The end of 2020 is near, which will close out a year that’s been fraught with challenges and difficulties. However, 2021 will bring its own set of new challenges for those implementing the European Union Medical Device Regulation/In-Vitro Diagnostics Regulation (EU MDR/IVDR). What do device companies still need to do to be prepared for the transition?
In this episode of the Global Medical Device Podcast, Jon Speer talks to Bassil Akra, CEO and Co-Owner of QUNIQUE Group, a quality and regulatory consultancy. Bassil offers expert advice on how device companies need to prepare for these regulatory deadlines and transition to meeting the requirements of EU MDR/IVDR sooner rather than later.
Some highlights of this episode include:
- COVID-19 is an additional burden by impacting implementation, increasing requirements, and not being transparent about limited notified body capacity.
- EU MDR/IVDR Readiness: Under the new legislation, every device needs to receive re-certification by notified bodies to keep market access.
- EU MDR/IVDR Challenges:
- Additional guidance needed during transition to apply these regulations.
- Regulations put expectations that are not ready, such as EUDAMED.
- Increased requirements on clinical evidence via higher clinical and performance evaluation requirements.
- Continuous reporting increases expectations on resources for new and existing medical devices.
- EU MDR/IVDR Timeline: Number of notified bodies isn’t the most important part. How much capacity do those notified bodies have to address market needs?
- Tips for Medical Device and In-vitro Diagnostic Companies:
- Read the regulation(s).
- Understand implication(s) of regulation(s) on system(s).
- Identify/re-evaluate notified bodies that can address needs.
- Manage timeline/deadline for submission, implementation, certification.
Memorable quotes by Bassil Akra:
“People are struggling with implementation considering all the situations at this moment in time. We have an additional burden, which is COVID-19.”
“Every device which has already certification according to the old legislation needs to re-get the certification to be able to keep market access.”
“We didn’t have the recipe on how to fulfill the requirements before getting the requirements published.”
“The number of notified bodies, we should not take as the most important part. The question is, how much capacity are those notified bodies having towards addressing the market needs?”
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: 2020 is flying by. And I don't have to tell any of you, it's been one of the strangest years in my life. I'm sure many of you can attest as well. Getting back to medical device topics, EU MDR it's upon us. I think we have a little bit of a gift in a weird way where the EU MDR implementation was delayed until May 2021. But as we're recording this podcast, that's literally just right around the corner and IVDR, the EU IVDR is not that far away either. And there's a lot of work that we still need to do as a medical device companies to make sure we're prepared. So good news is I have joining on this episode of the Global Medical Device Podcast, Bassil Akra with QUNIQUE group. Bassil has a kind of a unique distinction. He used to work for a notified body and I've heard him speak many times on EU MDR and IVDR. So he's definitely an expert. So you're going to want to listen to this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder from Greenlight Guru, Jon Speer. And folks 2020 is flying by we're almost to the end of the year. It's been one of the strangest years in my life. I'm sure many of you could probably attest the same thing, but we keep moving in the medical device industry and 2021 brings some new challenges, especially for those of you who are pursuing products in the European Union. And probably remember EU MDR, it goes live in May of 2021. So a lot of topics and challenges still facing our industry with respect to EU MDR and IVDR so who better to chat with us about that than Bassil Akra. Bassil is the co- owner and CEO of QUNIQUE. So Bassil, welcome to the Global Medical Device Podcast.
Bassil Akra: Thank you, Jon, for inviting me to be here with you today and discuss with you about this. A very hot topic that was very hot since many years, but it's getting hotter now. At a period where people are struggling with the implementation considering all the situation at this moment of time.
Jon Speer: Yeah, that side from the obvious with only being in about six months or so away, why is it so hot now?
Bassil Akra: It is so hot now because we have an additional burden, which is COVID-19, which is actually adding a burden to the whole implementation. It was hot before because people were talking about the increased requirements, the limited capacities of the main stakeholders who are the notified bodies. And on top to this, we got COVID- 19 which added an additional burden to the whole situation and leading to additional bottleneck and in a short period of time.
Jon Speer: All right. So hopefully today we can get some tips and pointers from you on what... Me as a medical device company, what I can be doing now, but overall I just want to get a sense too of the readiness. You mentioned some of the constraints on the system these days, COVID that certainly didn't help anything with respect to EU MDR readiness, but where do we stand today? As far as like the... How has the EU prepared for this? The notified bodies, manufacturers, the competent authorities, just give us a lay of the landscape as it stands today, from your perspective.
Bassil Akra: So it is actually not surprising guys, because we were talking about the readiness of the system since the publication of the regulation taking into consideration that, that's what was written in that regulation and the transition period, which was given to the different stakeholders. In 2012, we had more than 80 notified bodies. And when the MDR and IVDR were published, it was clear that all notified bodies available as of today, they need to recap, designate it for the new system, which means for the new regulation MDR and IVDR, to be able to serve the manufacturers when they want to get certified on those new legislation. Now saying that it should be clearly understood that every device which has already certification according to the old legislation, need to re- get certification, to be able to keep market access, which means that you need again to get certified by notified bodies. Nevertheless, we had more than 80 before, let's say, in 2012, we had the scandal which led to a reduction of notified bodies to approximately 55 notified bodies. And then now, if we looked at the numbers, we have just 17 notified bodies for the MDR. We got a promise to see one additional one coming soon. Nevertheless, by the end of the year, when Brexit going to happen, we're going to lose one again. So we have 17 MDR notified bodies and four IVDR notified bodies. Whereas also here, one cannot be lost when the Brexit is going to happen. So we are talking about one... Nearly one third of the previous available capacity under the new legislation. And we need to consider this factor. Now, people are talking about increased capacities at notified body side, which is true, but the increased capacity should be also dealing with increased requirement and deepness of reviews of notified bodies. So it is not really and answered for the system to say we have sufficient resources, because we miss also the transparency about the available capacity to be able to serve the markets.
Jon Speer: Yeah. There's a lot there to unpack. Where do you see is... the capacity is something that I think a lot of people speak about, the notified bodies situation, but it's a really good point that it's a little bit deeper than that. Where are some of the areas of the MDR and the IVDR that create new challenges? If you will. What are some of the parts of those regulations that are the most significant to address?
Bassil Akra: I think if we take both regulation, where we see the most impact is actually the fact that we got these regulations published and then the system started reporting guidance. So we didn't have the recipe on how to fulfill the requirements before getting the requirements published. So in the grace, or let's say in the transition period, the member States, as the legislators in Europe are explaining via guidance documents, how to apply these regulation accordingly. So this is like an uncertainty factor, which is now still up and running, whereas manufacturers and notified bodies want to implement the regulation. So this is the first important point, which is like you're asked to fulfill something that you are not sure how to fulfill it because you don't have the clear expectation. You have wording, which you have to apply, but it's unclear if you go in that way or in that way, which way would be the best way to fulfill the requirements. The second challenge is the fact that both regulations are putting expectations, which are not ready yet. Such as EUDAMED, which is towards transparency, better traceability and helping the system to ensure a single data, let's say, management system, enabling communication across the stakeholders. This system is not up and running yet. It will be implemented on a voluntary basis and model rate. But we still miss to have that system, which is an essential part of the regulation. The other part is also the increased requirements on the clinical evidence by setting higher clinical evaluation requirements in the MDR and higher performance evaluation requirements in the IVDR. And looking to those requirements they are applicable also for devices which were already since years on the market, which were certified and applied on the market for the various healthcare system in Europe and other jurisdictions, which are laying on the European system. And all those devices need to undergo a new certification according to the new legislations, which means they have to fulfill new expectations. It's not just applicable for new devices, it's applicable for all devices. This is adding an additional burden because manufacturers who have their devices on the market, they need to recheck if they have sufficient evidence to fulfill the expectation and who are going to tell you how much is sufficient. Now for the MDR, some guidance were created to help manufacturers and they are very helpful giving them a clear understanding. But even with those guidance, we are seeing different interpretation by the different stakeholders, including manufacturers, notified bodies and member states. And finally is the biggest challenge with those regulations is the expectation on having continuous reporting document such as the Periodic safety update report, which is increasing the expectations on resources, whereas this notified body system was continuously anyhow doing surveillance audits on manufacturer side and was able to identify post- market signal. But now they want to have also on top Postmarket Surveillance report, which are Periodic safety update reports, which are delivered for the devices without an end. So, which is like an expectation forever. There is no limitation on how often you should be doing that. Those are just requirements, which are written there with an open end and people need to plan their capacities. And everyone is getting now to the challenge that the market is not delivering the needed resources with the competency to fulfill the obligation of both regulations.
Jon Speer: Yeah. The post- market requirements on industry seem to be a lot more strenuous, if you will. You mentioned the Periodic safety update report. There's also the Postmarket Clinical Follow- up, there seems to be a lot more expectations on industry, but to your point, not always a lot of guidance on exactly how and when, and that sort of thing. You said something about in May 2021, all devices in the EU need to make that transition to the MDR. I know... I'm a little confused about this, so hopefully you can clarify the confusion. I have heard, I think, some folks state that if I still have a device that's CE marked under the MDD, that that buys me some time, if you will. That I have maybe a little bit more time to transition to MDR. Is that true or false?
Bassil Akra: It is true actually, but it's not buying you a lot of time, because you need to consider the fact that if you still have a valid certificate from May 2021 for MDR certified devices, the MDR is allowing you to keep placing devices on the market. Now you'll have to fulfill the prerequisite of the MDR with regard to that. And those include, for example, expectation on registering the devices, registering economic operators, according to the new regulation, as well as fulfilling the Postmarket Surveillance requirement and vigilance requirements of the MDR for MDD devices. Plus you are not allowed to introduce any significant change to the design or to the intended purpose of that device, that you are keeping placed on the market. So if you are intending to continuously improve your device, you will be limited and you will be pushed if you want to implement such a change, which is significant as a design or intended purpose to move to MDR. If not, you will not be able to implement it. So it is, let's say, giving you a bit of time, but you need to be very clever on how you use this time to address the remaining gap with regard to the MDR that you would need to address and keep in mind, 2021 periods, the grace period, will end in May 2024. This grace period is not giving you until 2024 to be ready. You need to be ready latest in 2023, by the middle of 2023, considering the fact that you need to apply to the notified bodies and they need to assess your fault and come to a conclusion on whether they certified the device or not before and after the grace period. And you need to consider also the validity of your certificate because 2024 is the end date. If your certificate is up and running and valid until then, and your notified body is still also accepted under those old legislation to be actually in compliance with old legislation. If this is not the case, then you may be facing challenges with regard to keep placing device on the market. So I would not play with this card to say it's an additional time. I think it is essential to work hard towards implementing the MDR requirement as early as possible. Considering the fact that waiting list as a notified body will be very long due to the limited number of notified bodies and the highest requests from industry to get certified under the new legislation.
Jon Speer: Now, I appreciate that clarification, Bassil. That was really important. And I think that things that I... When I've heard people talk about pursuing CE mark under MDD, they forget to mention things like the follow- up reporting and economic operators and all those sorts of things. So you have to replay. What I think I just heard you say is if you do that path, you still have to meet the intent of the EU MDR effective May 2021. So folks that you still might have some work to do, this is not a thing to buy you a little bit more time. There's still a lot of work to do. And here we are, and just a few months away from this going live. Folks, I want to remind you, I am talking with Bassil Akra. Bassil is the CEO and co- owner of QUNIQUE. QUNIQUE... you can find out more about them, go to quniquegroup. com and that's quniquegroup. com all one word, no spaces, no hyphens and that's all. Our guest, while we're taking a little bit of a break here, do you mind sharing with folks a little bit about QUNIQUE and some of the services that you help companies with?
Bassil Akra: Yeah. Jon, I'm happy to do so. So QUNIQUE is a consultancy organization and we help manufacturers on both MDR, IVDR implementation. We support from the scratch. So by developing quality management system, according to the new legislation, or by creating, let's say, doing a gap audit to identify your gaps and helping you also repairing by closing the gaps to the new legislations and by preparing technical documentation according to the new requirements. We provide also the various trainings, enabling manufacturers to understand the obligation according to the new system, and to fulfill also the expectations of notified bodies when they come in and audit you with regard to training the resources on the new requirement and giving them the relevant education to understand as the expectations. We do also on top to this leadership training and also help manufacturers, not just in Europe, but also for market access and other jurisdictions, including the U. S. by helping them on their submission to FDA and preparing them for getting inaudible audit and getting their systems certified according to the requirement in the U. S. So I think in general, you can see our services on our website, and if you have any questions, you can reach out to me or to one of our colleagues. The best way to contact us is info @ quniquegroup. com. and then we will get back to you within a short time and give you the guidance based on your request.
Jon Speer: And folks, I would highly encourage you to reach out to Bassil and the QUNIQUE team, if you have any questions at all about EU MDR, IVDR. I first crossed Bassil's path when he was previously working with a notified body. And it was very clear to me that if there is an expert and understanding the new MDR and IVDR, Bassil is one of those folks. So definitely somebody that you want on your team. So again, go out to their website quniquegroup. com, info @ quniquegroup. com, if you want more details and information about how they might help. So, all right, I'm want to transition a little bit Bassil as IVDR, obviously that's a little bit further away on it. And I fear that the industry companies that are in the IVD space, that they may be a little complacent and they may be thinking," Oh, I got all of this time. I got plenty of time." We had a customer the other day that was asking about, going down the EU IVDR path, and the notified bodies situation in that space is a little bit less yet still. I think I saw the other day there's only four notified bodies that are able to do IVDR tech files, is my memory correct on that?
Bassil Akra: Yeah. This is true. I mentioned this at the beginning of our discussion, actually four are not real four, we have one who's double counted which is actually kind of a risk mitigation due to the expected Brexit. So we have three notified bodies for the IVDR, and this is actually the number of notified bodies. We should not take as the most important part. The question is how much capacity are those notified bodies having towards addressing the market needs? And I think this is a big question mark, because we don't know how much market is there with regards to the IVD market and how much notified body resources would be necessary for the different scope to serve the markets.
Jon Speer: Yeah. And I think I had heard something and this is all, of course hearsay and that sort of thing. So I'm glad that you and I are having a chance to chat about this today, but I had heard something a while back that the EU IVDR will mean that something like tens of thousands of products that were not previously classified as IVDs or medical devices are not going to be considered as IVDs under the new IVDR. And that this is probably going to be very challenging for a lot of companies who have these particular products, because they may or may not have been designing, developing, manufacturing, their IVD products under any sort of quality system or design controls or risk and that sort of thing. So what are you seeing or what do you think that is going to happen with respect to the IVD side of the market?
Bassil Akra: So you have to see it in that way. Most of the IVDs in the past were based on self decorations. So where a manufacturer could say," I'm fulfilling the obligation without involving a third party," which is a notified body. And when I was at the notified body, all notified bodies, including industry tries to understand the impact of IVDR on the market. And when we look to this, we recognize that nearly 80 to 90% of the market at this moment doesn't need the notified body. Now under the IVDR, this is going to change to 80 to 90% of the market would need a notified body, which is a huge amount of actually and capacity expectation on the notified body side to ensure that the markets will be certified on time. Now, you mentioned in your introduction that the IVDR, most of the manufacturers, they say," we still have enough time." Reality is something else. Because if you look to the IVDR they don't have a much more time than MDR, but they had initially since the publication two more years. But it's not really two more years, it's actually the same time or less time by considering the fact that most of those manufacturers have no experience also with notified bodies. They need to get their system up and running according to the new legislation, and they need to ensure that they have technical documentation for the devices addressing risk related expectation, as mentioned in the IVDR and get to notified body who's willing to take them onboard. And who has the capacity to deliver the service, ensuring that those devices will be certified on firm, ensuring at the end market continuity. So I think the problem was the IVD is much bigger than anyone could assume. Most of the people are talking about MDR at this moment. And this is related to the fact that the MDR is coming first. But the IVDR is actually, in my view, the biggest troublemaker for the system. And it will be creating much more troubles because historically the notified bodies were not that big with regard to IVDR, because the market need was limited. And the requirement on notified bodies to have like much more devices although their duty with regard to IVD was also not that big. So now with regard to IVDR, they are required to deliver services if they have the designation for much bigger market. And if you want to deal with this in a short period of time, you need to consider the fact that the capacities and the experts are required for IVDR are not available, or they are available, but they are working for the manufacturers or they are working for the authorities or for the notified bodies. And you need to collect the relevant resources to be able to serve the market. And this is in a short period of time, not really something doable considering how big the IVD market is expected to be and is expected to be also under the responsibility of notified bodies.
Jon Speer: Yeah. I tend to agree with you. I think that the... Unfortunately I guess the focus has been on MDR because it's the nearest to us. But I've talked to quite a few IVD companies, they're just not ready and I've read... And I would encourage folks out there to do this as well, it takes a little bit of patience, but go read the MDR and the IVDR regulations. You can get these documents, they're pretty easily easy to find. We'll make sure we provide links to those as well with the texts that accompanies this podcast. But specifically on the IVDR side of things, there are a lot more expectations if you will. That for a lot of the companies that are now in this space are going to be brand new, they're going to be at systems that you're going to have to implement. And I think what's really interesting about the IVD side, from my perspective as well, is the newest version of ISO 14971: 2019 and the guidance document that accompanies that the ISO/ TR 24971: 2020. There's a lot of verbiage in those documents about IVD. In fact, the 24971 has an entire annex that is just dedicated specifically for IVD as far as all the expectations of criteria. So there's a lot more expectations for IVD companies with respect to these new regulation, and it's not trivial and it's not simple. So Bassil is right. Now's the time. If you're not starting to transition, you're probably behind right now. So, all right, that's all. Kind of working toward wrapping our conversation up a little bit today. What tips and pointers do you have for medical device companies and IVD companies? What should they be doing now? It seems to me obvious that first and foremost, they should be getting in contact with their notified bodies to find out what their plans are. But what other tips and pointers do you have for folks out there listening?
Bassil Akra: I think as a general, let's say, list of tips that I can share with IVD and medical device companies. The first tip is, first of all read the regulation, understand the implication of the regulation on your system. You mentioned, speak to your notified body. The question is whether you have notified bodies that can actually address your needs, because you need to re- evaluate your notified bodies and understand whether the notified body who was your partner for the last years will be able to serve you according to the new legislation, because some notified bodies may not apply for the regulations or may not receive the same disfiguration scope like they have on the old framework. And this is actually a limitation for the industry preparing for the new legislation. After reading, after selecting also, and discussing with notified bodies, you need also to manage a clear timeline for implementation considering the end date, which is actually in May 2024, considering that this end date is not your end date for submission, but your end date to be actually certified according to the new legislation. Don't plan to the last moment and make sure that your project planning is aligned with the notified bodies that you have selected to be your service provider at the end. And prepare yourself on time and don't take it really as an easy step, because there will be no delays in the implementation of the regulation. We got a clear message from the European commission that this delay, which happened for COVID-19 will not happen again. So nobody should be expecting a miracle. So be prepared, be ready on time, ensuring that your devices will be on the market long- term and will not lose the market access by date of application or later by end of grace periods.
Jon Speer: I think that's the key thing. I know as the original deadline of EU MDR was approaching in May of 2020, beginning of the year 2020, a lot of folks were like," Oh, they're going to delay, they're going to delay." And at that point in time, there was nothing to indicate that there was going to be any delay whatsoever. I don't mean this to sound wrong, but the COVID pandemic, frankly, it did a lot of folks in the industry who were not prepared to favor by delaying it to 2021. And folks, you shouldn't expect that this is going to be delayed any further. This is not an excuse to do the work and the diligence on your end to be prepared, because regardless the criteria that are defined within the EU MDR and IVD are, these are just good business practices, quite frankly. This is just you running a good business and making sure that your products are safe and effective. Part of the trigger for MDR and IVDR, unfortunately were some scandals are dents and device companies, maybe not doing the things that they should be to ensure the products that they're designing and developing and manufacturing are safe and effective. And so this is something that we should all take seriously as our responsibility as medical device professionals. Bassil, any last words for folks today, before we call it a wrap on this episode of the Global Medical Device Podcast?
Bassil Akra: I think I would like to close with a positive note. And I would like to say, you can make it, if you prepare accordingly. It's doable. It's not really a big burden. It's just a systematic evaluation and preparation would allow you to succeed towards the new legislation.
Jon Speer: That's awesome. Folks, again, I've been talking with Bassil Akra. Bassil is the CEO and co- owner at QUNIQUE. He and his team, they're experts in these needs from EU MDR, IVDR, as well as other markets and regulations that are impacting you and your product. So be sure to go check them out quniquegroup. com to learn more, contact them directly info @ quniquegroup. com via email and someone from their team will be in touch with you. And folks, again, I want to remind you here at Greenlight Guru, we're ready to help you as well. We've built the only medical device quality management system software on the market today, it's designed specifically to help you address these regulations in the EU or U.S. Or wherever else in the world that you're bringing products to market. So our purpose built platform has been designed with these regulations in mind, and it's been designed by actual medical device professionals. I've been in the industry for over 22 years. We have other medical device gurus on our team who have decades of experience as well. So go check it out, www. greenlight. guru, to learn more about the Greenlight Guru Medical Device Quality Management Systems Software Platform. Folks, as always thank you so much for being loyal listeners of the Global Medical Device Podcast. It's because of you that you continue to keep the Global Medical Device Podcast as the number one podcast in the medical device industry. So keep sharing and spreading the word with your friends and colleagues. And as always, 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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