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Agreement was reached on the eagerly awaited new EU Medical Device Regulations (MDR) and In-Vitro Diagnostics Regulations (IVDR) earlier this year.
This represents the single largest regulatory change in the EU in decades and it will affect ALL device manufactures selling in Europe.
The new MDR and IVDR are expected to be formally published any month now, and there will be a three-year transition period to be compliant.
Today we’re talking to Richard Young, the managing director of Acclaim Biomedical Consulting. He’s speaking to us today about some of these changes in the EU. With over 20 year in the medical and in-vitro device regulation industry, Richard has good insight on what these changes are, how they came about, and how the new MDR and IVDR will affect medtech companies.
“Clinical evidence is going to be a continuous process... and the role of post-market surveillance has become a central theme in Europe.”
“I can see the [EU regulations and the FDA regulations] coming very close together.”
“It all comes down to timing and communication.”
And if you've made it this far, you're probably going to be interested in the free, 90 minutes webinar we're hosting with Richard on "How to Prepare for the New EU Medical Device Regulations." In it he will be diving deep into all the significant changes coming and how you can start preparing now.
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 worlds leading medical device experts and companies.
Jon Speer: There's one thing that is certain in the medical device industry, and that is there are always changes in regulations all over the world. In fact, right at this moment, the regulatory environment in the European Union is under some significant change. And today, on the Global Medical Device podcast, I have Richard Young of Acclaim Biomedical. And he is going to talk with us today about some of those changes that are pending in the European market with respect to the medical device and In Vitro Diagnostic Regulations. So, sit back, relax and enjoy this episode of The Global Medical Device podcast.
Jon Speer: Hello, this is Jon Speer and welcome to the Global Medical Device podcast. Ladies and gentlemen, there are a lot of changes brewing in the regulatory environment all over the world, including in Europe. And luckily for you, we have an expert on today's podcast. With me, I have Richard Young. Richard is the managing director at Acclaim Biomedical Consulting Ltd. Prior to founding ABC, Richard had more than 20 years of experience in Senior Quality Assurance and Regulatory Affair roles in a diverse range of medical device and in vitro diagnostic context. Having traveled the world honing his expertise and gaining an extensive range of industry context, Richard now feels he can independently offer a truly innovative range of services, all designed with you in mind. His goal is to provide you exactly what you want, quickly and effectively. Richard, welcome to the program today.
Richard Young: Thanks, Jon. Very nice to be here.
Jon Speer: Now, tell us a little bit more about Acclaim Biomedical and where people can find out more about that before we dive too deep in today's topic.
Richard Young: Yes, certainly. We're based in the UK. You can find a range of services and offerings on www.acclaimbiomedical.co.uk. We're really set up to bring sort of the quality and regulatory affairs, aspects of the medical devices industry and sort of combine it with a good understanding with clinical services and marketing services, as well. So, broader than the traditional consultancy but really making... Trying to provide a holistic solution to people looking to work in the European market.
Jon Speer: Right. Absolutely. Well, as you will know, you've been following this very, very closely and I wanted... We've talked a little bit, you and I talked a little bit about this. But, things are changing in the medical device and in-vitro diagnostic regulatory world in the EU and that's really what we're gonna dive into today. So, are you ready to impart some knowledge on our listening audience today?
Richard Young: I'm in my best imparting mood, Jon. We'll do the best we can.
Jon Speer: Okay. So, I guess before we get into too many details on the topic, can you just give everybody like maybe a 30,000-foot view of what's happening on the regulatory front with medical devices and IVDs in Europe?
Richard Young: Well, basically, medical devices and IVDs for that matter in Europe, have been threatening to come up with new versions of what were known as the EU directives in those two areas for the best part of five or six years. It's been very slow coming along. It hasn't happened as quickly as anybody would have hoped, but it is getting to the point where it's becoming real now. It started looking pretty real last year about June time where we had a draft of the text. Both of the new regulations come out so, big shift from a directive to a regulation which won't have to be implemented across Europe. So, we saw the very early texts after much arguing and that was refined somewhat later this year and in May time with a clear intent for that text to be turned into something that's published and becomes law in Europe. Actually, the target was this month, but being controlled by politicians and being in Europe, we are probably going to be a little bit later but they've got four days...
Jon Speer: Alright. So, when you say this month, that's meaning in September 2016?
Richard Young: Yeah. September was the original goal. I've heard a variety of possible dates on anything from this month through to January next year. So, we're just waiting on that final publication at the moment.
Jon Speer: But it's not "if", it's really when at this point?
Richard Young: Yeah. It is really when. The complication here seems to be just tidying up the language of both of the new regulations and getting them all tightened up. There were three directives in Europe. We had the Active Implantable Medical Devices Directives, the Medical Devices Directive, and the IVD Directive. They have really been consolidated down, the Medical Device and the Active Implantable Medical Devices Directive have been combined into one regulation and the Stratford IVD regulation. So, there's quite a bit of drafting going on to share the language rights and the legal sting to those rights. But that seems to be where the hold up is there.
Jon Speer: Sure. Sure, absolutely. So, I've got a couple of things I wanna dive into a little bit deeper today. I know there's a couple of these areas that have... I don't know... I'll say giving people fits, that may not be the right way to describe it, but have been, we'll say challenging maybe at times for people to begin with, and I'm sure that there's some question or concern about how do these changes, this shift from directive to regulation, how is this gonna impact some of these different areas? The first one I wanna dive into is about clinical evidence. And obviously that's been an area that's been under some scrutiny for quite some time, and there is some change and some different practices from a US perspective versus an EU perspective on this to begin with. But, how do you see that burden of clinical evidence changing with the new regulations?
Richard Young: Yeah, I think that this is probably one of the fundamental shift areas in the new regulations coming forward, especially for those people out there who are dealing with the in vitro diagnostic side of the industry. And there was quite a gap between the medical devices directives and the in vitro diagnostics directives prior to these new regulations coming out. But the requirements and these new regulations are really quite similar with a credence to the fact they are very different areas technically. And what we're finding here is, the new regulations go an incredibly long way to trying to address the fundamental issues that led to things like the ASR metal-on-metal hip implants and the fiasco.
Richard Young: There's lots of annexes and lots and lots of pages devoted to it. We can't really break it down, so the clinical evidence is going to be very much a continuous process and there's a lot of emphasis already from European notified bodies looking at a continuous process post-market clinical follow-up. We are already being asked as manufacturers to make sure we have plans in place to do that, and the role of post-market surveillance is being really ramped up to become a central theme in Europe, so that now they're continually monitoring the performance of those devices out there in a credible manner, is incredibly important. I don't think the underlying message here is in line with the risk factors associated with the device, and the more risky the device is, the higher classification, the more important that clinical evidence is, and you need to have that out there to keep those products on the market.
Jon Speer: Sure. So talk to me a little bit about periodic reporting. The post-market surveillance, the post-market clinical follow-up, this periodic reporting, these are all concepts that seem to be really just... They're not new per se necessarily, but they've been a little ambiguous, so talk to me a little bit about... Or, I'm sorry, periodic reporting.
Richard Young: Yeah, I think you're right. Yeah. Post-market surveillance in itself isn't a new concept for medical devices in Europe at all. It's been asked many years, but I think the definition has got very, very precise. The language and the fact there are specific articles describing what the expectations are, that there's both in the in vitro diagnostic regulations and in the medical devices regulations. When what we're seeing here is, as I said, this idea of continuous monitoring, and also an element of transparency, especially with the Class 2b and Class 3 devices from a medical devices perspective. And we can see this in this periodic reporting requirement that's becoming the new regulation.
Richard Young: We can see the requirement for manufacturers of Class 3 devices and so on to actually be reporting on an annual basis to the European Commission. And what's happening, what is their market experience with their product out there? And interestingly, that actually goes in with the requirement to actually have a published periodic, the periodic safety reporting and some public display of health and safety data associated with a product on the EUDAMED database which is gonna be public access as well. So think of things with transparency and making sure that clinical evidence is very solid. It really is, PMS is coming out from underneath the bed and having a big spotlight shone on it and being said... Being said very clearly, "This is your central method of actually validating your risk management assumptions and making sure that they're still valid on an ongoing basis that all call into very much interconnected and very important to managing treat life".
Jon Speer: Right. And one of the things that, there's obviously a big difference between the FDA regulatory model and the European regulatory model, and it seems like this change in the regulations or the pending changes in Europe is going to make those models a little more similar to one another, but it's still... The thing that's unclear to me is FDA can show up and perform an inspection at the medical device companies, do you anticipate that the European model will, I guess, have that teeth so to speak, or that enforcement to be able to send inspectors to med device companies, or do you see this periodic reporting being a good faith measure to help address that?
Richard Young: No, I think it's gonna be on that already. It is one of a multitude of measures and notified bodies, some of your people out there have probably already been the victims of this. The notified bodies are on a schedule of going out and doing unannounced audits already with their clients worldwide. We can see that extending out into critical suppliers to those customers over the next few years and I think the activity in that area is only going to increase. And I think that's gonna be really interesting because with the publication of the new version of 13485 this year, and the very strong hint that that standard is going to form the basis to the medical device single audit global program that the FDA is moving their guidance to meet the moment, it is gonna be the standard that people refer to in Europe as their model for compliance, it's the FDA using it for the single audit program as well. I can see these things coming real close together, and that level of scrutiny in the unannounced audit things I think sort of brings it all together.
Jon Speer: Right, right. I guess, from one perspective, I see that as there could be a lot of positives to that? We're... As med device companies we're already subjected to numerous audits, it seems like from all sorts of different bodies, FDA and our ISO auditors and other regulatory bodies across the world and supplier audits, test audits and all these sorts of things. And it seems like that single audit program shows a lot of promise, if I can address the FDA and ISO in one audit, that that might be helpful in some way, shape or form. So I'm curious to see how that gets executed in practice. I don't know if you had any experience with that today?
Richard Young: Yeah, there are people out there offering the programs at the moment, we're slightly anticipating the end of the pilot program that's due to report back at the beginning of 2017. But overall, the feedback looks pretty positive so far. And I think you're right, it'll lift an entire, a real big burden on manufacturers where at the moment, they have to furnish audits from Anvisa, and FDA, and a whole range of regulatory inputs.
Jon Speer: Right.
Richard Young: Be interesting to do... Obviously Europe isn't signing up to this program at the moment, but the papers and standards is the same. So yeah, we make it more sensible and more uniform, yeah, it can only be better for manufacturers and... They'll keep maintaining their compliance.
Jon Speer: Right. So Richard, a good percentage of our listening audience, maybe all of our listening audience, they're all about getting new products to market, in some way shape or form. New medical devices. And obviously, classification, how devices are classified is, well, it determines your path into that market. And I've always, personally I've always kind of appreciated the European model because it's historically been pretty straightforward. It's been very decision-tree oriented. I'm an engineer, I like flow charts, I can follow it... [laughter] Whereas sometimes that FDA model is a little confusing, and such, but I'm curious, do you see that there's gonna be any major changes with respect to how products are classified with the new medical device regulations and in vitro diagnostic regulations, going into effect maybe later this year, or at least soon. Do you see changes from a classification standpoint?
Richard Young: If we talk about in vitro diagnostics, I think that is a major shift for the in vitro diagnostic side of the industry because they've gone very much from a... European terms of traditional... A list, a list of products that were controlled by the previous directive, to a risk-based classification system, which we'll we be more familiar with on the medical devices. That's a big shift in the in vitro diagnostics side to the business. And they get classifications of A through D, D being your high class devices. So yeah, a big shift on that side of the business. I think for medical devices, the classification, there are more classification rules in there, and what they've had to do is add a lot of definition. So it's easier to look at... Deal with new technologies that are coming through, so there's more definitions and more guidance on how you go in there, for example, there's a lot of definition there in software products and so on... We're all into the wearables and so on these days. So there's quite a bit of emphasis from those and the situational classification of what it does. But essentially most of the expansion of the classifications on the medical device side is more associated with the fact that there's two directives and one, now, in one regulation so that accounts for 90% of the expansion of the definition and the rest is to cover new technology areas.
Jon Speer: Right, but it's still gonna be rule-based where you can follow through basically a decision tree type of approach and follow certain rules to determine the classification?
Richard Young: Yeah, the basic risk-based principles of looking at the intended use of the device, and its area of application, and then following through the sections, is still being preserved and yeah, it's pretty straightforward to go through. Yeah, it's longer now, so yeah, it pays you to sit down in a quiet room down and look through it very, very carefully, and some products move slightly. By and large, 99% of products are where they are currently, so no major shifts expected for most people. It... Much where it's true for everybody, it pays everybody to get out there and have a real good look, make sure you know where you're going in the future, just you validate that for your product. [chuckle]
Jon Speer: Absolutely. Obviously a core, a foundational component of European directives historically has been the concept of the essential requirements, making sure that your product or technology meets certain essential requirements. How much has this changed as a result, or do you anticipate this changing as a result of shifting from the directives to becoming regulations in Europe?
Richard Young: On the essential requirements, again, we got essential requirements mirrored into the in vitro diagnostic and medical device side of things, that's a bit of a new thing for the in vitro diagnostics people. But on the medical device side, on both sides, we're seeing that the essential requirements have expanded. If you look at medical devices, for example, we've gone from 13 to 19 essential requirement areas with a lot more emphasis on things like phthalates and specific material interactions with concerns about things like metal-on-metal, and PIP and PVC plasticizers and so on, either the specific sections and then that need to be spoken to by... As you go through the essential requirements. They all essentially make sense, though. It's a long process to go through and do them now, but the approaches that were taken in the past are still going to be equally valid. And you just gonna take a little bit more time to answer all the questions. There's nothing over the top there. And there's a specific section to back up the changes, the classifications of specific sections on software products now. Getting to the... Getting to those and how you use your hand-held device products. [chuckle]
Jon Speer: Yeah, I'm picking up a bit of a theme. You mentioned software a few times today so...
Richard Young: It's one of the areas, it's definitely one of the areas.
Jon Speer: You mentioned that the these changes have been talked about for quite some time. I can imagine that software and technology is probably a big motivator to finally do something about this too.
Richard Young: Yeah, I think historically, prior to sort of the PIP IAS, I think people are pretty happy with the legal framework in Europe. Then the growing dawning realization that things have moved beyond the scope of what that directive when it was already written in the 90's.
Jon Speer: Sure.
Richard Young: Could possibly envisage. And I don't think anybody thought we'd have computers that could launch a mission to the moon in our pockets. Whenever people want to bluetooth things and get data and hold the device around them. Medical as well as their TVs, so that's where it's going. And then the regulations have to be fit for the purpose to frame that. I think people, and a good example of that is the labeling sections, I think people would be pleased to see beginning of cracks opening to allow labeling to be delivered with some providers by the internet. So, now we can see that modernization to a certain extent coming through there.
Jon Speer: Sure, sure. And I can imagine there's been a lot of other economic, I guess, influences and ramifications from a number of different perspectives, that have impacted some of these decisions to change and implement the new regulations as well. Anything you wanna share about that?
Richard Young: Yeah, I thought this is probably one of the other major areas of change within the new European regulations. It's interesting, reading through all of them, that both of them use the word liability and there's lots of legal languages and concepts coming in. I think really in parallel with what's going on in the US at the moment this emphasis on distribution and this mis act of concept, the economic operator in Europe that means your distributors, your importers, and more brand representatives. And really dark into this idea is cooperation of these entity, these people, this economic operators with the authorities in Europe, and a real regulatory requirement for them to maintain traceability and control of the product as it's moved around Europe, really fix some of the UDI thing that's... You gotta say UDI on both sides of the Atlantic already, which I think is a good thing.
Richard Young: Watching we know where our products are is, briefly manufacturers too, so... Yeah, we should say. But I think we're gonna see that UDI requirements and we're gonna see a lot more professionalism I think in the distribution change, 'cause they've got a lot of legal requirements on now. Manufacturers. It's gonna be a bit of a challenge keeping control of that, but as manufacturing that distribution chain, making sure it's kept up to date and got mentored in a good manner.
Jon Speer: Yeah, I've worked with or interacted with several medical device distributors over the years. And as we say here in the United States it's... Sometimes, medical device distributors operate like during the wild west, there's not much oversight or law that impact them and sometimes, it really seems like they're stretching the limits and pushing the envelope quite a bit, to use a lot of metaphors and similes in that statement, but that it's... Distributors have been an unregulated force in our industry for a long time. And I hear that from your words, that that seems like that might be shifting a bit too.
Richard Young: Yeah, I think the days of the small distributor who has a garage full of products and an SUV trying to sell today, I think that's done. We were talking, they're gonna have a need for traceability, some blend of IT systems and control of documentation and records. That is appropriate for each ones products we're talking about, handling and distributing to like our own customers. Yeah. So I think it's gonna be pretty important for manufactures to know where that product goes after they throw it at the door. I'm predicting some of my clients in a moment there, but they're not we're just gonna need a supplier quality engineer. They should have a distributor. Which is out there as well.
Jon Speer: And a lot of medical device companies, you get to the point, they say "Oh, I can't tell you where it went. My distributor handles that", I'm like "Ugh, come on, it's your product". But that's probably a whole different topic for a whole debate.
Richard Young: It can take a while to settle that, Jon, but I got a feeling that's not gonna be a great answer in the future. Not get you into a lot of trouble with your various regulatory authorities. So yeah, and that's trying to... I think that's good. I mean, that's real good.
Jon Speer: I tend to agree. So, we've covered quite a bit about this change that's coming real soon. Anything else that you wanna add that we haven't... You think are really important for our audience to know or to think about that's looking forward with these changes and the medical device and in vitro diagnostic regulations in Europe?
Richard Young: I think it all comes down to timing and communication from that. Understanding the classifications of good devices going forwards and being real strategic and looking about which products you're going to take forward to the market under the new regime. There may be some products out there with very scant clinical evidence that you might want to push off the edge in favor of stuff that's better documented. I think there's some hard decision to be made by everybody from an established manufacturer's perspective out there. It's real, real important for everybody to have a good strategic plan of what they've got and where they're going, and really communicate well with their notified bodies and make sure that that notified bodies lined up to support them going forward. And so communication's everything in this. Documenting things really well in a controlled manner, making sure that you're communicating upwards, downwards, sideways and, hey, have a plan. [chuckle] If nothing else, have a plan.
Jon Speer: Right. Richard, I appreciate taking your time today to talk to the audience on the Global Medical Device Podcast. I wanna let the audience know that... I hope this is okay with you. If they have questions about if and what and how to do with respect to these changes that are coming and the medical device and in-vitro diagnostic regulations in New York that they can reach out to you and connect with you. And, Richard, is the best place to get a hold of you via the Acclaim Biomedical Consulting website
Richard Young: Yeah, that'd be absolutely perfect, Jon.
Jon Speer: We'll include a link in the text that accompanies this. But for those of you who are listening on your iPods or what have you, Richard, you can find more about him in Acclaim Biomedical. And the website is Acclaim, A-C-C-L-A-I-M, biomedical all one word, no spaces.co.uk, and there's a contact page, of course, where you can reach out if you need more information about this and Richard would be happy to help you with your questions. So Richard, again, thank you for being part of the Global Medical Device Podcast.
Jon Speer: And just wanna let everyone know if you need some help with your quality management system, if you need help managing your design controls, especially as you prepare for those technical files and essential requirements for the devices that you'll be bringing to the European market, greenlight.guru has a software solution that can help you with that as well. Go to greenlight.guru, request a demo. One of my colleagues will have a conversation with you and find out how we can help you get your products to market a little bit faster and aligned with the regulations and comply with all of these changes that are happening all over the world. So thank you and we'll talk to you soon.
Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...