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  • 1.  CE mark Transfer

    Posted 22-Jul-2016 09:20
    Edited by Carmen Herraez 22-Jul-2016 09:26

    Hi Everyone,

    I would like to ask a question regarding the transfer of a CE mark from one manufacturer to another (with different notified bodies). 

    In our case, we would like to acquire the CE mark of a product, but we will also acquire all their intellectual property (patents, brand…), contracts with the suppliers (all production is outsourced), etc.  so we will have exactly the same product produced, there would be only a change in the QMS. So what are the steps to follow? Is there any guideline / document explaining the process?

    My second questions is: in the case that the original manufacturer of the product had non-conformities in their last audit (not related to the product manufacturing as they outsourced all the production), would we need to address these non-conformities as the 2nd manufacturer before transferring the product registration to us? The original company went bankrupt so they will not solve their issues with the NB.


    Thanks in advance,

    Regards,
    Carmen

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    Carmen Herraez

    Regulatory Affairs Manager

    Acrostak International Distribution Sàrl

    Switzerland



  • 2.  RE: CE mark Transfer

    Posted 22-Jul-2016 09:52

    I am confident this is possible.

    Although you will probably get useful comments from colleagues via the inquiry you have initiated, I urge you simply to contact your own Notified Body.  They will surely be experienced in this sort of product transfer, and since they are the ones who will ultimately have to approve the result, they will be the best ones to provide guidance.  (NBs are not allowed of course to consult as such, but since this simply amounts to specifying the process to be followed, this will be ok.)

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    William White
    Senior Consultant
    Quality System Strategies LLC
    Elkhart IN
    United States

    Original Message


  • 3.  RE: CE mark Transfer

    Posted 23-Jul-2016 10:30
    Carmen,

    In view of your description, it falls under the category of "voluntary change."

    Please refer to the NBOG's Best Practice Guide entitled "Change of Notified Body" to understand the process.

    Then you would need to communicate with your current NB.

    D



    Original Message


  • 4.  RE: CE mark Transfer

    Posted 29-Jul-2016 12:07

    I would like to add that "acquiring the CE mark of a product" sounds technically incorrect and a practice not allowed by the EU regulations. According to the EU regulation, a legal entity who fulfills some obligations, requisites and successfully follows a "conformity assessment procedure" is allowed to make a declaration of conformity to the relevant medical device directive and can apply the CE mark to the MD. Such conformity assessment procedure may involve notified bodies inspection and the assessment of the quality assurance system against specific requisites.

    In case the only change is the name of the legal entity - e.g. because of a change in property of the firm, while keeping unchanged the rest of the things including the staff, managers, organizations, place of manufactures, suppliers, Notified Body, etc., then the process should be administrative only. However, it seems you are planning to change the NB as well...

    Regards

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    Lorenzo Muratori
    Elekta
    West Sussex
    United Kingdom

    Original Message


  • 5.  RE: CE mark Transfer

    Posted 02-Aug-2016 10:39

    Carmen, 

    Yes - this is possible to do but there are a couple of options available to you. 

    Your new/current NB (whichever one you speak with) will not be able to give you advise as they are not allowed to consult. 
    It is also always helpful to ensure that you have an idea of what you want (knowing your regulatory area of play) will ensure that they are more able to support you as a partner NB. 

    The two options you have are:

    1. Option I: acquire bankrupt company including the currently CE marked device. This means that the legal entity name changes and the QMS carries on as is with no changes. Lets call this NB 1 and QMS 1. Your company can then swap NBs to NB 2 which will be an easy transfer; usually the two most time intensive part of this transfer is the changes in packaging (notified body number) and managing the length of validity of the CE mark that the product has with NB 1 (bear in mind that you also have to do same for the MD{QMS} certificate too. 
    2. Option II: introduce the product into your already existing QMS and transfer the CE mark from the existing company. This is the easiest of the two options and means you do not have to take on the NCs of the now bankrupt company nor its QMS. 

    My preference is two in this instance is option II as there is no exposure to the other business's QMS. 
    I hope this helps. 

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    Diana
    Royston
    United Kingdom

    Original Message