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  • 1.  Austria distributor registration

    This message was posted by a user wishing to remain anonymous
    Posted 03-May-2023 07:53
    This message was posted by a user wishing to remain anonymous

    Hi,

    I hope somebody who's knowledgeable about Austrian law can help me with this.
    I am trying to figure out if Austrian distributors are required to register in the Österreichischen Registers für Medizinprodukte as I find information stating that it is required, but also that its still on voluntary basis. Products are non custom-made and IVD Class A.

    Thank you in advance.

    Kind regards,



  • 2.  RE: Austria distributor registration

    Posted 04-May-2023 05:57

    Hello Anon,

    I am not sure about Austria specifically, but there is a statement in the EU MDR which Member States Economic Operator Distributors to register with the local Member State according to Article 30.  These are national provisions which are set up for registration of Distributors.  Because these varies country by country, it would be helpful to know which countries would have this requirement, but I am not aware of Austria currently.



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

    Original Message


  • 3.  RE: Austria distributor registration

    Posted 08-May-2023 04:30

    Hi Anon, 
    in Austria distributors shall notifiy products in the Medizinprodukteregister.

    Hope it was useful for you
    Regards




    ------------------------------
    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
    ------------------------------

    Original Message


  • 4.  RE: Austria distributor registration

    This message was posted by a user wishing to remain anonymous
    Posted 09-May-2023 08:17
    This message was posted by a user wishing to remain anonymous

    Dear Valentina,

    Thank you for your reply. Do you have the source for me?

    Thank you in advance.

    Kind regards,


    Original Message


  • 5.  RE: Austria distributor registration

    Posted 09-May-2023 08:26

    Here you should read about it

    Vertreiber/Händler

    In any case, that is the Austrian database link, so you can find anything you need.

    Regards



    ------------------------------
    Valentina Faziani
    Regulatory Affairs Specialist
    Thema s.r.l.
    Italy
    ------------------------------

    Original Message


  • 6.  RE: Austria distributor registration

    Posted 16-May-2023 10:57

    The registration of distributors based in Austria is voluntary but strongly recommended. Until now, distributors have been able to register in the Austrian Register for Medical Devices on a voluntary basis. This did not apply to distributors who placed medical devices on the market for the first time in the European Economic Area (EEA) and who, as importers, were subject to the registration obligation.
    Section 37 (1) of the new Medical Devices Act provides for a registration obligation for dealers based in Austria. Section 91 (2) MPG stipulates that distributors must comply with their registration obligation within one year of the federal law coming into force. Attention: distributors who import medical devices into the European Economic Area for the first time are considered importers and must register in the European Database for Medical Devices (EUDAMED). for more info 
    FAQ | Website Template (medizinprodukteregister.at)



    ------------------------------
    Raje Devanathan
    Amerisource Bergen
    TPIreg, Innomar Strategies
    Senior Manager - Regulatory Affairs, Medical Devices
    rdevanathan@tpireg.com
    3470 Superior Court
    Oakville ON L6L0C4
    Canada
    ------------------------------

    Original Message


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