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  • 1.  Economic operator under MDR/IVDR

    This message was posted by a user wishing to remain anonymous
    Posted 29-Mar-2023 06:54
    This message was posted by a user wishing to remain anonymous

    Hello experts,

    Can one entity be an EU Authorized Representative, Importer, and Distributor under MDR/IVDR?

    Thank you.



  • 2.  RE: Economic operator under MDR/IVDR

    Posted 29-Mar-2023 08:48

    Hello Anon,

    Under the EU MDR/IVDR:

    • An entity cannot share the role of Importer and Distributor for the same device.
    • An entity can share the role of EU Authorised Representative and Importer for the same device.
    • An entity can share the role of EU Authorised Representative and Distributor for the same device. I haven't seen this in practice, however.
    • An entity cannot share the role of Manufacturer and EUAR, Importer, and Distributor.

    Of course, an entity can fulfill all roles for different devices.



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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
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    Original Message


  • 3.  RE: Economic operator under MDR/IVDR

    Posted 30-Mar-2023 06:13

    Anon,

    Additional comment from what Peter has provided.  Ensure the EU Authorised Representative roles and responsibilities (if for the same device) are independent from the roles completed by Importer or Distributor.  We have seen companies challenged on when personnel and especially the Person Responsible for Regulatory Compliance (PRRC) for the EU AR are not independent from "quality" activities related to the Importer/Distributor.  In fact, even so far as having different reporting structure in the same company to maintain bias and independence for the EU AR roles and responsibilities.



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


  • 4.  RE: Economic operator under MDR/IVDR

    This message was posted by a user wishing to remain anonymous
    Posted 30-Mar-2023 07:35
    This message was posted by a user wishing to remain anonymous

    Dear Peter,

    Thank you for your quick feedback. It helps me a lot. If possible, could you please let me know source Article of the following your advice?

    > An entity cannot share the role of Importer and Distributor for the same device.

    Best regards,


    Original Message


  • 5.  RE: Economic operator under MDR/IVDR

    Posted 31-Mar-2023 10:42

    Dear Anon, you can find this in article 2. Definitions: 
    (34) 'distributor' means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service;



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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Arnhem
    Netherlands
    ------------------------------

    Original Message


  • 6.  RE: Economic operator under MDR/IVDR

    Posted 03-Apr-2023 09:55

    Hello Anon,

    in addition to what Peter correctly stated, you can find information on the interpretation of distributor/importer in MDCG 2021-27 (https://health.ec.europa.eu/system/files/2021-12/mdcg_2021-27_en.pdf) and on EU Authorised Representatives in MDCG 2022-16 (https://health.ec.europa.eu/system/files/2022-10/mdcg_202216_en.pdf).

    Best regards
    Christoph



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    Christoph Kiesselbach
    Reutlingen
    Germany
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    Original Message


  • 7.  RE: Economic operator under MDR/IVDR

    This message was posted by a user wishing to remain anonymous
    Posted 30-Mar-2023 07:35
    This message was posted by a user wishing to remain anonymous

    My apologies for sending multiple e-mails.

    I have read other related discussions, and now it is clear to me that an Importer can sell a medical device directly to end-users. In such a case, the Importer needs to meet the requirements of Article 13, but not the requirements of Article 14 as a Distributor.

    Thank you.

    Best regards,


    Original Message


  • 8.  RE: Economic operator under MDR/IVDR

    Posted 04-Apr-2023 07:13
    Edited by John Zachary 04-Apr-2023 07:13
    Yes, one entity can act as an EU Authorized Representative, Importer, and Distributor under MDR/IVDR. However, each role has specific responsibilities and obligations that must be fulfilled.
     
    1. Authorized Representative: A non-EU manufacturer must designate a sole Authorized Representative established within the EU (Article 11(1) MDR and IVDR). The Authorized Representative is responsible for assisting the manufacturer in fulfilling its obligations and ensuring compliance with the regulations (MDCG 2022-16, Paragraph 7).
     
    2. Importer: An entity meeting the definition of Article 2(33) MDR/Article 2(26) IVDR can act as an importer. Importers are responsible for verifying that the Authorized Representative has been designated by the manufacturer (MDCG 2022-16, Paragraph 8) and must register in EUDAMED (MDCG 2021-27, Page 9, Paragraph 1).
     
    3. Distributor: A distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, that makes a device available on the market (Article 2(34) MDR/Article 2(27) IVDR). Distributors do not have to register in EUDAMED but may be subject to national registration requirements (MDCG 2021-27, Page 9, Paragraph 2).
     
    Each entity must ensure compliance with all applicable regulations for each role it assumes.

    An entity typically refers to an organization with a single legal personality. However, a larger organization may consist of multiple legal entities, each with its own legal personality and responsibilities. In the context of the MDR, if a notified body is a legal entity that is part of a larger organization, the activities of that organization, its organizational structure and governance, and the relationship with the notified body must be clearly documented (MDR, ANNEX VII (1.1.2)). Each legal entity within the organization would be subject to the applicable requirements and responsibilities.



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    John Zachary
    Orca1 DI
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    Original Message


  • 9.  RE: Economic operator under MDR/IVDR

    Posted 05-Apr-2023 02:47

    Adding to Zach's post:
    4. System and Procedure Pack Producer (SPPP), see Article 22 MDR; if you put products together in order to achieve a specific medical objective AND this is done without changing the intended purpose of these products AND they are mutually compatible, your are considered an SPPP. This requires assigning of a specific Basic UDI-DI and often also adding a UDI-DI to the outer packaging (there are exceptions). A manufacturers, EU-based as well as non-EU, can become SPPP, so all should carefully consider if they are in that role. This role can also be combined with all other roles (AR, importer, and distributor). At the same time, there is room to play around with various options of combining products. Reach out if you want to get detailed guidance.



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    Ronald Boumans
    Schiedam
    Netherlands
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    Original Message


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