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  • 1.  Marketing of third party devices in EU

    Posted 09-Jul-2019 07:26
    Hi,
     
    We have obtained marketing rights of a third party manufactured CE marked Class IIa device. What are our responsibilities as a marketing authorization holder?
     
    Thanks & Regards,
     
    Rashmi Pillay
    Regulatory Affairs Associate

    Ellex 
    3-4 Second Avenue
    Mawson Lakes SA, 5095
     
    T + 61 8 7074 8105
    E  rpillay@ellex.com
    W ellex.com
    .............................................................................
     
    One Powerful Vision.
    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 
     

     
     
     


  • 2.  RE: Marketing of third party devices in EU

    Posted 09-Jul-2019 09:00
    Are you thinking of general good marketing/distribution practices?
    Or the specific requirements for particular countries?

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 3.  RE: Marketing of third party devices in EU

    Posted 09-Jul-2019 18:25

    Hi Anne,

     

    Specific requirements of the particular countries.

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     




    Original Message


  • 4.  RE: Marketing of third party devices in EU

    Posted 09-Jul-2019 23:50
    So, assuming those countries are all in the EU, you're probably following the MDD for now, while planning to follow the MDR soon.
    Then, the rules that apply to your company will depend on the specific roles​ you're filling.
    Is the manufacturer located in the EU, or do they have an authorised representative there?
    Is the device already registered with one or more competent authorities?
    Are you importing the device into the EU?
    Are you distributing it there?
    Are you advertising it there?

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 5.  RE: Marketing of third party devices in EU

    Posted 09-Jul-2019 23:58

    Hi Anne,

     

    Responses to your questions –

     

    Is the manufacturer located in the EU, or do they have an authorised representative there? – the manufacturer is in the EU
    Is the device already registered with one or more competent authorities? –     Yes it is
    Are you importing the device into the EU?     Yes
    Are you distributing it there? Yes
    Are you advertising it there? Yes

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     




    Original Message


  • 6.  RE: Marketing of third party devices in EU

    Posted 11-Jul-2019 23:58
    Hi Rashmi

    If the manufacturer is located in the EU, then probably you don't have the importer role...
    Look at section 3 of the Blue Guide:
    http://ec.europa.eu/DocsRoom/documents/18027/
    It may help to clarify which roles you're filling, and then it explains the basic responsibilities pretty well.​

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 7.  RE: Marketing of third party devices in EU

    This message was posted by a user wishing to remain anonymous
    Posted 15-Jul-2019 09:03
    This message was posted by a user wishing to remain anonymous

    Hi Anne

    What if the manufacturer is located outside of EU and have an AR in EU?

    Thank you!
    Original Message


  • 8.  RE: Marketing of third party devices in EU

    Posted 15-Jul-2019 22:53
    If the manufacturer is outside the EU, and you want to distribute inside the EU, then an importer will be involved. If it's you doing the importing, then the importer responsibilities apply to you.​

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


  • 9.  RE: Marketing of third party devices in EU

    Posted 17-Jul-2019 01:43

    Anne,

     

    Back to the importer role. Thanks for the link to the Blue Guide. Although the manufacturer is in the EU , the device would be first shipped to us (in Australia) and then shipped from here to EU . So then don't we then need to have an authorised EU Rep? Then don't we  need to assume the importer role if we are responsible for the marketing of the device ?

     

    Thanks & Regards,

     

    Rashmi Pillay
    Regulatory Affairs Associate


    Ellex 

    3-4 Second Avenue

    Mawson Lakes SA, 5095

     

    T + 61 8 7074 8105
    E  rpillay@ellex.com

    W ellex.com

    .............................................................................
     
    One Powerful Vision.

    Confidentiality: This e-mail is from Ellex Medical Pty Ltd, ABN 35 008 276 060. The contents are confidential and intended only for the named recipient of this e-mail. If the reader of this e-mail is not the intended recipient you are hereby notified that any use, reproduction, disclosure or distribution of the information contained in the e-mail is prohibited. Viruses: Any loss/damage incurred by using this material is not the sender's responsibility. No warranty is made that this material is free from computer virus or other defect. Ellex Medical Pty Ltd entire liability will be limited to resupplying the material. If you have received this e-mail in error, please reply to us immediately and delete the document. 

     



     




    Original Message


  • 10.  RE: Marketing of third party devices in EU

    Posted 19-Jul-2019 09:42
    Hi Rashmi.  From the Blue Guide: "​The importer is a natural or legal person established in the Union who places a product from a third country on the EU market." Since you're not established in the Union, and the product is not manufactured outside the Union, it does not appear that the importer role could apply to you.

    And from the Blue Guide: "Whether the manufacturer is established in the EU or not, he may appoint an authorised representative in the Union to act on his behalf in carrying out certain tasks required in the applicable Union harmonisation legislation". Since the "authorised representative" (or "EC REP") role is defined in relation to the manufacturer, and you are not the manufacturer, the rule does not apply to you. (Which is not to say that you couldn't hire someone within the EU to represent some of your interests there, as defined by you.)

    ------------------------------
    Anne LeBlanc
    Manager, Regulatory Affairs
    United States
    ------------------------------

    Original Message


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