Original Message:
Sent: 10-Jan-2024 18:04
From: Kevin Randall
Subject: EU MDR - Importer and Distributor
Hi Ludger. Thanks for your additional insights. It just dawned on me that the nuances of manufacturer controls over importers and distributors is probably too far off topic from the original questions of this thread. I'll start a new discussion for further exploration of that. See you there.
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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.
Original Message:
Sent: 10-Jan-2024 09:03
From: Ludger Moeller
Subject: EU MDR - Importer and Distributor
Dear Kevin,
Thank you for responding so quickly, and I appreciate the exchange as well. This could be a rather significant response if I want to address all the posts referenced. I will try to respond differently, and I hope that it does address the concerns and hopefully does provide further clarification. We certainly may discuss further.
For faster writing, I use I/D instead of Importer or Distributor.
In posts, the reference to Article 25, Article 10.9 (d), GHTF and ISO standard were made.
Article 25 indeed obligates, by law, the I/D to cooperate. However, there is no agreement needed and no oversight required by the manufacturer. We, as EC REP, dealt with an uncooperative distributor who refused to forward a FSN. Very much concerned we called to the authority what the manufacturer should do. At that time I was as well under the impression that EVERYTHING is the responsibility of the manuf. The authority responded: "NOTHING." A few minutes later, the Distributor contacted us to inquire what he is supposed to do. It would be good for the I/D to have an agreement in place that he gets compensated for his efforts. There is no mention in the MDR that the manufacturer must scrutinize what is already legally required via agreement.
In general, the MDR calls specifically calls out when an agreement is required. Logically there is not a agreement required if not called out. If an agreement is desired, then it needs to be carefully drafted regarding tasks and responsibilities. Tasks can be delegated - responsibilities not.
The biggest argument is that the I/D is a supplier. Most certainly if the I/D is determined to be a supplier, then the argument can be made that Article 10.9 (d) applies. However, it does not state anywhere in the regulation that I/Ds are suppliers. Also, as pointed out, that cannot be determined by the economic operator obligation for traceability under Article 25. It simply does not state that.
The main and mostly reference argument is the standard definition of ISO and the GHTF. I guess GHTF is mentioned since it seems to add some weight to the argument, but it simply refers to the ISO. The ISO definition lists "distributor," under supplier as example in order to think out of the box what what a supplier could be. It this now dead-on to determine that this term used in the standard way before the MDR must be applied to the legal entities as described in Article 13 and 14? I firmly do not think so. Let me explain why.
The ISO distributor may be anything and everything that is under the responsibility of the manufacturer. I could think of many examples.
a. FedEx is a distribution company and distributes products on behalf of the manufacturer to a I/D. Is FedEx equipped to ship products? Certainly, the shipper was selected by the manufacturer and this case it must be under the control of the manufacturer. I did audit those aspects as NB. One specific manufacturer was very impressive with having performed rigorous shipment tests and selected the right company to deliver their delicate products to the doorstep of the customer.
b. the product is being picked up by the Distributor. They use FedEx. The control for the manufacturer stops at his Dock. Article 13 or 14 kicks in and the responsibility of the transportation is with the I/D.
c. third Party logistic companies may distribute the product on behalf of the manufacturer or the I/D. Whatever is agreed upon in terms of the handover. At the dock of the manufacturer or at the dock of the I/D. This third party distributor would fall under the ISO and would be a supplier. The responsibility sticks accordingly.
Now a couple of other thoughts.
In general, we all struggle with the implementation of the regulations.
1. Notified Bodies are not regulators. They do their best. They are very often on the stricter side since they have been heavily scrutinized by the regulators to get the notification. I picture them having a belt and suspenders to keep their pants up. So, no leverage for a long time. They do not have an easy job.
2. Regulators try their best and have been put on the spot due to the scandals which were the initial cause for the MDR. They had the microphones in their face and had to answer the question why thousands of women needed to go under the knife to have their breast implants removed or why metal to metal hip replacements were implanted. You should have seen the first revision of the MDR before the scandals. Stakeholders today are still mad that they did not agree to it immediately. Then the scandals surfaced, and the MDR was changed.
3. Consultants struggle since they are measured by the success to meet the expectations of their clients to get the certificate. You better be on the conservative side.
All of this causes an overinterpretation of the MDR. At this point nobody is to blame for it. However, we should all help each other to get the requirements down.
In fact, the MDR is stricter and requires more documentation and reports. This was needed for the higher risk class III products. But is out of proportion for the me-too low-risk class products. However, in general the MDR is good interpretation of the MDD.
So, an example for the overinterpretation (OI) in our case.
1. The manufacturer must have a contract with the I/D. I saw it seriously presented by NBs and heavily communicated for a long time. → OI. It is clearly stated in the MDR where a contract is required. E.g., with the EC REP but it is not required with the I/D.
2. The manufacturer must appoint the I/D. → OI! The EC REP must be appointed.
3. NB can Audit the I/D. → OI! I got that out of the system during a high-level discussion with an important influential NB. Shortly thereafter, it was not stated anymore. It may not have been because of me. However, I am thankful that this is gone.
I was glad to see on LinkedIn recently the right responses pouring in when such a question was posed. Changes happen.
Overall, it is still an unhealthy environment and must change to keep products on the market. The first steps are being made and if we all work in the right direction to do only what is required and not more, a lot more patients can pay for the devices they need.
I like the exchange. It sharpens our views and hopefully we get better at this. Thank you again. Most certainly all the above may be challenged and I am open for further discussion.
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
Original Message:
Sent: 09-Jan-2024 13:59
From: Kevin Randall
Subject: EU MDR - Importer and Distributor
Hello Ludger, thank you for your additional questions and for your contributions to this Forum which are always appreciated.
I previously shared my experience and understanding, which are currently unchanged, of the EU MDR legislative basis for why European Notified Bodies staunchly continue to seek appropriate manufacturer control of Article 13 importers and Article 14 distributors. Those Forum posts (same thread) are here, and here, and here. They explain various Union MDR legislative parameters other than the Article 10(9) third paragraph indent (j) communication clause. In fact, I actually wouldn't consider that communication clause to offer any legislative basis for a manufacturer's supplier control over importers and distributors. Instead, I lodge the various other Union MDR legislative parts cited in my prior posts.
And to those prior explanations, I'd also add that the supplier controls of the harmonized standard EN ISO 13485:2016 as amended are a generally acknowledged state-of-the-art that influence how the Notified Bodies enforce regarding the Union MDR supplier controls required by Article 10(9) third paragraph indent (d). As we all know, consideration of the generally acknowledged state-of-the-art is a paramount feature of the Union MDR legislation and has been a longstanding requirement for decades under the outgoing MDD.
Other than these explanations giving multiple Union MDR legislative bases driving the Notified Bodies' demands for manufacturer supplier controls over its known importers and distributors, I really can't offer much further background or insights.
And regarding MDCG 2021-27 to which I believe you referred, my understanding is that that guidance isn't intended to address manufacturer obligations. Instead, its fundamental purpose is to clarify the importer and distributor obligations of Articles 13 and 14. Accordingly, I don't generally turn to MDCG 2021-27 when trying to understand a manufacturer's related responsibilities such as those in Article 10(9). My thinking is that even though Articles 13 and 14 describe various obligations solely applicable to importers and distributors, it doesn't mean that the Union MDR doesn't elsewhere contain manufacturer obligations related to those importers and distributors.
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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.
Original Message:
Sent: 08-Jan-2024 20:10
From: Ludger Moeller
Subject: EU MDR - Importer and Distributor
Hello Kevin,
Where does it say in the regulation that the manufacture must have oversight of the Article 13 Importer or Article 14 Distributor?
The MDR states under Artilcle 10:.
"The quality management system shall address at least the following aspects:
...
(j) handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
This is the only indication in the MDR concerning the obligation of the manufacturer regarding a distributor or an importer. They would fall under other economic operators. Handling communication does not mean oversight.
Certainly, I would like to be careful with my comments. I certainly do not want a manufacturer to receive a deviation regarding their quality system. However, if deviations are cited where they do not belong, it's important to address the issue.
I am still very much concerned if a manufacturer tries to apply oversight on the other economic operator. For example if I would import products I firmly would not allow my supplier (the manufacturer) to influence the inspection of the product I buy from him. If I would agree to of that I guess it would feel very odd. Trust is good but I would still apply my own checks on the products in accordance to my level of confidence concerning the supplier. And I would not have the supplier interfere with my obligation of Article 13 since I am responsible for it. Please refer to the MDCG Q and A.
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
Original Message:
Sent: 08-Jan-2024 14:12
From: Kevin Randall
Subject: EU MDR - Importer and Distributor
Hello Ching Yi Liu,
See my preceding post above from 08-Nov-2023 13:09 which explains the basis and interpretive intent for the MDCG 2021-27 statement that the same a natural or legal person cannot fulfil the role of importer and distributor "for an individual device". Specifically, "for an individual device" must be interpreted within, and is governed by, the EU MDR's "placing on the market" and "making available on the market" concepts which have been extensively discussed previously here in the Forum, along with the fundamental definitions for "importer" vs. "distributor". A key takeaway from these is that "placing on the market" is a unit / shipment-based supply chain concept, not a model or type-based concept. Based on these, importers intrinsically engage in colloquial distribution (in the form of "placing on the market") of the subject device (unit/shipment), but are not considered the Article 2(34) / Article 14 distributor.
Beware of notions that the manufacturer should, or is even allowed to, forego oversight of Article 13 importers and Article 14 distributors. For example, as has been covered before such as here and here in the Forum, regulators categorize the importers and distributors as important suppliers to the manufacturer. Moreover, from a basic business standpoint, an importer's or distributor's failure to meet its respective legislative obligations can adversely impact the manufacturer's supply chain and revenues. Ultimately, if a manufacturer decides to exclude its known importers and distributors from the manufacturer's oversight controls, then the manufacturer will likely be cited with a nonconformity(s) from regulators and could also experience a negative bottom line.
Also beware of assertions that the Union MDR requirements are only mandatory for importers if the importer sells the device to another entity. Specifically, "placing on the market" may be deemed to have occurred without sale (such as when there is a non-payment transfer of ownership, possession, or any other property right) between supply chain participants.
------------------------------
Kevin Randall, ASQ CQA, RAC (Europe, U.S., Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright by ComplianceAcuity, Inc. All rights reserved.
Original Message:
Sent: 08-Jan-2024 06:50
From: Ludger Moeller
Subject: EU MDR - Importer and Distributor
Dear Ching Yi Liu and Erik,
I am not sure how this now works in terms of RegEx. Whether this response goes back to the world or just to you two.
I hope it goes back to everyone since the question brought forward has been brought forwarded by others.
The answer from Erik is correct. I would like to add and hopefully not to the confusion. In order to provide the answer I copied the question.
Copied: "According to MDR, Decision 768/2008/EC and as No. 17 of MDCG 2021-27 Rev.1, "the same a natural or legal person cannot fulfil the role of importer and distributor for an individual device".
However, what if the importer (Company A) imported the device from the third country manufacturer and distribute the device by themself to the end user?"
The quick answer is: NO PROBLEM!
The wording "cannot fulfill the role" does not prohibit the making available of a product to the end user as Erik pointed out.
The Decision and the Guidance could use different wording. Instead of "cannot fulfill" it could also read "do not fulfill the role of importer and distributor for an individual device". The reason is that the role is determined by the mere of the doing so. What one is doing can not be done by the other one. In general going back to the definition. The Importer is making the product available for the FIRST TIME which is the significant aspect. That cannot be repeated by anyone for the one individual product. And this is furthermore reflected in the definition of the Distributor.
Copied: "In this case, can there only be an importer (Company A) but no distributor for this device?"
The quick answer is: YES!
There can be only an Importer who provides the product to end user like patient or health care facilities and he certainly may sell the product to a distributor.
Copied: "In other words, is the role of distributor necessary if the device have importer?"
The quick answer is: NO!
Please refer to my previous post for further clarification.
One other comment. It seems that manufacturer overstepping their area of concerns significantly. The Importer and Distributor are independent legal entities and they are not the responsibility of the Manufacturer. The obligation in the MDR are outlined for those entities who DO these things. There is no need for a manufacturer to step in to control the obligation of the Importer or of the Distributor. After seeing the inspection coming down on Importers and Distributors I would even warn Manufacturers to step in to try to control the Importer or the Distributor. Someone may ask why not? Because the role of the Importer and Distributor is also to scrutinize the products they sell. How does it is look like if manufacturer intervenes in any form or shape with this scrutiny. I would be very careful! What about if the checks required by the Importer are being determined and under the control of the manufacturer. How does that feel to you?
On the other hand the regulation is actually nice for the Importer and Distributor. It limits the responsibility and provides clear requirements on how to fulfill this limited responsibility to scrutinize the products.
Please let me know whether the above is helpful.
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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
Original Message:
Sent: 08-Jan-2024 02:30
From: Erik Vollebregt
Subject: EU MDR - Importer and Distributor
HI Ching Yi Liu,
In your example the importer would just be the importer. For MDR purposes both importer and the distributor can 'distribute' or in the words of the MDR 'make available'. Tthe difference is that the importer does the first making available of a device on the Union market and the dsitributor(s) every subsequent making available of that device. The confusion stems from the fact that people often link the collequial use of the words distribute and import to the regulatory roles of distributor and importer. An importer (regulatory role) can however distribute devices in the colloquial use of the word.
So in your example a distributor would not be necessary because the importer makes devices available directly to the end user.
Best regards,
Erik
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Erik Vollebregt
Partner
Amsterdam
Netherlands
Original Message:
Sent: 07-Jan-2024 22:56
From: Ching Yi Liu
Subject: EU MDR - Importer and Distributor
Thanks for the information above.
I would like to ask a further question regarding this topic--
According to MDR, Decision 768/2008/EC and as No. 17 of MDCG 2021-27 Rev.1, "the same a natural or legal person cannot fulfil the role of importer and distributor for an individual device".
However, what if the importer (Company A) imported the device from the third country manufacturer and distribute the device by themself to the end user?
In this case, can there only be an importer (Company A) but no distributor for this device?
In other words, is the role of distributor necessary if the device have importer? Thank you very much!
------------------------------
Ching Yi Liu
RA
RAPS Taiwan Chapter - ENTERPRISE
New Taipei City
Taiwan
Original Message:
Sent: 09-Nov-2023 11:56
From: Ludger Moeller
Subject: EU MDR - Importer and Distributor
Dear All,
These are great answers.
I believe the concern is somewhat different and the answers may still leave some doubts because as stated distributor cannot be the importer. I would like to try to rephrase the question, and this may give a different perspective.<o:p></o:p>
- Can someone from outside the EU sell the product to the EU? Yes. He sells the product to someone in the EU!
- The one in the EU who receives the product. Can he sell the product to somebody else? Yes. He can sell the product as he wishes to anybody!
- This anybody can he sell the product to somebody else? Yes.
- And so on.
The important conclusion here is that the MDR does not restrict the trade within the supply chain. However, whoever is involved at different stages specific responsibilities apply. This may clarify that an importer can basically do the same as the distributor regarding trade aspects. So, if number 2 is doing the same as number 3 he receives a different label. And that is for a reason.<o:p></o:p>
Let's see what the reasons are:
- The one from outside the EU may be the manufacture. He indeed markets the product (see definition MDR manufacturer). He is responsible for the CE marking of the product.
- The one who receives the product from outside the EU normally is the first one in the EU and imports the product. Now, the requirements as outlined in the MDR really are mandated only if indeed he sells the product to another entity. In that case he needs to make sure that the product he provides is safe etc. The requirements in the MDR are a relief because it limits the responsibility. However, he can do the exact same thing trade wise as a distributor. Trade is not limited. He can sell to the patient, hospital, a person or another legal person. This entity is the Importer according to the MDR. He, per definition makes the product available for the first time on the EU market. Making a product available for the first time is also called placing on the market.
- Somebody who now buys the product from an Importer can sell the product to a patient, hospital, person, or another legal person. This now is a Distributor and is making the product available on the market.
All of this is based on the assumption that a medical device flow through a "normal" supply chain.
Conclusion: Understanding MDR roles becomes more tangible when we focus on the actions each entity takes in the process-actions that carry specific responsibilities and contribute to the overall safety and compliance of medical devices in the EU.
------------------------------
Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
Original Message:
Sent: 09-Nov-2023 03:46
From: Alison Dennis
Subject: EU MDR - Importer and Distributor
Hello
All the below messages are correct on the legal position.
Conceptually you might find it easier to think in terms of "distributor for EU MDR" and "importer for EU MDR", who have to be separate legal persons.
The confusing part of the EU economic operator regime is that as a matter of FACT a person undertaking the physical import could be a logistics provider who does not "place on the market" and therefore is not your "importer for EU MDR", and equally your "importer for EU MDR" could be acting legally as a distributor of the devices by taking title and selling on the devices, but they will not be the "distributor for EU MDR". Hence if you use the terms underlined above and think of these as distinct concepts for the EU MDR, there might be a little less confusion.
Best wishes
Alison
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Alison Dennis
London
United Kingdom
Original Message:
Sent: 08-Nov-2023 09:21
From: Anonymous Member
Subject: EU MDR - Importer and Distributor
This message was posted by a user wishing to remain anonymous
Hello folks!
Under EU MDR, can an importer also act as distributor? We have our Authorized Rep in EU who is also our importer.
Also, do we need both symbols - for importer and distributor on the artwork?
Thank you!