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  • 1.  EU MDR Importers and Distributors

    Posted 31-Mar-2021 20:39
    Hi,

    I have a few questions regarding EU MDR. 

    (1)    If the CE marked product is not marketed commercially in EU, do we still need to designate an importer? I think the answer is "NO" as the organization is not distribute their product commercially

    (2)    Similarly, is a designated distributor required if the products are not commercially distributed?, Same here 

    (3)    Is conducting a clinical trial in Europe considered commercial use or "place in service"? I think it is considered a place of service.

    Any feedback or insight would be greatly appreciated.




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    Bhupinder Singh
    QA/RA Manager (RAC)
    San Jose CA
    United States
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  • 2.  RE: EU MDR Importers and Distributors

    Posted 01-Apr-2021 02:27
    Edited by Robert van Boxtel 01-Apr-2021 02:27
    Hi Bhupinder,
    Entities that are making a product for the first time available in the market (=placing on the market) are under the MDR/IVDR importers. Making available means supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge. The distributor (or distributors) is the entity 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.
    Terms like designated distributor are not in the MDR, but are commonly used in logistic supply chains. Any entity that performs the activities above, designated by you or not, is considered either an importer or distributor.
    It would be beneficial for these entities (both which are economic operators, let's call the economic partners), to be in contact with you as manufacturer, so they can better/more easier fulfill their regulatory obligations (article 13/14).
    Devices needed for the conduct of  clinical trail, pre-market - to obtain CE mark or extension of intended purpose, are investigational devices. The terminology above is not relevant for those products and entities.
    Devices needed for the conduct of  clinical trail, post-market, are to be CE marked and used within intended purpose. Then the terminology above applies again.

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    Robert van Boxtel
    Principal Consultant Medical Device Project B.V.
    Alphen a/d Rijn
    Netherlands
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    Original Message


  • 3.  RE: EU MDR Importers and Distributors

    Posted 01-Apr-2021 04:01
    Hello Bhupinder,
    Robert provides really good information about the designation and terminology which I just wanted to add a couple more points.  If you have a product which is CE Marked, Class I self-declare, then you are probably fine though if this CE Marked product is reviewed by a Notified Body, they may start questioning why the product is not on the market ... therefore, why you are maintaining a CE Mark.  Some companies get a CE Mark in order to leverage for regulatory licensure in other countries, and never end up selling in Europe.  In fact, a Notified Body might want to see an identified Importer.  A distributor may not be so important because you could sell through local country offices or even directly to end user.

    A clinical trial device falls under different requirements for the EU MDR - there are whole Articles and Annexes on this.  A clinical trial/clinical investigation device is not CE Marked, so does not really fall under the premise of "placing on the market."  Again, there are different requirements for devices used in clinical trials.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 4.  RE: EU MDR Importers and Distributors

    This message was posted by a user wishing to remain anonymous
    Posted 02-Apr-2021 15:36
    This message was posted by a user wishing to remain anonymous

    Hi Richard,
    A side question to your response: you mentioned that "A distributor may not be so important because you could sell through local country offices or even directly to end user." - if we have an Importer in the EU but we want to sell directly to end user through our website, and our own offices are outside the EU - would that be a problem?
    Is having an importer legally "place the device on the market" enough, even though we're the ones actually selling it directly from outside the EU?

    Thank you!
    Original Message


  • 5.  RE: EU MDR Importers and Distributors

    Posted 01-Apr-2021 08:25
    Hi Bhupinder, 

    I do understand correctly that you plan to perform a clinical trial in Europe with a device? If so, this is not regarded as putting into service [by the way, the MDR uses the wording 'placing on the market' and 'putting into service', not 'place in service']. Nor would you need to designate an importer or distributor for this.

    Hope this helps,

    Marc


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    Marc Klinkhamer
    Netherlands
    marc.klinkhamer@gmail.com
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    Original Message


  • 6.  RE: EU MDR Importers and Distributors

    Posted 03-Apr-2021 04:55
    Hello Anon,

    To further answer questions about Importer role under the EU MDR unfortunately is probably not too answerable yet.  The simple answer is yes, having an identified Importer constitutes "placing on the market".  However, this has been an on-going discussion in the industry, as well some posts here in this forum about when selling directly to end user in Europe.  The question becomes, who is the Importer in this case?  If for example selling a Class I OTC type of medical device over the internet, then I could theoretically have hundreds if not thousands of Importers, because each end user would be "placing on the market" as they take possession of the product.  There might be a way the Manufacturer could become the Importer but again there have been a number of threads discussion this topic how an Importer needs to be a separate entity than the Manufacturer.  Country offices, distributors, and importer(s) to me is not really a question because they can take on these Economic Operator roles, but I myself am not clear how this would occur with sales directly to end users.  This definitely gets into the very details of Articles from the Regulation and most likely more related to legal aspects as well.

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    Richard Vincins RAC
    Vice President Global Regulatory Affairs
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    Original Message


  • 7.  RE: EU MDR Importers and Distributors

    Posted 03-Apr-2021 06:42
    If a non-EU manufacturer sells a medical device directly to an EU end user there is no importer or distributor. The manufacturer is placing the device on the EU market.

    The 2016 Blue Guide covers this question.

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    Roger Gray
    VP Quality and Regulatory
    Donawa Lifescience Ltd
    UK Responsible Person services
    Christchurch, UK
    +44 1425 489208
    rgray@donawa.com
    www.donawa.com
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    Original Message


  • 8.  RE: EU MDR Importers and Distributors

    Posted 03-Apr-2021 21:24
    Note that some countries (e.g. Spain) requires an importer license issued by the Spanish Health Authorities (AEMPS) to dispatch the device at Spanish customs 
    Not for devices to be used in a clinical trial 

    Best regards
    Xavier Canals Riera
    Director - Euroingeniero, Ing. Telecom 
    Tecno-med Ingenieros, SL - Consultores Productos Sanitarios / Medical Device Consultants
    Parque Tecnológico BCNord, C/ Marie Curie num.8,  E08042 - Barcelona
    Tel: +34932917739 +34932917740 +34935353944 Fax: +34932998532
    Spaces Retiro, C/ Alfonso XII num.62  E28014 - Madrid Tel: +34910767142


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    Xavier Canals-Riera
    Director Tecno-med
    Barcelona Spain
    xcanals@tecno-med.es
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    Original Message


  • 9.  RE: EU MDR Importers and Distributors

    This message was posted by a user wishing to remain anonymous
    Posted 05-Apr-2021 08:16
    This message was posted by a user wishing to remain anonymous

    Thank you Richard and Roger!
    Original Message


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