Explaining the Role of Importer under EU MDR

What is the role of the importer, according to EU MDR? The requirements for this role have changed since the new regulation went into effect in May 2021 and it's important to understand the extent and impact of these changes.

In this episode of the Global Medical Device Podcast, Jon Speer talks to René Van De Zande with MedEnvoy Global, a specialty solution for European regulatory compliance that offers importer representation services. In addition, René founded EMERGO in 1997, later becoming what's known today as EMERGO by UL.

Listen to this episode as Jon and René discuss expectations, criteria, and obligations for importers under EU MDR and how this role should be managed for post-market surveillance, tracking, labeling, translations, and complaints.

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Some highlights of this episode include:

• Only two economic operators can be held responsible for placing a device on the market - a legal manufacturer that resides in the European Union or an importer.
• EU MDR does not clearly define who is who in the supply chain when it comes to economic operators. Articles 11, 13, and 14 overlap activities, obligations, and responsibilities for authorized representatives, importers, and distributors.
• According to René, there are three kinds of distributors: 1. Takes on the role of importer, as well; 2. Capable of taking on the importer role; and 3. Refuses to take on extra liability as the importer.
• Conduct proper due diligence when selecting an importer. First, map out who is who within your supply chain. Are there multiple distributors with quality agreements in place? Are obligations properly addressed to be met?
• Importers and/or distributors should have a quality management system (QMS) that complies with ISO 13485 and MDR to fulfill obligations.
• Person Responsible for Regulatory Compliance (PRRC) and importers are definitely different. PRRC is within an organization, and importers are outside representatives hired to provide services.

Links:

René Van De Zande on LinkedIn

MedEnvoy Global

Emergo

Underwriters Laboratories (UL)

European Union - Medical Device Regulation (EU MDR)

Economic Operators Guidance Document

Medical Devices Directive (MDD)

EU In-Vitro Diagnostics Regulation (IVDR)

ISO 13485

Mutual Recognition Agreement (MRA) for Medical Devices

Greenlight Guru Academy

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable quotes from René Van De Zande:

“It’s here, and it’s here to stay. There are no delays - at least not for the MDR. Since May 26, it’s alive and kicking.”

“The role of the importer is a critical one because there are only two of the economic operators that can be held responsible for placing a device on the market.”

“The MDR has not clearly defined who is who in the supply chain when it comes to economic operators.”

“You need to do proper due diligence. First, you need to map out as a company, who is who within your supply chain.”

Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: On this episode of the Global Medical Device Podcast, I catch up with Rene van de Zane. Rene is with Med Envoy Global. You can check out more about Med Envoy, MedEnvoyGlobal.com. But the topic we talk about is the role of the importer, now that EU MDR is in effect. The rules have changed a little bit, the expectations, the criteria, the obligations of an importer are pretty important, especially with respect to managing post- market surveillance, labeling, translations, lots of things that are really important to factor in when you're choosing importers. And this is a service that Med Envoy Global provides. So enjoy this episode of the Global Medical Device Podcast. Hello and welcome to another exciting episode of the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. Joining me today is Rene van de Zane. He is the... Rene, what is your title? I know you're with Med Envoy, but I guess I should have asked you that before I hit record.

Rene van de Zande: No, not a problem at all. I'm one of the partners within Med Envoy, as well as the commercial director.

Jon Speer: Okay. And a lot of folks may know you from Emerge fame, and we maybe we'll talk a little bit about that at some point in time. But you've been in this space a long time, I mean, as far as medical device regulations and understanding the nuances, and one of the topics that's confusing I think, especially now that EU MDR is live, is the role of the importer and thought we could dive into that a little bit today.

Rene van de Zande: Yeah. Very good. Happy to discuss that with you and the listeners.

Jon Speer: All right. I know when the EU MDR and when that was first made available to those of us in the industry a few years back now, this whole idea of economic operators was introduced and it was a, at least for me, a head scratcher. Of course, I've worked with authorized reps and importers and so on and so forth over the years, but the EU MDR sort of changed things for a lot of these economic operators, so I guess that might be a great place to start. Specifically with respect to the importer, why does this matter with respect to the EU MDR?

Rene van de Zande: Yeah, I think just for the general introduction, obviously, yeah MDR has kept us busy for quite a long time. And it's such a major overall, obviously for directives, that we felt pretty comfortable within the industry. And then of course, because of a variety of reasons, including a fraud event that took place in France, obviously the rest is history, right? So it's here and it's here to stay. There are no delays, at least not for the MDR. Since May 26, it's alive and kicking. So there we are. And I think with regard to the role of economic operators, as you mentioned, the authorized representative is a well- known operator, the economic operator, well- defined. But that didn't happen overnight. We all recall, in the early stages of the MBD and the IVD, the role of the authorized representative was not as well defined as it is today. So it took time. And I think we're going to see something similar with the importer. However, I don't think it's going to take that long. It takes years before we see a guidance coming out, what exactly the role of the authorized representative is. So that to set the frame a little bit. I also think it's, as a result, it's new, the MDR. I think the overall intent of the regulator has been to ensure within the supply chain there's proper traceability of the devices. I think that was a challenge on the MBD that it was not always clear when there were vigilance events, recalls, that devices were clearly tracked. So I think that is one thing. The other thing is just to put extra checks and balances into the supply chain to ensure that devices are compliant. And particularly the role of the importer is a critical one because there are only two of the economic operators that can be held responsible for placing a device on the market. That is either a legal manufacturer that resides in the European Union, or it is actually the importer and all of the other economic economic operators, they are the only one that can do it. That is important because place in the market bring quite a bit of heavy weight, I think, on the shoulder of this particular economic operator as an importer. And we could talk about that of course in more detail.

Jon Speer: Yeah. Yeah. No, I just remember quite a few years ago, way before a EU MDR went into effect when the directives were still the law of the land, so to speak, I worked, worked with quite a few US- based companies who were of course interested in the EU market and they built relationships with some of the importers and some were better than others. And I know in some cases we would try to have a quality agreement in place with the importer that defined our responsibility as the manufacturer and their responsibility as the importer. And to your point, being able to maintain records of where devices were distributed and be a point of contact if in the event that there were some issues or adverse events and things of that nature. Some of these importers just told us to pound sand, and it's like, man, that was frustrating because what do you do? And I guess this is promising now that things are shifting a little bit, but I can imagine that this is creating quite the stir in the EU. I mean, there's been a lot of companies that have been serving in that role of importer for quite some time, probably that don't have the systems in place in order to do that. So what are you experiencing? What are you seeing?

Rene van de Zande: Exactly. And of course then the role of importer, or is directly linked to the distributors, because I think those were always considered to be one and the same. And actually under the MDR, they could be if there is no particular importer identified by a legal manufacturer outside the EU who is going to take on the role of importer and the respective obligations as these are clearly stipulated in the MDR under article 13 for the importer itself. So yes, in the old days, the MBD times, the distributors were also often importers, but now this, because the MDR has not clearly defined who is who in the supply chain when it comes to economic operators. And although there is a very clear overlap in the activities that you'll see, the obligations, if you look at article 13, the obligations importer compared that with the obligations of authorized representatives, as well as from a distributor in article 14 and article 11, respectfully, for the authorized representative. There is an overlap. So I think that was intentional. But I think from a company perspective, responsible for managing and controlling your supply chain and then the obligations that you now suddenly have as an importer or a distributor, because the authorized representative, as I said earlier, they are already quite aware of their responsibilities, even though they don't like the fact that there are jointly responsible for defective devices. Which is one of the reasons also why some of these economic operators do not want to be an importer. To your question, this is a little bit disturbed. One, I think the manufacturer, legal manufacturer outside the EU, is starting to realize that these responsibilities are critical to them when it comes to managing the supply chain, because it can come to haunt them. If these economic operators obviously are not aware of their responsibilities, the authorized representative as a written mandate, it's clearly stipulated that you must have one if you don't have a place of business in the EU. So that's clear. Now from an importer selection perspective, or allocation, the MDR does not specify and states that you must have an importer. But what is going to happen is that if you don't have an importer as legal manufacturer outside the EU, you don't appoint one or multiple because it's not with the authorized representative. You can have multiple importers taking on that role and that obligation. If you don't manage that, that means that by the defacto other economic operators, like the importer or the distributor, even the authorized representative potentially, or for example, a 3PL, a logistics provider could become defacto the importer. And that is challenging because, or that could lead to challenges for the legal manufacturer since they are responsible for post- market surveillance, for tracking of their devices as well, even though each economic operator has its own responsibility based on their obligations. From a tracking perspective, it still is challenging. So for a manufacturer to say, I'm going to just let this go. I don't really care. It's not my responsibility. That is a little bit too easy to say. And I think the industry is realizing that. Now when we speak to distributors, I would say there's three kinds of distributors, right? There's one that says, sure, I'll take on this role of importer as well. You want to double- check that because distributors, in nature which they are, they're sales organizations, they love to do anything they want to do as long as they can sell your products. So they'll take it. So you have to be a little bit more cautious and really determine if that's the case. Then you have the distributor who will say, you know what, we can handle this. And they may be because they're a good outfit. They understand already their own obligations as distributor under article 14, there's quite a bit of overlap. And they'll say, we'll take it on. And that they have the capability as well. And then you have the importer, sorry, the distributor says, absolutely not. We do not want to take on this role. There is the placement of the market's responsibility, right? It's directly linked to the importer. They don't want to take on that extra liability. The same can be set for an authorized representative. As I said earlier, they don't like jointly responsibility for defective devices, don't add now also responsibility for placing on the market on the authorized representative. So that all in all summarize, definitely something that a legal manufacturer outside the EU to reckon with at the site, how are they going to manage this? Then there is the identification, right? You need to identify the importer, like we see with the authorized representative on the labeling. Now there are options similar to the authorized representative, right? They can put it on the device label or the device, the device label, packaging label and/ or the instructions for use. Now, the importer goes one step further and also say it could be information provided or that accompanies the device. And there is definitely a lot of gray area about what is exactly meant by that. Is that a device slip or an invoice? Is it the packaging slip or is it the IFU that we believe coming out of the industry? And again, that is just a pain right now. And the belief, I think down the road, we'll see more guidance. Exactly what is intended and what is meant by the regulator and where where would they like to see the importer identified. We believe it is as deep as possible into the supply chain. Most likely all the way up to the end- user. Then of course, an invoice or a packing slip, may not be the best solution, but for now manufacturers, or let's say importers, you'll have the options where to place or identify it. Again, in the context of your question, that helps the manufacturer to think about it because the distributors, right, they can be obviously importers as well. But most companies tend to have multiple distributors in the channels. So as a result of that, how are you going to manage that? So that's more of a practical issue. So that's one thing to reckon with. Are you better off with selecting an importer, and that solely is going to take on that role? Because when you think about importer, we all know, first thing we think about importers, well they obviously take products from A to B, right? They bring it into the market. They also think about, okay, there's the fiscal responsibility as well, with VAT when you get into Europe. So those flows, the physical flow of products into the market and the fiscal flow. That's all it clearly understood. But now with the MDR, there is this clear article 13 with the obligations of importer that is added to it. So I think as a manufacturer, you do need to think a little bit about how to manage it since it has a consequence if it's not managed properly or not controlled properly.

Jon Speer: Okay. A couple of thoughts. The first thought is pre-EU MDR, I assume that there were importers that existed, but me as med device company, I may not have had to formally designate an importer. I may have relied a distributor. Is that an accurate statement?

Rene van de Zande: Well, the importer was not as clearly defined as it is under the MDR. Because now it has clearly defined obligations under article 13 that did not exist. The importer did exist, of course. If you look at the blue guide, it is a great reference tool to understand some of the terminology in regulations and directive on an EU level. Of course always has spoken of an importer and who is an importer. And there is also confusion about that because initially a lot of people think that an importer needs to take title of the product or need to take physical possession. The blue guide is very specific that that doesn't need to be taken. So right now the MDR, what it has done, what I said earlier, it has really identified economic operators in the supply chain with each has their respective obligations. Quite few of them are overlapping with the intent of traceability of devices, as well ensuring the device are compliant and the first person or the first economic operator, right? If you are a legal entity outside the EU, is the importer and the designated importer as you mentioned that technically it's right now, that is not how it is interpreted. That you must designate that importer because it becomes defacto if you do not have one. I think I've been trying to explain the best as I can, that a manufacturer really needs to consider to designate an importer, for all the reasons that I just mentioned.

Jon Speer: Which leads me to the next question that I had. You talked about, because me as med device company pre- MDR, I definitely needed distributors in place in order to, especially if I'm outside the EU, to distribute my product to point of view. So if this is new or news to me, then I may say, oh, well, I've already got my distributors. And to your point that there's three flavors, if you will, of distributor. The distributor says no way, I'm not taking on that responsibility of importer. One that says, sure, happy to do so. And I'm willing to comply and adhere to all the new rules and regulations. And the third that says, yeah, sure, we'll do it. But they don't know what they don't know. I guess, from a company perspective who, maybe say, oh, well, I've already got my distribution channels all defined. And so what sort of due diligence or qualification or audits or that sort of activity, what should I be doing as a manufacturer, if I want to keep the importer role with a distributor? Is an audit necessary, should I ask for some sort of credentials or certifications? What should I be asking for?

Rene van de Zande: Well, depends on which country the distributor resides. You may want to do an audit if it's Italy, Spain, great countries to visit. Right. But I don't think that should be the deciding factor whether you should audit. But no, I do think you need to do proper due diligence, right? First you need to map out as a company who is who within your supply chain. So if you have multiple distributors, okay, what type of quality agreements do you currently have in place with these distributors? Because I presume that you do have those. And then make sure that the obligations of the distributor, first and foremost, which is article 14, are properly addressed and being met right in that quality agreement. And if you turn the distributor also as an importer, right, also becomes an importer under article 13, that that is properly addressed in the quality agreement as well. So that is one way of doing it. Now you want to make sure that they have proper processes, procedures set from a quality system perspective, that they have a place because the distributor is also responsible, right, for tracking of the devices. So you want to make sure that that is addressed in that quality management system. The distributor, of course, is also on the frontline of potential receiving complaints, right? And those need to be addressed properly, which in most cases already was addressed in the quality agreement under the MBD. But again, something to really now focus on and make sure it's addressed because it's strongly emphasized now. Particularly if you turn your distributor also in an importer. It's a double whammy, right. Now, two articles of obligations under the MDR are going to apply article 13 and 14. So that's that. I think those are critical. So the PMS part of it, post- market surveillance, vigilance, complaint handling. All of those processes that obviously are replaced on the manufacturer's perspective. Also, you want to make sure that the distributor have that in place. So it's all connected because as I said earlier, this is obviously part of the critical intent of why these economic operators have been clearly identified and have each specified obligations is in regard to traceability of devices and ensuring that devices are compliant when placed on the market. And from an importer, the only thing that the consideration that manufacturers still needs to make is, okay, how can an importer, right, fulfill its obligations on article 13, right? It needs to ensure that the product is CE compliant. What does that mean? Particularly it relates to ensuring the products when placed on the market for the first time, that these are the same devices for which it has identified which products are compliant. It's just a CE certificate. There's a declaration conformity. The labeling is an order, including IFUs. Has proper translation has been applied? Because as we all know, translations of labeling, it's not new. It's not new.

Jon Speer: But still, big deal though.

Rene van de Zande: Very big deal and an expensive deal because it's also, by what time obviously do you make an investment in a certain market? And part of that investment is the cost associated with translations. And that has become a very important element under the MDR as we know, because the MBD was not as specific as the MDR is, right, where it clearly stipulates that you must ensure that the IFU is in a official union language dictated by the member states where you placed the device in the market. And of course you and I have run into that many times, I'm sure. That has always been a major challenge and manufacturers outside the EU, particularly the English speaking even though we know English as a word language, it doesn't mean that everybody speaks English. So that is one thing. And that perception or that idea that they believe it is, I think they really need to get rid of that idea. So you really need to do your homework of where you place devices on the market, and then identify what the requirements are in those specific markets, right? Because there may be certain markets, countries that allow English only for professional use. I can tell you that many of them, at this time right. It never has been. So, as you know, there's a channel through where you can try to use through derogation where you ask the member states to allow you to present informational labeling in English only. Not easy to get. So it's definitely an exercise that companies need to go through. Particularly with the MDR. We think it's going to be an additional item that really notified bodies and competent authorities are going to hammer on. That that is addressed properly. And we all know that companies have SOPs in place that address labeling and document control. But we also know that the enforcement by notified bodies, right, and the competent authorities, was not that strong, even though. So again, I always like to tell clients nothing has changed when it comes to the requirements as these exist on a member state level, when it comes to translation of information provided with the device and/ or labeling, particularly when it's for lay person use. But even for professional use, you need to know what the requirements are on the member state level. And now with the MDR to differences that it's been clearly emphasized, that you need to take a note of that. Secondly, the economic operators, in particularly the importer, has a responsibility to ensure that the labeling is compliant. With that, includes whether you have proper translations now. And this is something we have run into quite a bit, obviously as Med Envoy but we know our clients are running into, or the manufacturers are running to it as well. So it's back on the radar. It's always been there. But I think now it's something that is hard to try to justify not to translate, unless there's a clear mandate given by the member state that you can do so.

Jon Speer: Okay. Well, Rene, this is a great point to take a short break. I want to remind folks, I'm talking with Rene van de Zane with Med Envoy. You can learn more by visiting adenosylcobalamin, all one word, no hyphens or spaces, dot com. Medenvoyglobal.com. Rene, while I'm taking this break, tell folks a little bit about Med Envoy and the types of products and services that you provide.

Rene van de Zande: Yeah. So Med Envoy birth birth is really a result of the MDR. As my background, you mentioned that in the introduction, I was the former owner/ president/ CEO of Emerge Group for many years and sold the company to underwrite in 2017 and stayed with Emerge by UL through the end of December 2019. And I really thought this is the end of my tenure, almost 30 years being in regulatory compliance. And I was going to do something completely different since obviously I had the opportunity to do so, and got into food products and dating apps and all types of software products left and right. But you could see it didn't last long. I'm back here in my old world, which I do appreciate and actually missed, even though it was maybe six, seven months. So we started Med Envoy with two other partners, Edgar Ka steel, who also comes out of Emerge, who resides in our Dutch headquarters in the Hague, the Netherlands, and Stefan Tusche, who was a former managing director and partner with Boston Consultant Group. So I would say three old hands in the industry obviously got together. And when we looked at the MDR and particularly at the economic operators, I'm very familiar of course with the role of authorized representative, Emerge being a large provider. This also smelled like the same thing when I smelled it in the late 90s, that this was an opportunity maybe to provide a service and also an opportunity to provide a solution to the industry. Because we all know that regulators come up with these great ideas, right? When it comes to safety devices, etc, etc. But there are some practical challenges with it. And I think with Med Envoy, now we have creative service where we offer independent importer service. So different from the authorized representative, different from a distributor, different from a third- party logistics provider, who also doesn't like to act as an importer because of place from the markets. And we believe with this service we allow our clients to really control a little bit more their supply chain. Just the commercial challenges that comes along with the role of the importer, if you give that to a distributor, you need to provide certain access to documentation, which can be sensitive. Similar to why you would select an independent authorized representative. So we saw this as an opportunity maybe to step in with a company like Med Envoy, and we developed a surface where, we believe, we hope it's minimally invasive to the supply chain, right, of our clients. But we do believe we developed something that meets the intent of the MDR and particularly of course, article 13, the obligations of the importer.

Jon Speer: All right. I'm going to come back to article 13. You've mentioned that a few times and I have some questions. But before we do, also want to remind folks at Greenlight Guru, we have the only medical device success platform on the market designed specifically and exclusively for medical device companies by actual medical device professionals. We help you manage and establish a quality system, things with design or development, including design controls, risk management, as well as documents and record management. All those quality events that you're going to have to manage and maintain throughout the total product life cycle of all your products. I would encourage you to go check it out, www.greenlight.guru and learn more about the platform and the products and services that we offer. And if you want to know if our products and services can meet your specific requirements and needs, just reach out to us. Give us a call, shoot us a note. We'd be happy to have a conversation with you and see if we might be able to help. All right, so-

Rene van de Zande: I want to tell the listeners before we continue to talk, I'm not being paid for this. So just want to make that clear. But Greenlight Guru, obviously an excellent company, Med Envoy also uses Greenlight Guru's software platform. Again, me coming from Emerge, obviously a big provider over all those years in developing and implementing quality management systems, and we always been able to do that without a software tool. And trust me, we run into too many times that it was time for us to do it. And I'm always amazed that we were able to do it for so long without a software tool. But I know those days are gone and I genuinely mean that to any listener. If you are considering volume management system, or you have a quality system that is more paper driven, I think it's really time for you to look into a product such as Greenlight Guru, because it saves a lot of time and efforts, and it's also much easier to manage and much more effective. And cloud- based. A lot of our clients are spread all over the world with vendors left and right. It absolutely makes sense. So again-

Jon Speer: Appreciate you saying so. I appreciate that a great deal. I guess that is a great segue to a question that I have. True or false, does an importer have to have a quality management system that complies with 13485, as well as the MDR?

Rene van de Zande: Yeah. Although it's on the voluntary basis, right? You want to go ISO 13485, but no, absolutely. I think if you consider the obligations and how you need to manage and fulfill those obligations to do that as a distributor and particularly as an importer, you do need to have a good quality management system in place that helps to ensure that devices placed in the market are compliant. So it has a strong verification element to it, right. So that's one thing. The other thing is that you're tied into the post- market surveillance part of it. And vigilance, when you look at an authorized representative, the distributor, but also in particularly the importer. They have an obligation to ensure that if there are problems with a device in the market for which they have been responsible for placing in the market, that they take appropriate action. And that will go all the way up to contacting a competent authority. So again, this needs to be streamlined and well- organized and manifest. So the best way to do that, to have a proper process in place. Then the other thing is, as an importer, obviously as it had been talked about earlier, is identified somewhere in the supply chain on information on the device. That means it can receive complaints and has clear obligations under article 30. One, to collect complaints if they do come in. Of course they have to channel that directly to the manufacturer. But they also need to have access to complaint records of their client or the company that they represent, or the device that they represent. Sensitive topic, right? How do you do it? But again, quality systems, right, are very important that they tie into each other directly with the manufacturer site and in your own quality managed system. So absolutely. There are a lot of reasons why in order to meet as an importer to your obligations of article 13, that that should be controlled and organized around a robust quality management system.

Jon Speer: Okay. So my question on the article 13, the importer has to meet the obligations of article 13. Who gets to determine that, do you as importer get to say, yeah, we went through a checklist and we've done that. Does it require that the competent authority to say so, does it require an auditing organization? How do you determine whether or not you as an importer have met those obligations?

Rene van de Zande: Yeah. So right now the importer, of course we're going to presume, that they will be considered a critical supplier in which case the legal manufacturer. So that's one thing. As we've talked about it, doesn't say that you must advise on 13485. But it definitely talks to the MDR that distributors and importers need to have proper quality systems in place. Particularly if they take certain requirements upon them, with relation to the devices or the legal manufacturer. So what we think is going to happen, so from an enforcement perspective, it's definitely the competent authorities, maybe notified bodies. We all know notified bodies love to audit. We all know how they're very busy. So they're a little bit selective of where they're going to audit, but everything when the dust settles, right, over time. But I think the importer will end up on the critical supply list of the manufacturer that they represent. And then of course, it's up to the critical, or to the legal manufacturer how they are going to inspect them and audit them, right? And if you look at the role of the importer themselves, right, that products placed in the market are compliant, which technically is associated with each shipment, right? Each shipment that enters in the EU, whether you take physical possession as the importer or not, you still need to go through a verification process, ensuring that the products placed in the market are compliant. So there's a process behind that and what happens, there's record creation. So it's the importer that needs to show and prove that it's fulfilling its obligations on article 30 towards enforcement authorities, right. It could be a notified body, but even more importantly, it's going to be the competent authority, like a company like us, Med Envoy. We know that at some point in time, we get a knock on the door in the Hague, and it's not far for the Dutch company authorities knock on that door. They can take the bicycle. Across the street, right. So that is going to happen. And so that's where really the enforcement will come through. Obviously, once products are placed in the market, it's up to the competent authorities to check and make sure that the economic operators are fulfilling their obligations. So that's what's going to happen.

Jon Speer: Okay. That makes sense. A new term that was introduced with the EU MDR is this term" person responsible for regulatory compliance" or PRRC. I know our industry loves our acronyms. So I guess, compare and contrast a person responsible for regulatory compliance and an importer, are these the same entity or are they different?

Rene van de Zande: No, they're definitely different. I mean, they all have to do with some part of compliance. But the PRRC, depending on the size of your company, obviously is an appointed person or persons within an organization. So within the legal manufacturer. So often, most likely within the RA department and/ or QA or a combination of the two. It's simply appointed person within an organization that is really ultimately responsible, but compliant, from the compliance, from an MDR perspective. So it's an important role. It needs to be taken seriously. And the MDR also protects the PRRC as a result of it. So it needs to be able to scream, right, to management if there are issues. It needs to have the ability to say, we cannot place this product for the market, right? We can not ship this product. So it's all of those things and the company can not have any repercussions-

Jon Speer: So they could be a protected whistleblower, right, without ramification?

Rene van de Zande: Correct. Of course the whistleblower is worst case scenario, right? Because that is when thing really goes down the drain and the management is not taking any proper action. But it's just in the normal daily activities of a regulatory affairs person, this case the PRRC, to ensure their products are compliant. It's those type of things. It really has quite a bit of leverage. And it needs to have given that leverage that mandate. And as at same time, but it needs to also obtain the protection. So the importer at this point does not need to have a PRRC, which is a requirement as an authorized representative, right? As one of the economic operators, the authorized representative, because when you compare, even though the importer has some compliance, of course, obligations, towards the device and the manufacturer that they may represent, of course, it's the authorized representative has clearly written mandates responsibilities. And the MDR now has required that the authorized representative internally, same as the client, which is a legal manufacturer outside the EU, each have their PRRC. So it's a very specific role. Now, when you're a smaller company, you can outsource that, right. So you can use, say consultants to take on that role. So that's the difference between the two.

Jon Speer: Okay. The last thought that's on my mind, in the moment anyway, is going back again to my past, I know we would set up several different distributor relationships throughout the EU. A lot of times distributors would have different territories or countries, specific focuses and things of that nature. Is an importer the same way? Can I hire or work with one importer to represent me throughout all of EU? Or are there some countries that require certain nuances or criteria for those importers?

Rene van de Zande: No. So you can have multiple distributors acting as an importer, or you can have one.

Jon Speer: Okay. Any or all of those combinations.

Rene van de Zande: Any or all. And of course being a little bit selfish, that's subjective, kind of. The reason Med Envoy exists is because when you do have multiple distributors, it gets definitely a little bit more challenging.

Jon Speer: Super challenging.

Rene van de Zande: If you allocate each one of them as an importer or even one of your distributors becomes the importer, which is because they need to be identified on the product information. As I mentioned earlier, somewhere along the supply chain, a little bit of gray area where it should be placed. But that doesn't work very well with a commercial partner like a distributor.

Jon Speer: No, because you don't want to have 15 different versions of labels because then it's a logistical nightmare to figure out where the product's going. So that makes sense.

Rene van de Zande: Yeah. Or even if you pick one distributor as your importer, the other distributors don't like to see a distributor being as the sole importer, identifying on the product information, right. So even though they may not have any territorial rights, contractual rights to sell anywhere else, but that was the same with the authorized representative. It just doesn't work.

Jon Speer: Right. And so that's the, not secret sauce per se, but the differentiator, I guess maybe that of Med Envoy is, hey, we don't want to be distributors. We want to be importers. So you can keep all the relationship with your distributors. We'll take care of the compliance for article 13 and all the other applicable language and labeling and all that sort of thing. That makes a lot of sense.

Rene van de Zande: Correct. And let your 3PL, your logistics provider, will do the fiscal. And often also your distributor does that. Just one thing that I forgot to mention, of course there are also companies that sell directly from outside the U to end users end, right? You can think about software downloads and everything else. So based on my, even though I'm a history major, I don't come from law school, but when I talked to some legal scholars, obviously so far it seems to be that the end user can not be responsible, can not be an economic operator. That's of course poses a little bit of a challenge, right? If you sell directly to this end user, which would be a hospital or a patient, right? So when you do that, now there is no importer. But there needs to be somebody responsible for placing on the market. If you're a manufacturer outside the EU. So therefore that's I think the only times where you really can ask, no, you do need to designate one, because this end user cannot be an economic operator. They cannot be importer. Does that mean now there is no importer? We're not part of that school of thought. We think now you do have an issue. And therefore, again, the reason why we believe Med Envoy was a good alternative to make a little commercial pitch here for our services.

Jon Speer: Yeah. For sure. Rene, I've picked up a lot of good nuggets and quite a bit of information that I didn't know about prior. I'm glad that we took some time to chat about the role of the importer in the EU and with respect to the MDR. Is there anything else that you think is really important or maybe another tip or pointer that you want to offer our listeners before we wrap things up today?

Rene van de Zande: No, I think we need to stop somewhere, right? Because we can talk for hours and hours. If we think about Switzerland as well, right, because when you think about Brexit, right, that is something maybe I want to leave as an important thought as well for the listeners. If they have no thoughts about it, that we all know with Brexit, the nightmare that evolved over the last couple of years with seeing countries leaving the EU, which obviously happened with the UK. As we all know, you need to have a responsible person because the UK is not considered a third country like the U. S. and Japan, through the eyes of the European Union or the Union. So you need to have that responsible person, which is the equivalent of an authorized representative, European authorized representative. And you also need to have an importer in the UK, even though not clearly defined yet what this role of the importer is. We anticipate that it's going to be very similar to the MDR importer. So that's one thing to consider. The other thing is Switzerland, which is our latest, greatest disappointments that we as the industry have to endure right now, which is, as we all know, they were working on their legislative framework, was supposed to be the mutual recognition agreement that would cover the MDR since the MBD as of May 26, obviously it's gone. So obviously that didn't happen. So now we have a similar situation without the MRA, which are recognition agreement. Now Switzerland is a third country. It always was, but without the MRA now it means that you need to have an importer in Switzerland, as well as a Swiss authorized representative. And there is a little bit of time. There's no immediate panic right now. There's clear timelines defined when you need to have a Swiss AR mandated, so registered. Still some question about device registration. Since, as we all know, the Swiss were part of the MDR and were going to UNAMET. Now that has disappeared, so with waiting a little bit to get more guidance from Swiss medic, what type of registration they will require. So that's my last, it's not a positive thought. Hopefully it's a good thought that at least companies are aware of it.,

Jon Speer: Well it's complicated. I think the point is it's complicated and it's very fluid and dynamic. And me as a company based outside of the UK, Switzerland, or the EU, there's some homework and due diligence that I should be doing as far as which of those regions requires an importer, which requires an authorized rep, etc, etc. So I think that's loud and clear. And I guess, fortunately for folks like you and I, because of these dynamics, we have lots of opportunities to try to help people navigate this because it's complicated at times. And don't assume that you can just figure it out. I mean, you might be able to, but Rene's has been doing this for quite a few years. I've been doing this for quite a few years. These are our skills. These are areas of expertise. So lean on us.

Rene van de Zande: I remember your beard was still black.

Jon Speer: I know. Tell me about it. I saw a picture the other day. I was like, oh my goodness. It hasn't been that long. I mean, and the crazy thing is I'm in my mid 40s and I was talking to my dad the other day. And I think my beard is more white than his and you know-

Rene van de Zande: Blame the MDR. We all do. Blame the MDR.

Jon Speer: Blame the MDR. We'll let that be our final word. Rene, thank you so much. Rene van de And, partner at Med Envoy. You can check it out, Medenvoyglobal.com. Definitely the type of resource that you want in your corner. If you're outside the EU, even if you are in the EU, there might be some opportunities for the Med Envoy team to help you with market opportunities and the UK, Switzerland and throughout the EU. As always thank you for listening to the Global Medical Device Podcast, the number one podcast in the medical device industry. And that's all because of you, our listeners. And you can also watch the episodes now. We've been recording these on video. So check those out on YouTube and through the Greenlight Guru blog and that sort of thing. So check that out. This is it. Wrapping up this episode of the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. And you have been listening to the Global Medical Device Podcast.

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