Assessing the Global Regulatory Landscape

With medical device regulations tightening around the world, especially in Europe, it's important to assess the changes unfolding across the global regulatory landscape in order to fully understand how it impacts your business and product.

In this episode of the Global Medical Device Podcast Jon Speer talks to Adnan Ashfaq, founder of Simplimedica, about the changing global regulatory landscape, offering many valuable nuggets of wisdom to help medical device professionals navigate those changes accordingly.

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Some highlights of this episode include:

• Adnan describes the transition to EU MDR as an interesting but rocky and rolling landscape. Some companies acted quickly, but others are still waiting to take action and are not convinced of things that they have to do.
• Pieces are still being put in place. Medical device and in vitro diagnostic regulations have their own massive challenges. Also, there’s challenges with EUDAMED, designated notified bodies, and SaMD.
• EU MDR was supposed to go into effect in May 2020, but due to COVID-19 and other reasons, it was pushed off for a year. Guidance drafts were available in 2014-2015, but only a few hundred companies have made that full transition.
• According to a survey conducted by RWS, 53% of organizations are impacted by both EU MDR and IVDR, yet only 4% of those organizations admit that the regulations are a top priority.
• Companies with a medical device should proceed to effectively implement EU MDR or it may cost them their business. Also, refer to the definition of medical device that includes monitoring, prediction, and prognosis.
• Adnan encourages companies to not underestimate the cost of quality and regulatory. Build it in and know your market. With labeling and packaging, don’t forget about Brexit and associated symbols/marks.
• Regulations happened to catch up with technological advancements and public safety to become more transparent because patients were traumatized or died due to failure of efficacy in medical devices not being tested appropriately.

Links:

Adnan Ashfaq on LinkedIn

Welcome to Simplimedica - Simplifying Device Regulation

Guidance - MDCG endorsed documents and other guidance - Public Health - European Commission

European Union Medical Device Regulation (EU MDR)

European Union In Vitro Diagnostic Regulation (EU IVDR)

RWS - Almost three-quarters of medical device companies ready to meet the European Union’s MDR and IVDR regulations

EUDAMED

FDA - Software as a Medical Device (SaMD)

Brexit

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru

Memorable quotes from Adnan Ashfaq: 

“They’ve really had to rethink their entire commercial strategy - whether they want to keep their devices within the European market, whether it’s financially feasible for them to continue doing that, or whether they want to rethink their entire strategy and think globally where their best markets are.”

“I think it really boils down to what is priority, and a lot of businesses don’t actually realize to keep themselves in business that they need to see this as a high priority.”

“Regulations are mandatory, they are not optional.”

“Don’t underestimate the cost of quality and regulatory and very often, that is done. You have to build it in. You have to know your market.”

Transcription:

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

Jon Speer: On this episode of the Global Medical Device Podcast, I talk with Adnan Ashfaq. Adnan is the founder of Simplimedica. That's a great resource to really try to help simplify medical device regulations, and your knowledge and understanding of those. And you can learn more by visiting his website, simplymedica.com S- I- M- P- L- I- M- E- D- I- C- A.com. But during this episode, we talk about assessing the global regulatory landscape, and what these changes mean for you. And specifically, we talk a lot about EU MDD transition to MDR, and a little bit about the upcoming transition from IVDD to IVDR. So, lots of good nuggets of information in this episode, and I hope you enjoy it. Hello, and welcome to the Global Medical Device Podcast. This is your host and founder at Greenlight Guru, Jon Speer. Joining me today is Adnan Ashfaq. Adnan is the founder of Simplimedica. Adnan, welcome to the Global Medical Device podcast.

Adnan Ashfaq: Thank you very much, and lovely to be here with you.

Jon Speer: Absolutely. And you're calling from lovely Scotland if I'm correct, right?

Adnan Ashfaq: Unfortunately not at the moment. So I'm kind of relocated to Leeds, England at the moment, but I have my registered office still in Edinburgh and Scotland, but currently in Leeds, England.

Jon Speer: Okay. But UK, right?

Adnan Ashfaq: The lovely north of England, yes.

Jon Speer: Well, I thought today we could talk a little bit about... I guess the working title to speak... is assessing the global regulatory landscape and what those changes mean. But specifically, I thought we could dive into the EU MDR and that sort of thing. And yeah, maybe that's a really a great place to start. Obviously, you work a lot with medical device, and I think pharmaceutical companies, if memory serves... of all shapes and sizes. On the med device side, I'm sure you've been in the trenches trying to help companies figure out this transition from the EU MDD to the MDR. I guess, give us a lay of the land. What are you seeing these days?

Adnan Ashfaq: Yeah, it's been an interesting rocky, rolling, three to four years since the regulations actually came out, and some companies were very quick to act upon it. In fact, some of them were well advanced, even in the draft stage, they were doing things. But the majority of the companies are still sitting there waiting to smell the coffee, so to speak. They're still not fully convinced that this is something that they have to do. There's been a big shake- up in the industry. Of course, we've had the pandemic since last year, and that's really kind of scuppered things for a lot of companies. And they've really had to rethink their entire commercial strategy, whether they want to keep their devices within the European market, whether it's financially feasible for them to continue doing that, or whether they want to rethink their entire strategy and think globally where their best markets are. And so there's been a whole shake- up in the industry, and lots of things are still being put in place. The whole kind of jigsaw puzzles... not in place. EUDAMED still kind of half baked, and we still have lots of challenges with IVDR, massive challenges with IVDR. I kind of see them as two separate challenges. Well, we talk about the European regulations, but the medical device regulations and the in vitro diagnostic regulations both have their own challenges, because we've been a with the MDR with the cutoff point, which was meant to be last year, the date of application, and that got extended because of COVID to'26 May this year. The medical device companies that were applying for the MDR... a bit of a head start. Not only that, but also many more designated bodies for MDR, I think 26 designated or 23 notified bodies under the MDR, and only six under the IVDR. So huge, huge challenges.

Jon Speer: Yeah. I think you hit on a couple of points there that we can talk a lot about a little bit further. I mean, first and foremost, we all know MDR was supposed to go into effect in May of 2020. For obvious reasons that was pushed off for a year. So it went into effect May 2021. But we've known about the MDR regulations, I think those were first released to the world... what was it, 2017? I think if I recall? Something like that?

Adnan Ashfaq: Twenty-seventeen, but there was drafts, I think, thinking about almost as early as 2014 or 2015, couple years before. And they kept knocking them around, back and forward, and some companies managed to get hold of the draft, and they were very keen on moving things.

Jon Speer: Yeah, exactly. But to this point though, none of this really should have been a surprise. As you and I are talking today, I think only a few hundred companies have actually made that full transition, and that's surprising to me.

Adnan Ashfaq: Absolutely. It was a recent survey which was done by some organization, RWS, and I did manage to place some statistics, which are quite interesting. Fifty- three percent of organizations are impacted by both MDR and IVDR, and only 44% of those organizations admit that the regulations are their top priority. So I think it really goes down to what is priority, and a lot of businesses don't actually realize, to keep themselves in business that they need to see this as a high priority. And it usually comes back down to senior management not seeing this, because all they're interested in is sales. And it's kind of, unfortunately, a bit of a backward mentality. They're not realizing that quality has to be up there, and regulations are mandatory. They're not optional.

Jon Speer: Right. And yeah, I think in early days prior to... Let's go from a period of about 2017, probably even leading up to May of 2020, a legitimate argument that was often presented is there's not enough resources, there's not enough notified bodies, et cetera. So for the longest period of time, I know I was like," When is that going to change?" Because I think early days there were only a handful of entities that were credited to be able to do this. I'm like," That's not enough to meet the demand." But to your point, twenty- some organizations for MDR today, I mean, okay, is that enough to serve the world demand? That's maybe debatable, but nonetheless they're there. And the fact that only a few hundred or so companies have actually gone through and followed through with that process. That's a little interesting to me.

Adnan Ashfaq: Yeah, right.

Jon Speer: But I think you're right. I think if you don't prioritize this, then you're going to ignore it. And I think ignoring it, it's not a really good business strategy.

Adnan Ashfaq: No, it's not. Unfortunately, I remember watching my LinkedIn profile, and people posting how many notified bodies had actually been designated under the MDR. And I can't remember if it was towards Christmas last year, or the year before... I think it must have been the year before, where we had a handful of notified bodies, cause at that point 26 May, 2020 was a deadline. So everybody was panicking at that point, and nobody knew that COVID was going to happen, and no one knew that there was going to be an extension on the date application for another year. So at that point there was a huge panic, and people were just watching how many notified bodies we were gaining by Christmas that year.

Jon Speer: Right.

Adnan Ashfaq: And I think it was 2019, and there were not many, it literally was a handful. So I think what happened was, there was a huge burst off notified bodies that came into place as designated, since that December up until present date. So those 23, if you think about it since the advent of the MDRs, that really is a really small number, even still within that space of time. But it's progress, but very, very slow progress.

Jon Speer: Yeah.

Adnan Ashfaq: Of course they've got backlog as well, working on other things.

Jon Speer: Yeah, but I don't think that's the constraint today. Do you?

Adnan Ashfaq: I don't think it's a constraint, but I still hear lots of excuses from companies using that as an excuse, and then using COVID as an excuse. And they're just really drawing it out until it gets to the point where it really, really becomes fatal for the business. And that might be the fact that a notified body actually removes the CE marking, or they get a warning letter, or they turn up the doorstep with an unannounced audit. Or something like that happens, which has to be gravely detrimental to the business.

Jon Speer: Yeah, so I guess let's help explain, or help me understand. There's a few hundred companies that have made that full transition, and good for them. I'm glad they did it.

Adnan Ashfaq: Yeah.

Jon Speer: But what about the tens of thousands of companies that have not. What is their state of things right now? Are they just kind of rolling the dice, hoping that they can continue on as business as normal? Did they file some sort of an extension? How are these tens of thousands of companies continuing they haven't made that transition? What are you observing?

Adnan Ashfaq: I think that's the good question upon the subject, because I think that I'm seeing a number of things there. As I said, the skew scale- back, where the product ranges have been reviewed, and rationalizing their skews. And dropping some of the products from the range saying," This is not financially viable, let's just drop these ones. And then let's only just do what's the high risk, what we really have to do, and get them through the high sales volumes." So there's a big question around that. And then there's also a question mark, whether there's a big change between the directors and the regulations between the definition of what's gone from... let's say software for example. The Rule 11, which was the new rule that came in, which really caused a big shake- up for a lot of device companies, software as a medical device. And they're really questioning," Suddenly we've been self- declared, we've not had to have notified body. We've not to have any audits and suddenly we have to do all of this." So that's really made a big change in their business strategy. And some of them, again, they've had to review whether they've actually wanted to continue the business of medical devices or not. But it's interesting when you go back to the definition of what is a medical device, and I've seen here, a lot of companies go back to the actual definition and review to see whether they really actually define themselves as a medical device anymore.

Jon Speer: Interesting, really interesting. Folks, I would remind you, I'm talking with Adnan Ashfaq. Adnan is the founder of Simplimedica. You can learn more about Simplimedica by visiting their website, S- I- M- P- L- I- M- E- D- I- C- A.com. And Adnan, while we're taking this break, share with folks, what is it that you do? How do you help them?

Adnan Ashfaq: Yeah, so basically, a lot of my clients are startup companies that have basically no idea about regulations. They've got a concept in their head, and they want to launch into the market. And even sometimes that market can be unclear, whether it is the European market or whether it's the US, which are the two biggest global markets in the world. And it's basically outlining what that regulatory pathway looks like, how long it's going to take them to get to market, what it needs, what the costs are going to be like. And there's handholding them throughout the entire process till they get their CE marketing, or whether it's FD submissions that they need to do, or any other global markets. So it's making sure that they've got everything in place, and that the medical device industry is understood. And we try to make the business name, Simplimedica, explains that we're trying to simplify the medical device industry where it's riddled, absolutely riddled, with regulations.

Jon Speer: Absolutely. And folks, I would encourage you to go to the Simplimedica website again, it's S- I- M- P- L- I- M- E- D- I- C- A.com. Lots of information about how Adnan and his team can help you. And there's a pretty clear button that says," If you want to talk to Adnan and his team, just click the button and schedule a time." It's really that simple. And so I encourage folks to do that. While we're taking the break, I want to also remind you about Greenlight Guru. Greenlight Guru has the only medical device success platform on the market today, designed specifically and exclusively for medical device companies by actual medical device professionals. So within the software platform, there are workflows to help you manage documents and records, design control, risk management, and all of your postmarket quality events. Things like CAPAs, complaints and things of that nature. And it's all on a single platform, a single source of truth. So if you'd like to learn more about the Greenlight Guru medical device success platform, then please go visit www.greenlight.guru. And we'd be happy to have a conversation with you and understand what your needs and requirements are, and see if we have products and solutions that might be able to help. All right. So far we've talked a lot, sort of the lay of the land, some of the issues and the challenges. I guess in the next few minutes that we have today, let's talk about the proactive, positive... I guess not so much proactive, but what are things that companies should be doing? Let's imagine that someone listening is in that state of where they haven't made that transition from MDD to MDR. Maybe they've been eliminating some of the skews, or the products in the EU market, for whatever reason. What are some next steps that these companies should and could be taking in order to effectively implement MDR?

Adnan Ashfaq: Yeah. So, I would say, first of all, if you've got a medical device, then you need to proceed forward with the regulations. So there's no question about it, but if you're still doubtful, you need to look at the definition of the medical device. And I think it's quite interesting when I looked at the medical device definition, and compared it between the FDA and the European regulations, the three terms, which I didn't quite see in the FDA, which are monitoring, prediction, and prognosis. And I thought that was quite interesting. And maybe the FDA are reviewing their definition of a medical device, because if you think back from'93, from the directive of the European directives, these terms were not so obvious. They may not even existed. I'm not sure if they were, but that's probably because the advent of technology has moved on so further forward in the last 25, 26, 27 years or whatever. Amassed till 27 years, has moved on so significantly that you've got artificial intelligence, and machine learning, and all sorts of things going on with nanotechnology. And the European Medical Device Regulations outlines all of that because it's supposed to be bringing technology and regulations up to date. So there are solutions within the regulations, where I have to admit when I first looked at the regulations, and most companies do it... it just looks like 150 to 200 pages worth of bumph, right? Riddled with lots of more complications. So while it was supposed to made things easier from a 60 page document in the directive, to 150 page document in the regulation, it's made things more difficult. There's much more terminologies that people have to get familiar with. But I think the good thing is that there are... European Commission have issued out these MDCG documents, the Medical Device Commission Group, and those documents are very, very useful as guidance documents. So I would say to those companies," Get on with the regulations, don't think that there's not any guidance documents out there. Check out the European Commission website. There's a ton of Medical Device Commission guidance documents, and they're still issuing them. There's still a lot of documents that are being issued. And when you get stuck, try not to do things alone. Try and really speak to people that know the business. And that's what consultants like ourselves, and Greenlight Guru, and other people are out there for, is to help you through that pathway. That's important. The other thing also is, don't underestimate the cost of quality in inaudible, and very often that's done. You have to build it in, and you have to know your market. You have to know which market, if it is the European market. And also remember that the UK market has changed also, because of Brexit. So there's the UKCA Mark, and the UKNI Mark for Northern Ireland, which has further complicated things, as if it was already complicated and interesting. It's just become a bit more interesting and more complicated. So within the European Union, you've got the CE Mark to think about, but then within UK and Northern Ireland, you've got these other symbols to think about. So when you look at label in packaging, you have to make sure that your label in packaging has enough space on it to accommodate the potentiality of all these symbols. So there are definitely challenges. I'm not saying they are not, but if you don't proceed and get on with it, unfortunately it could cost you your business.

Jon Speer: I think that's really important for folks. As you mentioned, the EU, and then the US are easily the two largest markets for med device technology in the world. And yeah, okay. There is some quote" newness" to this, but when I read through the MDR, not so much the first time, but maybe the third or fourth time, it just started to click. It made a lot of sense. Now, some of it seemed like it was a little egregious, and a little overboard at times, but then if you take a moment to understand the Genesis of how the MDR came to be, there were lots of factors that influenced that. Not the least of which were some device scandals that took place in the EU. So when you start to factor that in, you realize," Oh, there's some people, some companies that weren't on the up and up, and maybe tried to cut a little corners here and there." Unfortunately now that becomes rules that the rest of us have to follow. But as a patient, as a potential healthcare consumer... to me, I'm encouraged by that because of especially the postmarket responsibilities that companies now have. And hopefully they should be doing anyway, because it just makes good business sense. But it is new, to your point, and with Brexit and all these sorts of things. So you definitely need someone who's knowledgeable and has expertise in this, and I know that's something that you do all day every day. So I would encourage folks, if you get stuck in any way, shape, or form, definitely reach out to Adnan and Simplimedica.

Adnan Ashfaq: Yeah. I mean, it's good that you pointed out your experiences with reading the MDR itself, and specifically the point that you've made about public safety. Because people need to understand why the regulations actually happened since 1993. And firstly, yeah, public safety had to become much, much more transparent, because there were these cases that were happening with individuals being traumatized, and even death taking place, and failure of the efficacy of my devices, which were not tested appropriately. But secondly, also because of the leap in technological advancement. The directive was outdated, and software AI, and machine learning and all sorts of things that have happened, it needed to be caught up with. And we are at a good point now. The thing that amuses me the most at the moment is, recently the UK have put out a public mandate for consultation on the future of regulations for medical devices here in the UK. And if you look at some of the questions that they're asking the public, all of the answers are in the regulations.

Jon Speer: Yeah.

Adnan Ashfaq: So why ask for a different directive or regulation, and just adopt the medical device regulation that the Europeans have. It's all there, the questions are all answered there. I just completely get baffled why we're going through this process, but what can we do?

Jon Speer: Well, sometimes it feels like the more we try to make changes, the more it stays the same. But anyway, that's all a whole different topic probably for a different day. But I mentioned the MDCG guidances. Folks, I want to let you know, I'll include a link to where you can find those in the notes that accompany this podcast, so you'll be able to check that out. But if you just type MDCG into a search engine, look for the ones that tie to Europe, and good chance that you'll be in the right spot. I was just perusing that as Adnan was mentioning, I always forget about resources like that, but lots of really great resources there. And then there's other areas where you can get information too, that are applicable like the IMDRF has a fair number of guidances that generally compliment those types of things as well.

Adnan Ashfaq: Yeah. If it helps, I also have a newsletter, which has just been issued out-

Jon Speer: Oh, oh, right.

Adnan Ashfaq: -which has got all of the links to the MDCG documents as well. And that might be handy if it's any way of getting it to your audience.

Jon Speer: Absolutely. Well, we'll see if we can figure that out. Maybe we can include that in the link as well, but I'm guessing if folks visit the Simplimedica website, there's an opportunity for them to sign up so they can continue to get those exciting updates, right?

Adnan Ashfaq: Absolutely.

Jon Speer: Yeah, sure. So the last little bit that I want to chat with today before we wrap up, most of our conversation today has been somewhat MDR focused, but you did mention earlier on in in the conversation, about IVDR. As we're chatting today, we're literally just a few months away from IVDR technically going live, and I think that's slated for May, 2022, correct?

Adnan Ashfaq: That's right. And I think there's a kind of fingers crossed in hope that that's going to be pushed out again, just like the MDR has been pushed out, and I think there has been a case that's been stated. I think some independent organizations have done that. There's been other voices, which are industry voices, that have tried to present a case to the European Commission to try and extend that out another year. I am actively working with some IVDR businesses to try and make sure that they meet the date of application for May, 2022. Regardless, there's continuous challenges. And that is one of the big challenges with IVDR, which is different from the MDR, is that you need to have for high risk diseases for the class Ds. Now the four classifications, A, B, C, and D, and D being the highest classification of high risk devices, need to have an external reference laboratory to review the files that are being created. And those are not even in place, even to this date. And that really is concerning. With only six IVDR notified bodies, that is concerning. And I think there's a case that's being made, to try and see if this can be pushed out.

Jon Speer: Right. Either way, I think the thing I'm hearing from you is, if I'm a company that's an IVD company... And I think the other interesting thing for folks to realize with IVDR is, we talked about the MDR evolving from the MBD in 1993. Obviously technology has changed, and now more products might be considered a medical device today versus what they would've been back in 1993. Well, that is most definitely the case with IVDR. It is a much bigger umbrella, if you will, of types of products that are defined as IVDs. So what I'm hearing you share, and I think it's great feedback, or input, or suggestions, if you are an IVD company or you think you might be an IVD company, or even if you don't think you might be an IVD company, now is the time for you to do your homework, your due diligence. There's lots of things that you can do in the meantime to be prepared, even if there are other parts and pieces that aren't exactly clear, or known, or identified yet from the European Commission set of things, there's still a lot of things you can do as a business to be ready for if and when those moments happen.

Adnan Ashfaq: Yeah. And just another point on that as well, which companies have. With the rules previously, all we had with the IVD directives was two lists, an A and a B list. So if you weren't on those lists, you were self declared. So a lot of those companies had self declared in vitro diagnostics, not having to have notified bodies. And suddenly now you've got those all switched to requiring a notified body. And now you've got four classifications, A, B, C, and D. And many of those self- declared have been jumped up to As, Bs, and maybe even Cs, in some cases, and that's really caused a lot frustration. And that's where the challenges, the workload that's cut out for these companies, that have suddenly got to now have technical files, which will be audited. From a self- declared, that's a very big jump up.

Jon Speer: Sure. And then, I appreciate all your insights that you've shared today. Any final words of wisdom, tips, pointers, thoughts that you'd like to share before we wrap up our conversation?

Adnan Ashfaq: Yeah. So, I always say the regulatory pathway is an absolute maze, and it's in a conundrum of terminologies. And even for regulatory consultants like me, I've been in the industry for 22 years, I'm still trying to figure out some of those terms. Try not to go alone. You're not alone, we are all in it together. There's lots of companies out there that have done it. You can learn from them. Consultants like myself, we work with lots of different companies, and we see the good, the bad and the ugly. And that's why we are able to try and help the weak to benefit from the strong. Those strong companies will not give you the insight, but because we've seen it, and we've got the best practice, we can give you that insight. So my advice really is to try and build that, and make sure that you've got skilled resource. And it's not just me saying that as a consultant, if you are hiring people, hire people with a skill that they can basically hit the road running. Cause that's what you need to do now. It's not something that you can sit, and wait on, and educate your self on over the next couple of years. You need to hit the road running.

Jon Speer: Yeah, I think that's very important for folks to hear because obviously, Adnan and I today are talking about some of the regulatory changes in the EU, but tomorrow it might be regulatory changes in Canada, or regulatory changes in the US, or what have you. I guess point being, this is a constant thing that we will be dealing with forever and ever in the medical device industry, is the changes. Regulatory changes that are frequent. They're very, very frequent, and you have to be able to roll with it. You have to figure out a plan, and strategy, and how you're going to address that, so great advice. Folks, Adnan Ashfaq, Simplimedica, check it out. Simplimedica.com, great resource to have in your corner for sure. And as always, thank you for listening to the Global Medical Device Podcast. We're number one in the medical device industry, and that's because of you. So thank you so much. Greatly appreciate you being loyal listeners and sharing the word with your friends and colleagues. You keep doing so. And as always, this is Jon Speer, the host and founder of Greenlight Guru, and you have been listening to the Global Medical Device Podcast.

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The Global Medical Device Podcast powered by Greenlight Guru is 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.

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