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  • 1.  EU importer required?

    This message was posted by a user wishing to remain anonymous
    Posted 28-Oct-2021 16:13
    This message was posted by a user wishing to remain anonymous

    Hello RAPS community:

    Does a manufacturer located outside the EU need to appoint an importer for medical devices if the medical devices are sold directly to the end users?

    Thank you


  • 2.  RE: EU importer required?

    Posted 28-Oct-2021 19:41
    Ah yes, the million-dollar / million-person question...

    I've repeatedly questioned the Commission on that and for months they've not yet answered (while in the meantime answering other questions lodged later).  Evidently they seem to find the question pretty sticky as well.

    But to give credit where credit is due, the best answer I've seen (and is also how I approach it) is @Roger Gray's post here.  It was so well said by Roger that, well, 'nuff said.  And that says a lot from a capable long-wind-er like me...  :)

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    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 3.  RE: EU importer required?

    Posted 29-Oct-2021 03:21
    Ha, I'm not surprised that the Commission is doging this question because it's a very hairy one.

    As you point out Richard by reference to Roger's post this point has been solved in Regulation 1020/2019, the Market Surveillance Regulation, expect that …. the final clause of article 4 to which Roger refers states that this does not apply to medical devices. Article 4 (5) (the final clause) states that:
    "This Article only applies in relation to products that are subject to Regulations (EU) No 305/2011 (34),  (EU) 2016/425 (35) and (EU) 2016/426 (36) of the European Parliament and of the Council, and Directives 2000/14/EC (37), 2006/42/EC (38), 2009/48/EC (39), 2009/125/EC (40), 2011/65/EU (41), 2013/29/EU (42), 2013/53/EU (43), 2014/29/EU (44), 2014/30/EU (45), 2014/31/EU (46), 2014/32/EU (47), 2014/34/EU (48), 2014/35/EU (49), 2014/53/EU (50) and 2014/68/EU (51) of the European Parliament and of the Council."
    That's a lot of CE Regulations and Directives, but this list does not include the MDR and IVDR. So while the Market Surveilance Regulation does apply to aspects not specifically addressed in the MDR ((EU) 745/2017) and IVDR ((EU)746/2017), article 4 does not apply to MDR and IVDR regulated products.

    I personally have defended that it is possible to have permutations where the manufacturer is outside of the Union but there is no importer because there is no party in the supply chain that meets the definition of importer, such as the situation where you have an ex-Union manufacturer that produces devices for the Union in the Union (no devices from a third country in that case).  

    To answer the question of anon specifically however we need to start again by saying that you cannot appoint an importer (and that the geographic scope of the MDR is not the EU but the Union), but one rather has to check if the facts of the supply chain at issue meet the definition of importer in the MDR. Without any further facts this question cannot be answered in this case.

    This question is so difficult for the Commission because the Blue Guide 2016 makes the case that a fullfillment services provider can be a distributor in the meaning of CE marking legislation when he does more than just moving boxes (see under the heading "Distributors"), which would imply that an FSP could also be a more general economic operator (as defined in the MDR and IVDR) and therefore also an importer perhaps (because that is one of the economic operators) - except that the MSR states in article 4 (5) that this is not the case by not including the MDR and IVDR in the list of regulations and directives to which this applies. And that is the Commission's predicament here (I think).

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    Erik Vollebregt
    Partner
    Amsterdam
    Netherlands
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    Original Message


  • 4.  RE: EU importer required?

    Posted 29-Oct-2021 13:15
    Edited by Kevin Randall 29-Oct-2021 13:27

    Well, I guess there wasn't enough said... :)

    My current understanding is that the Commission's guidance on Regulation 1020/2019 Article 4 reveals the Commission's general principles for deciding if an importer is involved or not regarding direct sales.  I explain further below.

    First, let me mention that in my limited work thus far with Edgar Kasteel / MedEnvoy including his direct scrutiny/observation of my direction given to our mutual clients who are importers, he's not objected to my interpretation of Europe's importer requirements.  Yet ultimately for the context of this thread, it should be emphasized that MedEnvoy's importer business/profit model is based on importer set up and servicing.  Accordingly, that organization would seem to have a conflict of interest with respect to advising on supply chain models where there is not an importer.

    Getting back to Regulation 1020/2019 (hereinafter the "Market Surveillance Regulation"):  My current understanding (based on my interpretation of the Market Surveillance Regulation and its Commission guidance while I await more guidance from the Commission) is to remember first that the Market Surveillance Regulation 1020/2019 and its supplemental market surveillance provisions most definitely apply to EU MDR and IVDR medical devices.  This is pursuant to their inclusion in the Market Surveillance Regulation's Article 2 and Annex I.

    Yet as Erik reminds us, the purpose and scope of the Market Surveillance Regulation's Article 4 indeed excludes medical devices.  But I would say that's not the end of the story.  Specifically, Article 4, as I understand it, is essentially a gap-filler to shore up legislative gaps regarding economic operator accountability of certain product types whose current legislative acts leave something to be desired regarding economic operator accountability.  Article 4 essentially brings those lagging legislations up to the latest Commission state-of-the-art and interpretation (such as that embodied within more modern legislations like medical device Regulations 2017/745 and 2017/746) regarding the distinction of various economic operator roles and accountability.

    That said, this unfortunately doesn't mean that such state-of-the-art Regulations have themselves yet clearly articulated economic operator roles and accountability for direct-to-end-user sales.  And that is the rub whereby still further guidance is needed from the Commission.

    In the meantime, though Article 4's intrinsic purpose is to shore-up legislative weaknesses for certain product types, and therefore is not itself directly applicable to medical device Regulations 2017/745 and 2017/746 because those Regulations are already sufficient with respect to Article 4's unique aforesaid intent, the Commission's guidance on Article 4 nonetheless seems to reveal the Commission's general principles for deciding if an importer is required at all for direct-to-end-user sales.  That leads us back to the aforesaid explanation given by Roger Gray based on the Commission's aforesaid guidance, which concludes that there is no importer for direct-to-end-user sales, nor is there required to be so long as another economic operator (e.g., an authorized representative) performs the kind of premarket conformity assessments embodied within EU MDR Article 13 along with Europe's driving precedents from its longstanding common framework for the marketing of products.

    This approach is similar to how at least one other international medical device regulatory agency (the U.S. FDA) handles this scenario.  Specifically, for direct-to-end-user sales from outside the U.S., the FDA considers the end-user to be the importer.  Yet because of the end-user status, FDA doesn't require such importers to comply with FDA's regulatory requirements for importers.  That has come from FDA stepping out and stating that this is their interpretive position and enforcement discretion because, like with the Commission, the FDA's statutes and regulations don't clearly address importer obligations regarding direct sales.  Hopefully, the Commission will soon be willing to take a position on the matter.  It's looking to me like the Commission will ultimately echo the basic principle its already shown within its guidance for Market Surveillance Regulation Article 4.

    At this time, I have clients who've gone both routes, meaning either:

    1. Clients who have decided that the end user is the importer, yet where such an importer won't be required to fulfill the EU MDR's Article 13 obligations, or else they've decided there is no importer at all in such direct sales models; and
    2. Clients who have decided that there always must be a regulated importer meeting Article 13's obligations for direct sales from a third country, and who have thus designated a Union agent to essentially act, either in a physical or virtual capacity, as the Article 13 importer.


    If you're super concerned about the liabilities and compliance risk of failing to have an importer in case approach number  (a.) turns out to be the Commission's final stance, then by all means configure your situation to be like number (a.).  At least then the only risk at that point is the potential wasted costs (which could be sizeable) if it turns out an importer isn't legislatively required for direct sales from a third country.  But remember, we already have general Commission precedent showing that the Commission for a wide variety of risky products has already acknowledged that there won't be an importer for direct sales from a third country.  So there seems to be a very good chance the Commission will clarify that this principle is also applicable to medical devices. 



    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


  • 5.  RE: EU importer required?

    Posted 29-Oct-2021 03:57
    Hi,

    I would suggest you speak with Edgar Kasteel from MedEnvoy https://www.medenvoyglobal.com/ 
    These are the MDR/IVDR import compliance experts. Please do tell them I sent you.

    Best regards,

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    Richard Houlihan
    CEO Eudamed.com
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    Original Message


  • 6.  RE: EU importer required?

    Posted 29-Oct-2021 10:40
    Edited by Ed Panek 29-Oct-2021 10:43
    I suspect based upon the logic behind drafting the MDR to replace the MDD to be that the very first article in Chapter II is how devices are to be placed on the market and the first item is:

    "1. A device may be placed on the market or put into service only if it complies with this Regulation when duly
    supplied and properly installed, maintained and used in accordance with its intended purpose"

    In contrast to MDD the effort with MDR appears to be more accountability by parties within the EU and subject to direct EU oversight to take ownership in the revenue stream from these products and less finger-pointing. Because the requirements of an importer are so high and technical, I suspect there will be a requirement for an importer or a party that can be leveraged within the EU to penalties.

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    Edward Panek
    VP, QA/RA
    Med Device
    USN Veteran
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 7.  RE: EU importer required?

    Posted 29-Oct-2021 14:41
    Because EU MDR Article 5 (i.e., the first article in Chapter II) is only a clerically-revised narrative (except of course for generally calling for EU MDR conformity rather than MDD) that is essentially (yet not clerically) identical to MDD Article 2, and because the EU MDR's obligations for importers are specifically intended to be aligned with Europe's longstanding (i.e., like at least 12 years) common framework for product importers, I'm hoping that the Commission in fact doesn't really view the EU MDR importer requirements as something new and unprecedented.  That may be why they've not set the highest priority on answering requests for further guidance; indeed, my experience has been that if the Commission feels it's already sufficient addressed a topic, then it's not so readily willing to give additional answers/guidance to the same topic on a piecemeal basis thereafter.  So I do believe that when we communicate with the Commission about this topic, we should be careful about spinning EU MDR Article 13 as something new, as it was in fact imported (no pun intended) almost identically from the longstanding common framework whose intent was to coherently and uniformly shape the corresponding aspects of new legislations like the EU MDR.

    But without question, the general importer obligations that, for the MDD were "reference text" from the common framework prior to the EU MDR, have now been officially and legislatively mandated into the medical device sectoral legislation of the EU MDR.

    ------------------------------
    Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
    Principal Consultant
    Ridgway, CO
    United States
    © Copyright 2021 by ComplianceAcuity, Inc. All rights reserved.
    ------------------------------

    Original Message


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