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The new medical device regulation in the European Union (EU MDR) has introduced a host of new challenges for medical device companies. One challenge, in particular, has to do with the quality management system of a medical device.
In this episode of the Global Medical Device Podcast, Jon Speer talks to Monir El Azzouzi, founder and CEO of Easy Medical Device. Also, Monir is a prolific podcaster, blogger, and YouTuber that helps medical device companies achieve compliance.
Together, Monir and Jon discuss the ways in which EU MDR impacts a quality management system and best practices medical device companies can follow to maintain compliance with new requirements.
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Some highlights of this episode include:
- Medical device manufacturers have several QMS standards, regulations, and frameworks to follow, such as ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
- Rumor has it that the FDA is harmonizing its Quality System Regulation (QSR) with ISO 13485:2016. Why? FDA’s QSR and ISO 13485:2016 offer significant similarities toward harmonization depending on where medical device companies, manufacturers, and products are located (in the United States or European Union).
- EU MDR implementation involves a complex transition process, it’s not about simply updating a technical file.
- What are the differences between ISO 13485:2016 and EU MDR? Refer to Article 10.9 for process requirements and Easy Medical Device courses.
- Research notified bodies to determine and verify authenticity, authorization, and accreditation.
- QMS changes related to EU MDR place greater emphasis on clinical and post-market surveillance as well as risk/benefit management. Be proactive!
- When everything goes well, nobody rechecks what you are doing. As soon as there is an issue on the market or there is a competitor that may want to raise some concerns, then the authorities can come and visit your site.
- EU MDR: Will it be delayed or postponed again due to COVID, remote audits, or because it’s too difficult to implement? MDR is a chance to level up and raise the bar in the medical device world.
Links:
Easy Medical Device
Easy Medical Device on YouTube
Mini-Course EU MDR
Green Belt Certification Course
European Union Medical Device Regulation (EU MDR)
EU IVDR
FDA Quality System Regulation (QSR)
ISO 13485:2016 - Medical Devices - Quality Management Systems
ISO 9001 - Quality Management
FDA - Medical Device Single Audit Program (MDSAP)
Regulation (EU): Article 10.9
Checklist for General Safety and Performance Requirements (GSPR) compliance
EU MDR Notified Bodies
Brexit Transition
EU MDR & IVDR True Quality Summit Series powered by Greenlight Guru
Greenlight Guru YouTube Channel
MedTech True Quality Stories Podcast
Greenlight Guru
Memorable quotes from Monir El Azzouzi:
“A quality management system is not just a bunch of documents.”
“When you are, for example, manufacturing some medical devices, you have to respect some rules, some regulations.”
“Don’t pay something twice (choose certification vs. notified bodies wisely).”
“EU MDR is a regulation that is...raising the bar in terms of requirements and things that you need.”
“When everything goes well, nobody will recheck what you are doing. But as soon as there is an issue on the market, as soon as there is a competitor that maybe wants to raise some concerns, then the authorities can come and visit your site.”
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: I really had a good time on this episode of the Global Medical Device Podcast. I got to talk with Monir El Azzouzi. Monir is with Easy Medical Device, and he is a prolific podcaster and blogger and provides a lot of great content. He has a lot of expertise to offer and share on EU MDR. This episode of the Global Medical Device Podcast, Monir and I talked about some of the pros and cons or I guess some of the finer points of the EU MDR and how this might have some impact on your existing quality management system. So, enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer, and joining me is somebody that I've been a fan of now for a bit, and it is Monir El Azzouzi. Monir is the founder and CEO of Easy Medical Device and also a very prolific podcaster. I guess it's the right way to describe it, but Monir, welcome.
Monir El Azzouzi: Thank you, Jon. Yes, podcaster, Youtuber, blogger, so there. There is a lot that's got to be considered. Yeah. The idea is mainly to help medical device companies to be compliant, to place compliant devices on the market. And this is really the mission that I'm trying to have, and also to share on all my videos or the podcast that I'm doing here.
Jon Speer: Yeah. And Monir has done, how many episodes have you done now?
Monir El Azzouzi: Yeah. I've done, for now, it is 111 episodes- crosstalk
Jon Speer: Oh, my gosh. Congratulations.
Monir El Azzouzi: I remember I think last year you have reached the 100 crosstalk mark. You at the GreenLight Group. And we were talking about that and you said to me,"Yeah, I wish you really the 101." And when I reached that, so I was really happy, so, yeah. crosstalk Thank you so much for that.
Jon Speer: Big deal. I can tell you love it and you put a lot of work into it. Your work shows, and folks, go to easymedicaldevice.com. I mean, how easier can a domain name be to remember than Easy Medical Device. Monir provides a lot of great content. I've used a lot of the guys and the information that he has to tell me better understand some of the topics. But today, when I was talking with Monir the other day, he thought, there might be an angle here, we could talk a little bit about EU MDR and QMS. So, I thought we'd dive a little bit into that today. Monir, if you want to give people, I guess, a starting point. Maybe a good place to start is just remind everybody, hopefully, but for those that may not be familiar, what is a quality management system?
Monir El Azzouzi: Yeah. So first, we have to understand that a quality management system is not just a bunch of documents because sometime, I have some customer that comes to me and say,"Oh, create me my quality management system and so, send me all the documents and I would show that to the regulators, et cetera." But for me, creating a quality management system is more of a mindset or as I call it, usually it's the law of your company. Like you are creating some laws for a country, so they have to follow. So, it's the same for companies, how they can design a product, how they either reserve a compliance, how they will manage it, et cetera. So, it's really creating the law of your company. And this is really what you have to have in mind for when you create your quality management system because it's a lot of work, a lot of documents, you have to maintain it. So, it's not like theories of just a bunch of documents and then you are done. No, it's like something that you have to maintain and to execute and to improve. Yeah. This is really the system or the law that should be used for your company.
Jon Speer: Yeah. The word that some people may just cringe at, maybe is the law for your company, that law where it scares people. But I think it's really important for people to understand. Another word that sometimes is used is governance, regardless of what word you use, this is setting up the infrastructure or the framework within your company. And I think the key thing there is, compliance is still an important aspect of being a medical device company. So, these are the laws on how you're going to demonstrate and address that. Obviously, many are, there's been well in the U.S., we have the FDA QSR. There's a few different ISO standards along the way as well. I think probably the most common is probably 9001, which I don't even remember when that originated, but obviously, in the med device, we have 1345 and for all intents and purposes, these are similar and, provide a good framework, but I guess, where are they the same? Where are they different? And I know that's a big question. So pick and choose the big points that you think are relevant.
Monir El Azzouzi: Yeah. So at a certain point, for example, the other ISO 9001 is a general quality management system. So, it's something that a company that is manufacturing some furnitures or things that we are using consumable that we are using can use, if I can say it, to set up a quality management system. So, it's really general. It has no really specific topic on anything, so it's can used by even services company. So, for example, I have my consulting firm and actually we are trying to set up an ISO 9001 system because we are not a medical device manufacturer. We are just a consulting firm, so we are trying to go through that path instead of the other. When you are a medical device manufacturer, so the best quality management system is the ISO 13485 and mainly, this is for example when you are, for example, manufacturing some medical devices, you have to respect some rules and regulations. And there is also some harmonized standard that you have to follow. And mainly for quality management system for medical devices, the harmonized standard is the ISO 13485. The QSR, so it's mainly the one for the U.S. But for me, a QSR and the last version of ISO 13485, so the 2016, are nearly similar. I even heard that the FDA is thinking now of replacing QSR by ISO 13485, but I don't know where they are on their journey for that. So this is, as you mentioned, some frameworks or some, some way to do it, but I'm always saying, if you want to establish your own quality management system without following this, you can. You just have to prove that all what you are setting up is really compliant to the regulation and to all the requirements of the regulation, which can be really difficult with some auditors. So, my best advice is really to follow, for example, ISO 13485, if you're a medical device company and not try to reinvent something that is already existing.
Jon Speer: Yeah. I think that's good advice. And to your point, the rumor, I guess that you've heard about FDA movement to QSR, are from QSR to 13485. I've heard that same thing several times. In fact, I've talked to some folks that are relatively close to FDA and on this particular topic. And I think the latest that I heard was that we should expect some movement from FDA as soon as February of 2021. Now, that's right now, so I don't know if that's going to be the date that happens. But yeah, I do think we should start to see that transition. I think you raised a really good point. I mean, when 2016 version of 13485 came out and always 13485 and QSR have been pretty close, but the 2016 version made some giant leaps forward towards harmonization. And at least from my context, my opinion, the FDA QSR hasn't been updated since it was published back in 1996, whereas the ISO framework is more dynamic. There is a group of people who work on this and revise it every so often. So, I think this is one of those things that FDA has realized and FDA participates in that group as well.
Monir El Azzouzi: Yeah. And the thing here is what is important, so I participated to audit in Europe for FDA and for ISO for notified bodies. And companies in Europe don't have two systems. They don't have one system for FDA and one system for ISO 13485. They have one system for everything that is compliant with both. So at the end, it's not like you are following two different rules. You have just to take the requirements for both and to create a procedure. Sometime I have a procedure that says, if you are selling your products in Europe, here is the process to follow. If you are selling the products to the U.S., here is the process follow, because there is some small differences. But in majority, for example, for CAPA system, I don't have any specific requirements for ISO 13485 and another one for QSR. So, it's exactly the same thing. So yeah, there is a lot of similarities and only a small differences, but we get a lot of similarities. So at the end, yeah, let's have one system instead of- crosstalk
Jon Speer: For sure. And folks, if you're a startup company that's building or establishing your first QMS, this is what we do for a living. Both Monira and I, we have a lot of expertise in establishing quality management systems. So, depending on where you are or who you prefer, or whatever the case may be, you can reach out to either of us. And we can, we can certainly help you on that. You can find monir@easymedicaldevice.com. You can find out more about Greenlight Guru by going to www.greenlight.guru. Alright. So Monir, for the past, let's go with five or so years, the medical device industry has been, well, there's been a lot of changes. I mean, we talked about 13485. We've had ISO 4971 has been updated. There was the medical device single audit program for some parts of the world, probably forgetting a few, but obviously EU MDR is now just, it's just right around the corner. This is yet another change that impacts a company's quality management system. Good news is 13485 and the QSR are pretty much in sync, but is EU MDR going to create some new challenges with respect to quality system?
Monir El Azzouzi: Yeah. And it's always kind of a surprise for some of my customers because they come to me and they say,"Okay, I want to transition to EU MDR." And they say,"Okay, can you provide me a technical file for that? I mean, update my technical file for that crosstalk?" and I ask them,"Okay, and what about your quality management system?" And they all say to me,"Oh, but we are ISO 1345, so it's fine. It's okay. There is no chance to be on this and that." And I say,"Be careful." I mean, it's not like you are ISO certified and everything is fine. It's more like EU MDR is implementing new rules for some procedures that you have on your ISO 13485 and even it's creating new requests for new procedures that you don't have on ISO 13485. So at the end, you have to be careful to not just focus on an update of your technical file, because there is a need for a bit of your technical file for EU MDR. But also to start from first starting with the quality management system, and then move to the technical file to start with your quality management system, to make an assessment of what are the differences between what you have actually, and what the EU MDR is requiring. And for that, there is a specific chapter that you have to look at, which is the Article 10.9, where it says specifically,"Here are the procedures that we want to see within your quality management system." And one thing that is important here is that when you will read this article, there will be a listing of procedures or requirements. For example, the first one is we need to have regulatory compliance procedure. Mainly, this is not something that is existing within the ISO 13485, so you'll have to create that. So, it's a procedure that is telling specifically all the requirements for EU MDR, the classification of your products, conformity assessment. I mean, a lot of things that are not mentioned in the ISO 13485. So, this is for example one of them. The second one is GSPR. So, GSPR is the new version of the essential requirements. So before we call that essential requirements, now we call that GSPR, is also something new, and that can be also included on your regulatory compliance. There is also other procedures that are already existing within the quality management system, your quality management system, but, you have to update them. So it's not like you are just to keep it as is. For example, the clinical evaluation. A clinical evaluation, it's a procedure that is already existing, so it's something that you had done before. So, it's not like new but the EU MDR is providing new requirements following, for example, Article 61 or Annex 14. So then, you will have to make a gap assessment between those two LMS. So, your procedures, so you read your procedure and you read the articles and you check if this is aligned. If it's not, then you have to update your procedures. So you have, for example, clinical evaluation, you have the UDI procedure or identification and traceability procedures. Some of the manufacturers call it like that. Your post-marketing surveillance procedure, your vigilance procedure, your communication procedure, because now you have also to include the communication with your economic operator. So, there is those procedures that are kind of existing, but you have to update them. And there is also procedures that are mentioned. That for me, I suppose, if you are already complying to ISO 13485, there is no need to change, which are, for example, the responsibility of management, the risk management, the product realization, the CAPA system, which are procedure that are existing, but there is no new requirements specifically due to EU MDR. So you see here, just my making this kind of listing, you see that there is a bunch of work that the companies have to do to update their quality management. I mean, first, to assess if there is any chance to do and then to update their quality management system, because a notified body will come and will check if you are complying to those requirements. And if you are not, then you will not be certified and you will not get ISO 13485 first, and then you'll not be certified. So, I advise you really to, to make this check and to really update the procedures, so that you are really compliant to the EU MDR.
Jon Speer: Yeah, absolutely. Monir, I want to take a quick break, remind people I'm talking with Monir El Azzouzi. Monir, tell us a little bit about what you're doing at Easy Medical Device and where people can find out more.
Monir El Azzouzi: So, inaudible So at the beginning, we started really to educate people. So more trainings through some blog, podcasts or videos. We created also the Green Belt certification training for EU MDR. So mainly every month, we have a session of one week where we invite people to come and to be trained, not on a theoretical basis, but train on practical basis because we are providing some assignments where it's coping. If I can say what we are executing for our customers in the real life. So, they will see really how they have to execute some of the tasks. And then, they get some quizzes. They get some live sessions with me where we can do some question and answers. And at the end, they have an exam to pass and if they get it, so then, they'll get the certificate. But apart of that, we are also doing consulting. So we are helping all the medical device manufacturers that want to transition from MDD to MDR or also new medical device manufacturers that are really trying to get their products on the market. I just have to tell that it's really difficult. Actually, we will not fight with the situation. First, because of the availability of the notified bodies. And so bond also, it's something that we start to discover, is because of the prices and that the notified bodies are charging, if I can say, to get certified. It starts to be higher than what we thought before. So, it's something that is starting to stop some of the startups to continue business. So, this is what we are trying to do in terms of other project but mainly, anything related to quality and regulatory affairs for medical devices. We are trying really to help on that. Just the last thing that we are also doing because of Brexit, so we have opened an office in the UK. So, two years of the UK representative for the people that are trying to sell their products in the UK. Because mainly, when you are going to the UK, you have now to have a representative onsite, which we know should not be somebody that's located in Europe because of Brexit. UK is not anymore in Europe, so then you have to have now two representatives, one in Europe and one in the UK. So then, we are helping also for being the representative for those companies. So yeah, here it is.
Jon Speer: Well, it's awesome work. I mean, I've gone through some of your courses and consumed a lot of your content and certainly on a EU MDR topic. You provide a lot of clarity and in folks at Easy Medical Device Podcast, you can find it on the easymedicaldevice.com website, but there's also a YouTube channel. Monir has done something that he does videos with all his podcasts. And it's inspired me to consider that with the Global Medical Device Podcast. Stay tuned soon. We might be exploring that as well. But while we're talking about quality management system and have this brief break, I want to remind you too that Greenland Guru, we're here to help. Greenlight has the only medical device quality management system software platform in the industry. It's been designed specifically and exclusively for the medical device industry, aligning with ISO 13485 and the QSR and the impending EU MDR and ISO 14971 and all the things that are important to you from a compliance perspective. I would encourage you too, if you're in a place where you'd like to gain some more efficiency and learn more about ways we can help, go to www.greenlight.guru. Some exciting news that we've been working on is incorporating some machine learning and some AI elements into a quality management system platform. We have a feature called Visualize, which allows you to see a picture of the relationship of all of your documents and records within your quality management system. And we are rolling out a new feature called Halo for Change Management. In fact, that was just announced the other day, but that's revolutionized things. It's going to make your change management practices so much better. It's going to feed you information about what should be incorporated in changes that you're making. That way, you can make sure you've crossed all the Ts and dotted all the Is. So again, go to www.greenlight.guru to learn more. Alright. So Monir, let's get back to the topic. One of the things that can be a little bit confusing I think, is this notified body and auditing organization and certification body. Are these all the same thing or are these different entities? Can you maybe provide a little bit of clarity about that?
Monir El Azzouzi: Yeah. So mainly, certification body is a company that is certifying you for certain standards. So, as we talked about ISO 13485, so a certification body that is listed on the website for accreditation can provide you an ISO 13485. So first, I recommend you, for example, if you are having some suppliers or anybody working with you that provides you with an ISO 13485 certificate, to not just trust the documents. But to go on the website of the accreditation bodies and to check if the certification body is really accredited for giving that to you. Sometime on their website, they have also a place where you can check the certificate. So, it's something that I advise you to do because following my research, I find a lot of certificate that were not really true, that mislead. I can see some of those manufacturers who say,"We are ISO 13485" when it's more like yes, they are, because they are maybe following the procedures, but they never got certified by an external company. They just have a diploma to say,"I'm following ISO 13485." But I'm not really satisfied and this is something that is sometime misleading. So, those certification bodies are accredited, so they are have the authorization to provide you an ISO 13485 certificate. But there is also something that is a bit misleading for some companies is the fact that when they are trying, for example, to get a C Mark, they are saying to me,"Okay, can I have a certification body that is providing me an ISO 13485 certificate?" And then later, I will get my notified body coming for the EU MDR. And the thing is that the notified body is the one who has to look at your ISO 13485, quality management system, and has to confirm that this is a system that is following this regulation. So, this is mainly what is written on the EU MDR. Some of the people that are trying to read that also interpret that. Yeah. But it is maybe a typo to say anybody that is accredited for that can do it. But after many discussions with the other experts, they said,"No, it should be a notified body." So the one that is really accredited for EU MDR should be also the one that is providing you the ISO 13485 certificates. So, don't pay something twice, if I can say. Meaning, having a certification body first that is coming to give you an ISO 13485 certificate and then, going with the notified body that will charge you again for that because they have to check that your crosstalk procedure is following the ISO 13485.
Jon Speer: Yeah. Choose wisely, I guess. Know where you want to go and what you want to get into. But you know, if you're going to have your company go through the certification process from a quality system, I'm going to guess you're going to bring products to market too, so just choose wisely. Monir, I mean, anything else? I mean it hit on a moment ago. Maybe we can talk a little bit more about this. Some of the changes or things that you should explore from a quality system perspective because of EU MDR. I mean, there's a lot more emphasis on clinical as you noted and not just clinical, but I think all the post-market clinical activities that are expected from my perspective too. I think there's a lot more emphasis that's put on post-market surveillance. Another theme that I picked up when I read the EU MDR is a more emphasis on risk and risk management and risk-based approaches and things of that nature. You've been working through with a lot of companies through the transition toward EU MDR. What are some of the things that you've seen as more challenging than others?
Monir El Azzouzi: Yeah. So, the EU MDR is a regulation that is if I can say, raising the bar in terms of requirements and things that you need. For example, before with the MDG, we had for example, some Class I devices company that were, because it's self-certified, that are just providing their products on the market without having a quality management system or review a minimal quality management system. But on the MDD, it was not really clear at all that they needed, If I can say something like that. But now, it's written black and white. If I can say on the EU MDR that any company that is bringing a device on the market should have a quality management system. And it's why this Article 10.9 is important because it's showing to you what is the minimum requirement that you should have as a company to be qualified or to be compliant to EU MDR. So, it means that maybe your company is trying to place some Class I devices, which are self-certified on the market, but at a minimum, you have to have the procedure that are listed from Article 10.9. Even if you are not ISO 13485 certified, you have to show those procedures. What I'm always saying is that when everything goes well, nobody will really check what you are doing. But as soon as there is an issue on the market, as soon as there is a competitor that maybe wants to raise some concerns that inaudible then the authorities can come and visit your site and ask for some details from some information before maybe they can say,"Okay, you are not really compliant, so we'll stop your certification or your registration of this product on the market." So it's why here, there is a minimum elements to have on your quality management system and Class I devices, even if it's self-certified, even if it is low risk, have to have some procedure, so have some quite management systems. So this is, I think the first thing that is really important. They also have to have a clinical evaluation, even if it is a low risk product, because I have a lot of companies that come to me and say,"Oh, I don't need a clinical evaluation report because I'm Class I, I'm low risk." No, you have to have one even for that. And I have made a specific podcast episode on this type of low risk devices, the post-marketing surveillance. I think this is something that is also surprising for some companies is the fact that before, when we were doing the post-marketing surveillance, we're, if I can say, waiting for the information to come to us, like a compliance, like a literature, like an expert suggestion or comment or whatever. So, many we're waiting for that. Now, the regulation is clear that you have to be proactive. So it means that you have to go to the market to initiate some studies like a PMCF, or to initiate some survey, or you have to do something by yourself to plan something by yourself, to go to the market and to gather those data by, you should do that. You should not wait that somebody is coming. So, here are some examples of elements that were, if I can say accepted within the MDD, but are not any more accepted within the EU MDR and you have to do something with it. So, this is just a small list, but yeah, there is more that can come here.
Jon Speer: Yeah. And here's another question that I get a lot. I mean, obviously the original date that EU MDR was supposed to go live was in May of 2020, and probably for obvious reasons with the pandemic, that was pushed out until May 2021. So, the question that I get often is, will it be delayed again? I have an opinion about it. What is your thought about that? Yeah. It's funny. So just for the story, I've known that my podcast since many years now or some two years now, and I have with me a famous lawyer in Europe, which is called Erik Verbrek. So, we always talked about the fact,"No, the MDR will not be postponed. No, the MDR will not be postponed because it's too difficult by law and they have to vote and this and that." And when there was this pandemic, it was,"Oh, it's postponed." It was easy. I was discussing with Erik Verbrek and I asked him,"Okay, now, what should we say to people?" Because we are saying that since one year, that"No, it will not be postponed. Now it's postponed." With those circumstances and we are really happy that it's postponed because mainly, it gives more time for some manufacturers. And also, the notified bodies to satisfy some products. But the issue of the postponement is the fact that the pandemic is also something that, if I can say, delayed certification, because notified bodies couldn't travel to go to audit their manufacturers because on the regulation, the EU commission says you cannot certify a company with the EU MDR certificate without doing an onsite audit. So then, all notified bodies were nearly blocked. Some could do continue to do the audit because they had an office maybe in the country where the auditor, where the manufacturer is placed. And they had the auditor that is qualified for specific-released product. So then, they had the chance to continue on the process. But, a lot of them were not able to do the onsite audit, so then they were blocked. The manufacturers couldn't move forward. They had to wait for this pandemic to be stopped, so that they can move forward. During that time, the notified bodies raised, the question is to the EU commission to say,"Please can you authorize us to give the certification with the remote audits?" And during the long time that EU commission says,"No, we don't allow that." They provide even a MDCG guidance to say,"No, it's not possible. You can do remote audit, but remotely is not authorized for a new certification, et cetera." And suddenly two weeks ago, or last week, I don't remember, the EU commission says,"Yes, it's fine. Now, you can do remote audit for a first certification in under certain conditions again that the products are really critical, that there is really no possibility, et cetera, temporarily." So, they say that temporarily they can do that. So, this means that normally from now, the notified bodies can start to have some remote audits with their manufacturers, which means that normally, if this is done correctly, there is no possibility then for postponing the May 26, 2021 date of application launch because they authorized remote audits. And it's what's they are saying. So, we have a bet actually with crosstalk Verbrek to say that for me, I say, there is still a possibility. So, maybe then it will be postponed. And Eric says,"No, it will not be postponed." So I said,"Okay, so let's have a bet." We have a champaign bottle bet. So, crosstalk if he wins, then I will have to pay a champaign bottle inaudible I get it. So mainly, we will see, but to be honest, my conviction is that there will be no delay, no postponement of it. Yeah. And regardless, I don't think if you're a medical device company betting on another delay in the EU MDR, then you're looking at this from the wrong perspective. I mean, look at the MDR for what it is. It's a chance to level up to raise the bar. I think it was the words that Monira used earlier. And that's really it. I think it creates a lot of anxiety with folks at times because the previous version, the MDD, that was authored back in the 90s. A lot has changed in the 20 plus years since the EU MDR came out and it's going live. A lot has changed in my world in 20 years. I'm guessing the same is true for you and certainly, there has in the medical device world as well. So, this is just an opportunity to level up our companies, our practices, our quality management systems. And one other thing that many, we'll have to talk about this on a future episode, I think a lot of people are forgetting is the EU IVDR is going live in a little over a year or so in May of 2022. And we'll talk more about that on a future episode, but anything else that you want to leave the audience with today on EU MDR and the quality management system as we wrap up this episode?
Monir El Azzouzi: Yeah. As you mentioned, just an idea because it's a picture I'm showing to, to some of my students or participant, to my training. So, the MDD has 60 pages. The AIMDD, which is the active implantable medical device directive has 20 pages. So, it makes it 80 pages in total. The EU MDR is 175 pages. So, more than the double. crosstalk So, just by showing this picture, you can see that the requirements are huge. There is more requirements within the EU MDR than within the MDD and the AIMDD combined. So, it's more the picture that I am showing to people just to make them understand that it's not just a small change that, because I have some companies that are coming to me and say,"Oh, here is all the chance that we have to do and here is the invoice that we'll charged for that." And they are saying starting to, I can say, beg, because they say,"Oh, it's that much?" And I say,"Yes, because I don't think it's just one document or two document to change. It's a huge number of documents. You have to redo some clinical evaluations. You have to review, as I've said, all your quality management systems. So, there is a lot of things to do here, it's not like just a small change. So, if you have still not started on this project, I really advise you to do that immediately. Or you can lose a big market. So, the EU is really a big market and you can really lose that."
Jon Speer: Yeah, for sure. Monir, thank you so much for taking time to share some of your thoughts and insights on EU MDR and quality management system today. I appreciate you being a guest on the Global Medical Device Podcast.
Monir El Azzouzi: Thanks, Jon. Really, appreciate it.
Jon Speer: Yeah. Folks, again, go to easymedicaldevice.com. It's really that easy. Check out all of the exciting content and videos and podcasts that Monir does. He gets some experts from all over the globe, talking about the things that are important to our industry. It is a really great podcast. I have to admit that I feel like there might be a little competition going on, but it's a friendly competition. Both Monir and I are of the same purpose with these podcasts. And that's trying to educate and inform you about topics that are important to our industry. So, you should listen to his podcast and you should also listen to the Global Medical Device Podcast. But as always, we're here to help too at Greenlight Guru. Again, I've shared with you today that the Greenlight Guru Medical Device quality management system software platform is designed for you by the medical device professionals. So go check it out, www.greenlight.guru. And as always, thank you so much for being a loyal listener of the Global Medical Device Podcast. Continue to share this with your friends and colleagues, and we'll look forward to catching up with you again real soon.
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