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  • 1.  CE mark - Same product registered under 2 names

    Posted 26-Oct-2017 07:30

    Hi everyone,

    I would like to ask a question regarding the registration here in Europe. Is it possible that the same manufacturer Registers the same product family under 2 Brand Names? So the manufacturer will have the same product under NAME A and NAME B. 

    Thanks a lot in advance. Your help is really appreciated!



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    Carmen Herraez
    Carouge
    Switzerland
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  • 2.  RE: CE mark - Same product registered under 2 names

    Posted 26-Oct-2017 08:13

    ​I see nothing in the Directives that would prohibit it. For me, the single most important thing is that you clearly identify yourself as the "manufacturer" of the devices of NAME A and NAME B and that you cleary draw up EU Declarations of Conformity for devices with NAME A and NAME B. Furthermore, in your Technical Documentation you should keep it very clear that bench test data or clinical data apply to both devices of NAME A and NAME B. And pay attention to aspects of traceability, including any (future) UDI, labeling, statistics for any product non-conformities, complaints, service reports, etc.

    This is my honest opinion. In case of doubt you should consult your Notified Body.



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    Ary Saaman
    Director, Regulatory Affairs
    Debiotech S.A.
    Lausanne
    Switzerland
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    Original Message


  • 3.  RE: CE mark - Same product registered under 2 names

    Posted 27-Oct-2017 10:01
    ​Dear Carmen

    There is no problem with that. Depending on whether you have to involve a Notified Body for the conformity assessment and the class of the product, there are different things to keep in mind:

    - In case it's a class I medical device (no measuring function and not provided sterile), you simply complement your technical documentation with the information about the new device. From a quality management perspective the easiest is to document this through a change (or a letter to file). Make clear that all Information in the technical documentation is equally applicable to device B and add product-specific information (e.g. IFU, Labels, art-work etc.). Then add Product B on the declaration of conformity for product A or issue a new declaration of conformity.
    - In case of all other classes  do the same. In Addition I recommend informing the Notified Body about the fact that you want to place the same product with another brand name on the market (I'm also a freelance lead auditor for a Notified Body and this is what I would expect from my clients). If the brand name is not mentioned on the EC certificate (which is normally the case for lower risk class products), no new EC certificate needs to be issued.
    - In case the products are specifically mentioned on the EC certificate, a new one needs to be issued by the Notified Body.

    Hope this helps!

    Cheers, Beat

    ------------------------------
    Beat U. Steffen
    Founder, CEO
    confinis ag
    Duedingen
    Switzerland
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    Original Message


  • 4.  RE: CE mark - Same product registered under 2 names

    Posted 31-Oct-2017 17:27
    Dear Carmen,

    launching a second brand is possible, however in this case the IFU/price of the 2nd brand should be identical/not significantly different, otherwise the Consumer Protection Agencies may be involved if get complaints from customers.

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    Peter Mikó M.D
    ArtPharm Ltd.
    Gyermely
    Hungary
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    Original Message


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