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  • 1.  UKCA marking - roles and responsibilities

    Posted 15-Jun-2023 04:42

    Dear community

    We have a question regarding the roles of Importer and Distributor in the UK.

    Reference: Guidance UKCA marking roles and responsibilities (https://www.gov.uk/guidance/ukca-marking-roles-and-responsibilities#distributors)

    Distributors

    A distributor is a person in the supply chain, other than the manufacturer or importer, who makes products available on the GB market. If a person is bringing in a product from outside of the UK and placing it on the market, they will be considered an importer under the legislation and therefore these persons cannot be distributors.

    Currently, it is foreseen that the importer and distributor will be same entity for our product to be registered in the UK.

    According to the above mentioned definition this will not be possible anymore, once the product will be UKCA marked.

       

    Our questions:     

    •          According to UKCA requirements is there a need to separate the entities (importer and distributor)?
    •          Is there an option to keep the importer and distributor as one entity?

    Thank you very much.

    KR

    Stefanie



    ------------------------------
    Stefanie Stark
    Manager Regulatory Affairs
    Burgdorf
    Switzerland
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  • 2.  RE: UKCA marking - roles and responsibilities

    Posted 16-Jun-2023 02:03

    Hi Stefanie,

    Ummm because UK MHRA is wrong or quite wrong in their approach?  Or they got the wording wrong?  In fact, it contradicts the wording previously for defining an Importer.  You are correct many companies would use one entity to be their Importer and Distributor especially in some countries because it would only be viewed as a "single market" to the organisation, like shipping and selling products in the UK.  It is guidance and the UK regulations are in flux right now.  I personally have already written a note to MHRA on this item because in reality this would not be realistic nor in some cases feasible.  The intent which I understand is to have an Importer as an independent entity confirming product coming into the UK is in compliance, thus not sharing this role with a Distributor, but again in reality and common practice it is not done or sometimes economically feasible.  



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    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 3.  RE: UKCA marking - roles and responsibilities

    Posted 16-Jun-2023 02:12

    Hi Richard

    Thanks for your feedback and additional explanations.

    Good to hear that you already took action, please keep us informed.

    Will discuss internally and may approach MHRA too.

    KR

    Stefanie



    ------------------------------
    Stefanie Stark
    Manager Regulatory Affairs
    Burgdorf
    Switzerland
    ------------------------------

    Original Message


  • 4.  RE: UKCA marking - roles and responsibilities

    Posted 16-Jun-2023 02:48

    The importer is defined as: 'An importer is anybody (individual or business) established in the UK who supplies a product from outside the UK for distribution, consumption or use on the GB market in the course of a commercial activity' 

    This means that an importer has the same role as the distributor, plus they place the device on the UK market. Therefore, it is fully aligned with the UK Regulations to have one single company taking care of importation and distribution. Just take care to call them the importer and not the distributor. 



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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    Original Message


  • 5.  RE: UKCA marking - roles and responsibilities

    This message was posted by a user wishing to remain anonymous
    Posted 16-Jun-2023 09:38
    This message was posted by a user wishing to remain anonymous

    "If a person is bringing in a product from outside of the UK and placing it on the market, they will be considered an importer", this is consistent with the definition of a UK importer, "An importer is an organization or entity that brings goods into the UK from outside of the UK and makes them available on the market in Great Britain for the first time."

    For a non-UK based manufacturer, a UKRP, however, can act as a UKRP and as a UK importer or a UK distributor. A separate UK entity can then act as the UK importer or the UK distributor (whichever role the UKRP is not). This, of course, is if the UKRP is willing to act as two roles (with a documented agreement).


    Original Message


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