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  • 1.  MDR Economic Operators

    Posted 22-Mar-2019 11:03

    If we sell and deliver a medical device directly to a hospital in the EU, does my customer become the Importer and fall under the requirements of an Economic Operator?

     

    Thanks

     

    Al Van Houdt, RAC

    Sr. Mgr. Regulatory Affairs & Compliance

     

    Spacelabs Healthcare

    o 425-363-5970

    m 425-281-7683

    Fax 425-363-5762

    www.spacelabshealthcare.com

     

     



  • 2.  RE: MDR Economic Operators

    Posted 25-Mar-2019 02:29

    ​Hi

    If your customer imports products from outside of the EU, then your customer will become importer. If your customer receives products inside the EU and sell to hospital, your customer will be distributor. Both cases, your customer becomes an economic operator.
    As intention to create economic operator in EU MDR is to have traceability obligation in entire supply chain, both of importer and distributor are economic operators.
    If you look at the responsibility at the EU MDR, both of importer and distributor are quite similar while importer has a couple of more obligations such as EUDAMED registration and affixing labels. EUDAMED registration will cost annual fee.

    Hope it helps.
    JP



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    Jeongpyo Hong
    Sr. Professional, Regulatory Affairs
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    Original Message


  • 3.  RE: MDR Economic Operators

    Posted 25-Mar-2019 03:50
    This is a very good question. I guess it depends if delivering a device directly to a hospital is seen as placing the device on the market or putting it in to service. The difference is subtle and I am not sure of the correct interpretation here. If the delivery of a device from a third country (Non-EU) directly to a hospital ​is seen as placing on the market, then the full scope of article 13 will apply to the hospital, because the hospital would fulfil the definition of importer according to article 2(33). Because the hospital does not intend to further distribute the device in the EU market, some of these obligations would not make a lot of sense (labeling, SRN, etc.).  I would be inclined to think that because the device is not further distributed, the hospital is not seen as the importer, but this my personal interpretation and would welcome additional opinions.

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    Andrea Sparti
    Regulatory Affairs Manager
    Bienne
    Switzerland
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    Original Message


  • 4.  RE: MDR Economic Operators

    Posted 26-Mar-2019 03:08
    Edited by Tina O'Brien 26-Mar-2019 03:13
    Great information!  

    We're just now getting into OUS markets, so would like to clarify my thinking to distinguish between a direct customer who's an independent importer/distributor who simply purchases our products for resale on their own behalf and a 3PL, a service provider moving or selling our products on our behalf. 

    Obviously, the latter would be in scope of Supplier Mgmt (quality agreement, audits, SCARS, etc).  I envision with the former that we'd simply have an executed purchase contract that details the terms and pricing including conrent stating that each party will comply with applicable regulations - without going into the Supplier Mgmt bucket. 

    Either way, do I understand the MDR correctly that the economic operators are accountable to the CA (and NB for manufacturers) for MDR compliance?  Does this mean that the manufacturer does not need to ensure that their direct economic operator is carrying out their obligations?

    Thoughts?

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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    Original Message


  • 5.  RE: MDR Economic Operators

    This message was posted by a user wishing to remain anonymous
    Posted 02-Apr-2019 17:21
    This message was posted by a user wishing to remain anonymous

    According to the Blue Guide in Europe,

    "The making available of a product supposes an offer or an agreement (written or verbal) between two or more legal or natural persons for the transfer of ownership, possession or any other right concerning the product in question after the stage of manufacture has taken place. The transfer does not necessarily require the physical handover of the product."

    This opens up the door to allow you to have an intermediate entity be the importer even though you are shipping the product directly to the customer.  You will need to have proper contracts and Quality Agreements in place that delegate the importer's responsibilities.  Consider what responsibilities you can delegate back to the manufacturer (eg, applying importer label, storage and transport conditions).  If you set up a legal entity in the EU of your own company (one option), you may be able to delegate other responsibilities (eg, complaint reporting).  I recommend getting your legal department and finance departments involved as there may be tax implications in doing this and your legal department can help you figure out what MDR responsibilities you can delegate.
    Original Message


  • 6.  RE: MDR Economic Operators

    Posted 02-Apr-2019 17:42
    Thanks Anon! 

    What if we're simply selling product to an importer - they're paying us for X amount of product, we hand it over, then it's no longer under our control or possession.  We don't have any visibility as to the remainder of the supply chain who are the Importer's customers - not ours.  

    Of course we have a purchasing agreement in place detailing pricing and also stating that each entity will comply with applicable laws and regulations.  What I don't want to do is treat the Importer as a service supplier and create a quality agreement, conduct audits, etc., when in fact they are our customer and not providing a service to us.  

    Tina

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    Tina O'Brien RAC, MS
    Director of Regulatory Affairs
    Airport Oaks
    New Zealand
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    Original Message


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