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Company name change and product labelling

Discussion in 'EU Medical Device Regulations' started by Jo Campbell, Oct 9, 2015.

  1. Jo Campbell

    Jo Campbell Member

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    Hi All,

    We have recently undergone the painful process of changing our company name, and as a result now have a warehouse full of stock labelled with the old name and logo. For Europe our product was registered under the old name, and our notified body have been informed of the change, so the countries we were already distributing to are aware and recognise our product labelled with the previous name. However, for European countries where we have not yet distributed, who require additional documentation to register, can we then go on to provide the old stock? My concern is that the registration will be in the new company name, but the product labelled differently. My gut feeling is that the product should be labelled with the company name that appears on the licence. Am I correct, and if so is there anything we can do (other than re-labelling of course) to rectify this?

    Your help on this matter will be very much appreciated.

    Jo
     
  2. Rich008

    Rich008 Member

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    I think it needs to be what you have on your licence, until the licence has been updated to your new name.

    I would check with your EU licence issuer.
     
  3. Jo Campbell

    Jo Campbell Member

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    Thank you Rich008.

    Our licence is in the new name, it's our product that isn't. I'm guessing that we will have to re-label all the stock before it can be despatched.
     

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