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  • 1.  EU importer responsibility delegation

    Posted 19-Jan-2024 03:26

    Dear all,

    we are company (MAN) outside the EU and therefore we need and have an Authorized Representative (AR) and an Importer (IMP). Additionally, we have a Logistics Hub (LH). AR and IMP are the same entity, a daughter of the MAN. LH is another daughter of the MAN. All entities share the same QM-System.

    The devices are delivered directly to the LH. LH and IMP are not in the same location. Thus, some IMP responsibilities are difficult to maintain (i.e. checking the actual goods). We do not want to switch complete IMP responsibilities to LH, for various reasons.

    We are thinking about setting up a contract between IMP and LH to delegate some responsibilities from IMP to LH. 

    Do you think this is feasible and are there some caveats or responsibilities we cannot delegate?

    Thank you for your insights!



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    Britta Cyron
    Senior Specialist Regulatory Affairs
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  • 2.  RE: EU importer responsibility delegation

    Posted 19-Jan-2024 08:08

    Hi Britta

    It seems logical. If IMP is actually doing the importing, they can engage LH to provide a warehouse and some associated services. If LH does everything, including the importing, then they would be the importer.



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    Anne LeBlanc
    United States
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  • 3.  RE: EU importer responsibility delegation

    Posted 19-Jan-2024 08:20

    Hi Britta,

    the responsibilities of the obligations of an Importer cannot be delegated. In general, one cannot delegate a responsibility.

    It is possible to outsource certain activities related to the obligations of the IMP to the LH and having IMP a suitable level of 'supplier control' over those outsourced activities to ensure IMP's responsibility. A contract should document the ins and outs of these arrangements, maybe even including QMS requirements. Key is that the IMP is in control of their obligations, whether performed by the IMP themselves or outsourced.



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    Peter Reijntjes
    Principal Consultant Regulatory & Quality Affairs | Head of Training
    Qserve Group (Netherlands)
    Heteren
    Netherlands
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  • 4.  RE: EU importer responsibility delegation

    Posted 19-Jan-2024 11:16

    Europe's requirements for medical device importers are fundamentally aimed at assuring an additional layer of impartial checks and balances on the manufacturer's conformity.  If the importer and manufacturer are part of the same legal entity (e.g., via a parent/daughter relationship), then that could raise conflict-of-interest questions.  For example, the importer's obligation to notify the competent authority (i.e., the government authorities) about serious risk or falsification of the manufacturer's device comes to mind, where such notification would seem to be hindered when the importer is governed by the manufacturer.  I would check with your Notified Body (if any) to confirm whether it will allow the importer to be part of the manufacturer and running under the same QMS.



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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright by ComplianceAcuity, Inc. All rights reserved.
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  • 5.  RE: EU importer responsibility delegation

    Posted 20-Jan-2024 02:28

    Dear Britta,

    The word 'importer' has at least three meanings with legal consequences:

    1. Logistics: someone physically carrying a product across a border;
    2. Tax: someone taking care of tax and duties;
    3. Regulatory: someone taking care of the regulatory responsibilities

    These roles can be taken by one, two, or three legal persons. 

    In the case of the Regulatory importer, they have to onboard the device. This means that they have to a check on the compliance of the device and if you read Article 13 carefully, this can be done via documentation. Next, they must release each shipment. Again, this can be done via documentation for devices that have been properly onboarded. There are some other administrative issues to consider. 

    Reach out if you want guidance on the details.



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    Ronald Boumans
    MDR Expert
    Super PRRC
    Netherlands
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  • 6.  RE: EU importer responsibility delegation

    Posted 21-Jan-2024 04:55

    As to the question whether you need a contract with the importer: no, this is not a legal requirement. Is it a good idea (possibly) and how to set it up? The MDR does not allow the IMP to outsource responsibility to the LM. But what you can do (and what a lot of medtech companies do in this case where AR and IMP are a subsidiary) is to agree that the LM mothership will do certain tasks for the IMP, such as help the IMP with device verification data. These contracts (I've written quite a few of those) help the LM and IMP to do rational load balancing of operational tasks and help the LM to fulfill its duty to source PMS data from the supply chain. If you need help with that, let me know.

    Is it a good idea to have AR and IMP be the same legal entity? That depends on the company's corporate risk management. Keep in mind that the AR and the IMP both have independent but separate roles and responsibilities in the Union traceability and compliance structure. That means if you combine these roles in a single enitity any knowledge about non compliance in one role is imputed to the other role as well. Also, at the moment the AR is product liable under the MDR, the IMP not (although the importer may be under general product liability). So there are certainly reasons to give this some good thought, also outside the regulatory department. Need help with that? Let me know.



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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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  • 7.  RE: EU importer responsibility delegation

    Posted 21-Jan-2024 13:03

    Dear Britta, 

    Congratulation on this solution.  

    Here is your question I believe needs the answer: "We are thinking about setting up a contract between IMP and LH to delegate some responsibilities from IMP to LH. 

    Do you think this is feasible and are there some caveats or responsibilities we cannot delegate?"

    Responsibility cannot be delegated, but certainly tasks may be delegated. I guess that would be the input to an agreement or the level of control excised between entities where an entity being responsible likes to have another entity perform certain tasks on its behalf.  

    You most likely had this right anyway and the question just needed to be rephrased exchanging the term responsibility with tasks and then the answer would be simply be: YES, and there are no tasks which cannot be delegated.  



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    Ludger Moeller
    President, MDSS GmbH
    l.moeller@mdssar.com
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  • 8.  RE: EU importer responsibility delegation

    Posted 22-Jan-2024 08:40

    Dear all,

    thank you for your insights. It has been very helpful! 
    To address some of your questions/remarks:

    MAN, AR, IMP, and LH being under one QMS is well established practice in our company for a couple of years now and was successfully audited by our Notified Body.

    When I was talking about delegation of responsibility, I was thinking in the lines of the RACI model (at least my understanding of it). The IMP being accountable and LH being responsible for the actual doing. I didn't think about a  slightly different meaning of 'responsible' acc. to MDR.

    What I learned:

    • We will be very careful while wording the contract/QA between IMP and LH.
    • We will also implement sufficient surveillance measures/'supplier control'.

    Thanks again everyone! If we will need further help in setting this up, I will reach out.

    Best,



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    Britta Cyron
    Senior Specialist Regulatory Affairs
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