on what constitutes the Manufacturers "Address"

Thanks PaulAG,

the MDD (and similarly MDR) are a little vague...what if I have multiple sites? Is it head office? is it the site where the regulatory team are? is it where the technical documentation is maintained or where complaints are process? can it be any of the sites that we own?
  Post Number #8  
Old 20th July 2017, 01:19 AM
paulag

 
 
Total Posts: 58
Re: Requirements/guidance on what constitutes the Manufacturers "Address"

Quote:
In Reply to Parent Post by pkost View Post

Thanks PaulAG,

the MDD (and similarly MDR) are a little vague...what if I have multiple sites? Is it head office? is it the site where the regulatory team are? is it where the technical documentation is maintained or where complaints are process? can it be any of the sites that we own?
Hello pkost,

we also have multiple sites for different manufacturing or administrative steps, even in different EU countries. The address on the label is the one on the respective 93/42 certificate, and the Notified Body was happy with that so far. Why don't you contact them and see if they agree with your approach?
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