Feeling gloom, doom, concern, and fear about the new European Union Medical Device Regulation (EU MDR)?
In this episode, Rebecca Sheridan shares some positive insights and updates regarding EU MDR and its In Vitro Diagnostic Regulation (IVDR). Rebecca is a former regulator herself, and now serves as Senior Director for Quality Assurance, Regulatory Affairs, and Clinical Affairs for the Advanced Wound Franchise of ConvaTec Limited.
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Some highlights of this episode include:
- EU MDR transition timeframe is very optimistic due to the complexity of today’s medical devices.
- The infrastructure needed to navigate through the regulations is still in progress. So, minimal guidance is a major challenge for the medical device industry.
- The medical device industry is at a crisis point where collaboration must occur to be able to support patients, public health, and healthcare institutions.
- An extension would pose additional challenges. The legal process takes time, decreases available resources, and delays implementation of changes.
- The capacity of notified bodies is expected to increase by the end of this year. Many devices need to go through process that were previously unregulated.
- Don’t panic, stay calm. Engage early on with notified body and provide technical documentation and clinical data regarding design controls.
- During the post-market phase, EU MDR/IVDR will impact companies’ quality management system (QMS) and infrastructure due to required reporting.
Free EU MDR Gap Analysis Tool
Nando (New Approach Notified and Designated Organisations) Information System
MedTech Europe Members
European Medical Device Regulation (MDR)
Medicines and Healthcare Products Regulatory Agency (MHRA)
Association of British Healthcare Industries
ConvaTec Group - Advanced Wound Care
MedTech True Quality Stories Podcast
Quotes by Rebecca Sheridan:
“The types of medical devices that we have on the market today, compared to 25 years ago, are significantly more complex in many areas.”
“To try and do those in such a short period of time with very little guidance is a really big challenge for our industry.”
“The infrastructure that we need to be able to navigate through the regulations is still being put in place.”
“An extension, it would be nice. However, to get an extension approved is a very significant legal process.”
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: You know, I'm actually encouraged by this episode of the Global Medical Device Podcast because it's about the EU MDR. And I would say, prior to having this conversation with Rebecca Sheridan, I had a little doom and gloom and fear and concern about the EU med device market. But the good news is, Rebecca is one of these folks that... She's in the know. She has her finger on the pulse, and she shares some positive insights and updates from her view of the world, with respect to EU MDR, IVDR.
Jon Speer: Hello and welcome to the Global Medical Device Podcast. This is your host, founder, and VP of Quality and Regulatory at Greenlight Guru, Jon Speer. Folks, have you heard the regulations, medical device regulations, in the EU have changed? It's confusing right now. I think people are looking for all sorts of answers and clarity. Hopefully, or maybe, optimistically anyway, maybe we'll get a few of those today with my conversation with Rebecca Sheridan. Rebecca is the Senior Director for Quality Assurance Regulatory Affairs, and Clinical Affairs for the Advanced Wound Franchise of ConvaTec limited. Rebecca, welcome.
Rebecca Sheridan: Thank you, Jon. A pleasure to be here.
Jon Speer: So I put the pressure on you. You're gonna give us some answers [chuckle] today. I hope that's okay.
Rebecca Sheridan: I'll do my very best. There is some ambiguity but there is definitely things that we can be doing to help ourselves. So let's hope we can see some of those out today.
Jon Speer: Okay. That sounds good. And folks, just to give you a little bit of background. I've known Rebecca for a bit. At least for a few years, she used to be with one of our customers years ago. And even before that, we learned that we were doing some work at the same time for one of the big orthopedic companies, many years ago. She was in the EU, and I was in the US, but I think we might have been approving the same documents [chuckle] during that up class effort. That was a good time, right?
Rebecca Sheridan: Absolutely, yeah. Again, another great time when an opportunity to learn about the regulations, which have driven us to where we are today with the MDR.
Jon Speer: Absolutely. And the other things you should know about Rebecca is she also has quite a bit of experience as a regulator. She used to be with MHRA. So to sum up, it's not doing the justice for sure, but to sum up who we're talking to today on the Global Medical Device Podcast, Rebecca is a former regulator. She's worked for very large companies. She's worked for startups. So she has a pretty good perspective. And her finger is definitely on the pulse of what's going on in the EU MDR and the UK, and all that noise that we're dealing with today. So, I guess, Rebecca, just to get things started a little bit, we're about two years into the transition period, what's happening? What's going on? How is this evolving? Just your view of the world with respect to EU MDR. What's going on?
Rebecca Sheridan: So I joined the medical device industry in the transition period of the directives, as we know them today. And the transition period, really, we had for each directive, was five years each, of which there was a two-year period for the member states and the notified bodies to get their start together. And then a three-year transition for industry. For the MDR, there was an incredibly optimistic approach of a three-year transition period for all of us. Now, of course, the types of medical devices that we have on the market today, compared to 25 years ago, are significantly more complex in many areas. There's connected devices, which we didn't have before. The level of implantable devices that we have previously, we didn't have those. Deep brain stimulation was something we weren't even considering back in the early mid '90s. So there's a lot more substance to the types of devices being placed on the market today. And to try and do those in such a short period of time with very little guidance, is a really big challenge, obviously, for our industry for notified bodies, but also for member states.
Rebecca Sheridan: And the infrastructure that we need to be able to navigate through the regulations is still being put in place. So we are in an environment where there's a lot of stress within every single part of the infrastructure, not just industry. And I think the next year, the level of collaboration that we all need to have to work together to get us to where we need to be, is going to have to be the very best that we can all make it. So we're at a crisis point, I think, in being able to achieve what we need to do as an industry to support our patients and our healthcare institutions, continue to support public health. So it's at a crisis situation.
Jon Speer: And something's gonna have to give another. Some folks that are... I've heard that they think that there will actually be an extension that's gonna be provided, or something is going to change, but at the same time, that doesn't seem very pragmatic, considering all that has to go into... Or all that went into all the member states, and all of the resources that went into actually defining the EU MDR. To develop some sort of extension from a time frame standpoint, that just doesn't seem very pragmatic, considering all the government bodies and other entities that are involved. What do you think about that?
Rebecca Sheridan: An extension, it would be nice. That would be really nice. However, actually, to get an extension approved is a very significant legal process. And the ability of the European Parliament, and the commission to execute on that, is very challenging and very time consuming. So... And I'm not sure it would gain us anything as an overall industry. And in that industry, I'm including all competent authorities and notified bodies and member states, because they would be distracted having to put that through and to try and make that extension and not focusing on actually what we need to execute to the MDR. Have to get all the common specifications and all that, the infrastructure, a new demanding place. So it would dilute the resources available to help us out and get what we need. And then, the extension, we would be no closer to achieving an... The deadline of an extension.
Jon Speer: Yeah, it's a really good way of looking at it. So folks, I mean, there's other challenges that would make an extension not very useful, frankly. I think the other thing you said, we're approaching crisis mode or maybe we're in crisis mode. I think part of what's driving that right now is there's not a lot of notified bodies that are available, right?
Rebecca Sheridan: That's absolutely right. We have BSI UK, and they are designated as a notified body under the MDR. And of course, we'd have the situation like being confounded by Brexit. And the work that the UK notified bodies have had to do in order to be prepared for Brexit, which of course haven't yet happened, had been very disruptive to our industry, and also diluted the resources available to support the transition to the MDR. Now, ConvaTec is a client of BSI, and we were notified yesterday that as of the 3rd of June, they will be accepting the submission to transition to the MDR through BSI UK, so...
Jon Speer: Wow. That's hot news.
Rebecca Sheridan: It's something that I was hoping might come out of the situation with the delay to Brexit because we do need to get moving. And so, I see that our notified bodies, when they are able, are being pragmatic and trying to help open up the gates for us to start to engage with the MDR. And the other news we hear is that a second notified body will be designated next week, or they have been designated but it hasn't yet been published on Nando.
Jon Speer: Alright. So we'll have a 100% increase in the number of notified bodies in about a week.
Rebecca Sheridan: Absolutely. [laughter]
Jon Speer: Going from one to two. But two notified bodies isn't gonna cut it, right? So do you have any insights into... And I know a lot of other notified bodies are going through the process to get the formal accreditation permissions, whatever the right label is. But do you have any insights on to how many others are going through that process right now? And any insights as to when we might expect others to go through that? I know that this is a crystal ball sort of question for you.
Rebecca Sheridan: There's the absolute details, I do keep an eye on Nando and look at how many audits have been done by the member states and the commission. But for the feedback that I've heard this week, is that the capacity will have increased significantly by the end of this year. So we may have more... Up to maybe more than 20 notified bodies designated by the end of the year. Now, the two of the top five notified bodies, the two primary notified bodies will be designated within a very short period of time, and so that capacity is for their existing clients will be there. However, the one thing that isn't clear to me is the capacity really needed under the MDR and the IVDR that those devices which have not been classified as Class 2A, 2B and 3, previously. So software, as a standalone medical device has been Class 1. But now, under the MDR, and depending upon the consequence to the patient of using that, or the healthcare professional, and decision-making, they could be up to Class 3. And so, we don't really know just how many new companies are going to be to have to go through the notified bodies. The capacity for IVDR just needs to significantly increase. Of course, we've got devices about medical intent. So there's many more devices that are gonna go through the notified body capacity that we we're still not fully aware of. We're hopeful.
Jon Speer: I'd like to explore that a little bit, 'cause I think this is something that is probably one of the more significant changes, at least from my lens of the EU MDR and IVDR. The software was a really good example. A lot of software products in the old construct may have been Class 1, type of products, and now that might be shifting for a lot of software as a med device products. And then, the other, the IVDR, if I'm understanding this correctly, there were a lot of things that are now in scope of the new EU IVDR, things like RUO, LDTs, things of that nature, that previously were unregulated, so...
Rebecca Sheridan: Yeah.
Jon Speer: Do you have any concept or idea of the magnitude? I mean, I gotta imagine it's still probably pretty unknown.
Rebecca Sheridan: So, certainly IVD is not an area which I've had a significant amount of experience in the past. What's really exciting for me at ConvaTec is this is a space we're getting into, and so I can speak from my perspective of what in our development program is that the product in developments on the MDD would be self-certification but under the IVDR is now a class B, so it's now regulated through a notified body. So there are going to be many companies who fell into the self-certification who now have to start to engage with a notified body and I think it's a chain, so if we take 100 companies, IVD companies if it was 20 who had to engage with the notified body previously, it will now be 80.
Jon Speer: That's pretty dramatic increase.
Rebecca Sheridan: Yeah.
Jon Speer: Yeah, yeah. And I know a few years ago there was similar conversations happening here in the US, in fact I think it was a guidance or draft guidance or something of that nature and this was prior to the current administration but there was a hint that LDTs might become regulated as med devices here in the United States as well and then whenever President Trump was elected, I think the FDA kind of backed out off and then so that would be a decision that the new administration would determine and when that happened the US backed off on LDTs being regulated so do you have any sense of what was the motivation or the driving force behind pulling LDTs under the IVDR?
Rebecca Sheridan: No, I wasn't involved in the development of the IVDR, I was involved in the early stage discussions with industry and the commission through the trade associations on the content of MDR but not the IVDR.
Jon Speer: Alright, so as it stands today and folks, the IVDR has a little bit longer period of time, I'm not suggesting that you sit back and wait because especially for those of you who maybe you weren't previously regulated under the IVD directives and then now you're in scope of the IVD regulations, now is the time to start to figure out who, what, when, where and how this is going to impact you and your IVD products so don't think that you have a lot of time available because that time is going very, very quickly and my best advice to you is to engage with notified bodies as Rebecca shared BSI UK is good to go. There's another that's coming here in the next week or so and it sounds like here in the next few months there will be quite a few others but do start engaging those conversations with notified bodies to figure out your plan and your path to get your products to market.
Jon Speer: Folks, I wanna remind you I'm talking with Rebecca Sheridan. Rebecca is the Senior Director for Quality Assurance Regulatory Affairs, a Clinical Affairs for the Advanced Wound Franchise of ConvaTec Limited and I wanna also take a moment to remind you, did you know that Greenlight Guru has a brand new podcast? That's right, check out MedTech True Quality Stories wherever you're listening to this podcast, you should be able to find MedTech True Quality Stories, it's just an exciting opportunity that I get to have every so often to talk to folks who are leading medical device companies, CEOs and founders and listening to some of the challenges that they're faced with and how they're overcoming those challenges with true quality approaches so be sure to go check that out as well. Alright, so Rebecca, what advice do you have for companies who are trying to figure out what to do with Europe? I've heard some extreme situations where some folks are saying that they're gonna be exiting the European market, especially for products that maybe they've had in the EU for a number of years, that maybe they don't have a robust up-to-date current technical file and CER and things of that nature, what pragmatic tips do you have for folks that are trying to figure out what to do about Europe?
Rebecca Sheridan: Okay, so the European system is still a fantastic system even with the changes that are being made and really... This is gonna sound very quite simplistic, but the really significant differences between the medical device directive and the medical device regulation, in my head, can be really distilled down to two discreet areas. So one area is regarding the manufacturing controlled manufacturing information, the process of MEA which generally didn't use to sit inside your technical file or your design dossier, that would be something that you would move forward with a design examinations certificate for a class 3 on the same approach for your technical file but now as part of the MDR this needs to be part of that technical documentation that you see module device too. So that element is different. The other side of it is regarding clinical data, there's something called a summary of safety and clinical performance that we now need to make publicly available through MDR on EUDAMED. And for class 2A to B and class 3 devices they need to be approved by the notified body before you first make them publicly available. And if you look at the last revision of the medical device directive, the requirement to do proactive post-market survey and keep your clinical evaluation updated in the post-market phase was captured on the Annex 10, section 1.1C. Now, under the MDR that requirement is still there.
Rebecca Sheridan: And we talk about post-market surveillance plans so we need post-market surveillance plans where needed. You'll have to have post-market clinical follow-up plans as well, or a justification where you don't need them, and then they go up and to be assessed in product safety update reports, class 2A to B and into three, and the outputs of those tell you when you review critical performance. So those are the elements that is leading about summary of safety and clinical performance which is publicly available information on your devices through EUDAMED that say, "This is a safe medical device," this is what you as a consumer, as a healthcare professional can understand about the safety profile of the device.
Rebecca Sheridan: Those are really the two significant differences as I see them and from the MDDs into the MVR. And one of the biggest concerns that I hear from people is well, I've got a device that I designed and developed maybe 10 or 15 years ago, and the technical documentation is commensurate with the time it was designed and developed and people, "Well, do I have to re-do all the design work?" No, no, no let's take a step back let's think about it sensibly because it was actually okay when it was designed and developed 10, 15, 20, 25 years ago. And you actually have a huge amount of design verification data in your manufacturing batch records, etcetera, because you do in-process quality inspection, and monitoring of the quality of your devices and that's absolutely super design verification data that you can use and build into irrational to say actually, I do have a device that under today's requirements fulfills those design control, the design control data that you would need to show you've got a safe and effective medical device.
Rebecca Sheridan: There are ways around what we perceive if we read the regulation and take it as it's read, "Oh my goodness, my device or my devices, don't fulfill these requirements." We need to take a step back and think about our product and think about, a replacing products on the market today. They're not harming people. And actually, it's also how novel the device is as well and how innovative the device. The purpose of the MDR is to make sure that public safety is being prioritized and unsafe medical devices are not being placed on the market, so we need to be, I suppose, calm in our mind and not panic, and say, "What pragmatic solutions are there so that we can maintain our products on the market?" The MDR is not to prevent people from coming into the EU market, or to have existing products removed from the market if they are safe and effective.
Rebecca Sheridan: So engage early with a notified body understand their perspective. Talk to people in the network, one of the... Particularly if you're an SME, it can be very difficult to get access to good quality and reasonably priced advice and guidance. And your trade associations in the different countries across the EU are absolutely fantastic resources and people think, "Oh, but the trade association must be very expensive to join." If I use the UK as an example for SMEs, there's a very good package. It used to be... I don't know exactly that, but let's say no more than 2 1/2 thousand pounds a year slap rate for SMEs and startups where you can access a huge amount of experience to help you with the MDR IVDR and understanding what your options are, and also can help connect you to some really knowledgeable people about how to navigate this process. So go reach out and network and look for those opportunities, that fit the size of your company 'cause they are there, and people are there and they want to help.
Jon Speer: So Rebecca, do you have maybe an example or two of a trade association for folks that might be looking, the words might be helpful? And folks, I did the conversion 2500 British pounds is roughly 3200 US dollars. So it's very affordable, especially if it gives you some guidance direction in a path. But do you have any trade associations that are worth mentioning or would you rather not?
Rebecca Sheridan: Well obviously the Association of British Healthcare Industries in the UK is an excellent UK-based medical device company. You have Assobiomedica in Italy, who are very active trade association, you have SNITEM in France and there are others which are available, you can actually on the commission website, and through also MedTech Europe's website you can find a list of all the different trade associations in the different member states as well, so the information is actually very easy to find.
Jon Speer: Alright, well, we'll find... Folks, I will provide a couple of those links for you to do a little bit of homework and a little bit of research on that. So, Rebecca this is really insightful and I would have to admit before we started chatting today that I was of the impression, that you might be some doom and gloom, but you've identified some silver linings that this is achievable, and it's doable. The other thing that I picked up from what you shared a few moments ago is, for those folks that may be saying, "Oh, all these things in the EU MDR, especially clinical evaluation reports, and so on, and the post-market surveillance, this is dramatically new and different," but that's really not accurate. A lot of these things, the ground work for these were laid prior to the EU MDR being formalized a couple of years ago. So just because you as a company maybe didn't keep things up to date doesn't mean that those provisions weren't there. I guess, to kind of wrap things up, do you see that this transition to EU MDR and IVDR that this will have a dramatic impact on, say, a company's quality management system or their business infrastructure?
Rebecca Sheridan: I would say, in the post-market phase, yes. There's a lot more reporting, a lot more summarizing of clinical data, and interacting in the post-market phase with EUDAMED. The thing that is going to, for class-three devices, which is a significant difference, and our mindset will have to change is that when you are planning your pipeline and your submissions to your notify body. Particularly if you're thinking about going through a fast-track route which some notified body's offer, you would submit all your technical documentation, which includes your clinical evaluation report a few days before the the planned review. Now, there's a requirements that the clinical data is reviewed before to ensure it is fulfilling the requirements of the MDR, before they will agree for someone to come on site or to start that dedicated review or the review of that design dossier. So in talking with our notified body, it's about a three-month period.
Rebecca Sheridan: So, you would submit your clinical evaluation report three months ahead of when you would plan to have your dedicated or your technical review of the rest of the documentation. So, that's a change to how we do our planning. And as I have been thinking about this, "Well, does that mean we stop and then we pick it up again?" But of course, with the fact that we're now gonna have to include all that the PFMEAs, and the manufacturing and process control, that would normally take an additional three months. So actually for what we need to submit to have a successful conformity assessment that will not cause a delay, but that is something we will have to change, we will have to build into our infrastructure as we're thinking about class three devices. How that will affect our class 2B and class 2A devices, once you have the family of devices, a group of devices on your MDR certificate and self-certification, and how your technical files that's in your sampling plan, how it will affect that, we don't know yet. But I see a definite change to the infrastructure in the post-market and the reporting that needs to be done through PSURs and the summary of safety and clinical performance.
Jon Speer: Alright, well is there a source that you can guide listeners to that, that maybe give them a little bit more insights into those changes that they should be planning for, and incorporating into their systems, is there a good source of truth that you would recommend?
Rebecca Sheridan: The commission website has some really good information and tells you the program of work. So, that's a good source of truth. Qserve who's a medical device consultancy based in the Netherlands, they have blogs that they're publishing and keeping up-to-date with what is going on. So that's a place where I go to to find out, to keep my finger on the pulse of what's going on. And also interact with groups on LinkedIn as well. So there's some good medical device Forums on LinkedIn, which people are sharing information as it's published. So those are good areas where you can go, and they're free of charge as well.
Jon Speer: Alright, terrific. Rebecca, this has been really insightful. And like I said, I'm actually more encouraged about the EU and transition to the MDR and IVDR after we've chatted. So thank you for that. Folks, Rebecca Sheridan, she's a wealth of knowledge. If you ever have a chance to chat with her, or to connect with her, I would encourage you to do so. She's definitely one of those people that always has her finger on the pulse of not only what's happening in the EU and in the UK with respect to medical device regulations, but she's paying attention to what's happening globally as well. So connect with her, learn more about her experiences, and she can point you in a lot of different directions to help you stay on the right path when it comes to your medical devices. So Rebecca, thank you so much for taking some time to chat with me today.
Rebecca Sheridan: Thank you. It's been an absolute pleasure, as always, Jon.
Jon Speer: And folks. Quality Management System, yeah, that's what we do here at Greenlight Guru. We have the only EQMS software platform designed specifically for the medical device industry by actual medical device professionals. When it comes to things like ISO 13485, FDA, EU MDR, we've got you covered. So be sure to go check out what we're doing at www.greenlight.guru and request more information and get on the phone and chat with some of our experts and our account executives to really share with you what it is that we're doing and how this is going to help you stay prepared with all of the tsunami of regulatory changes that will be constant in our industry for the foreseeable future. So be sure to check that out. As always, this is your host, founder and VP of Quality and Regulatory at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device podcast.
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