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  • 1.  Importer responsibilities for SaMD mobile app

    This message was posted by a user wishing to remain anonymous
    Posted 08-May-2023 15:15
    This message was posted by a user wishing to remain anonymous

    Hi All, 

    I'm reaching out in hopes someone can help me, and I would appreciate your advice: 

    - None - EU Manufacturer of SaMD mobile app. 
    - Currently, the App Store and google store do not take the responsibility of an Importer under MDR and insists on the act of the manufacturers' publishing the app (after the app store reviewed it) in the store. 
    - In this situation, the manufacturer does not have an importer with responsibilities and registration in EUDAMED 

    The question is if placing on the market of a SaMD mobile app is the manufacturers' act of publishing the app (after the app store reviewed it) in the store and, therefore, an importer is not required.

    Does anyone have experience with SaMD mobile app stores in such cases?

    Thanks in advance



  • 2.  RE: Importer responsibilities for SaMD mobile app

    Posted 09-May-2023 04:23

    Hello Anon,

    Read through the Blue Guide ... if the product is being shipped to and used direct by the consumer, then they/the Manufacturer become the Importer.  It is not that an Importer is not required necessarily, but the roles and responsibilities for this role may be shared/done by the Manufacturer and the consumer.



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

    Original Message


  • 3.  RE: Importer responsibilities for SaMD mobile app

    Posted 16-May-2023 10:44

    In the specific case of publishing a SaMD mobile app on platforms like the App Store and Google Play Store, it is important to understand that these platforms generally act as distributors rather than importers. They provide a platform for manufacturers to make their apps available to users, but they are not considered importers under the MDR. It's crucial to note that the responsibility for compliance with the MDR and the appointment of an authorized representative still lies with the manufacturer. Even if the app store reviews and approves the app before publishing it, the manufacturer retains the ultimate responsibility for ensuring conformity with the MDR requirements. Even though a importer is not required or not applicable, the responsibilities are taken by manufacturer, like system for monitoring the performance and safety of the SaMD in the EU market, reporting -serious incidents or field safety corrective actions to the relevant authorities, EUDAMED, etc



    ------------------------------
    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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