Is the widespread panic over the EU In-vitro Diagnostics Regulation (IVDR) justified? For many device professionals, the one year countdown to the IVDR deadline in May 2022 is almost here, causing much anxiety about whether compliance is even possible.

In this episode of the Global Medical Device Podcast, Jon Speer and his guest Joanne LeBrun, VP of Quality Systems at MDC Associates, shine light on EU IVDR transition concerns and the challenges the medical device industry faces, like the notified body shortage.

 

LISTEN NOW:

Like this episode? Subscribe today on iTunes or Spotify.

 

Some highlights of this episode include:

  • Why are some notified bodies not interested? There’s a ton of work, audits, and corrective actions. They don’t view it as necessary to move forward and pursue.
  • First, notified bodies plan a wait-and-see approach to find out how the EU MDR goes on May 27. The notified bodies are overwhelmed and resources are limited.
  • The EU MDR has more constituents involved and is a bit more straightforward to implement than the IVDR. The IVDR has less constituents but more things that are different, such as product classification.
  • The opportunity to self-certify for MDR has passed and certain notified bodies are no longer accepting new clients. You can contact your authorized representative about cut-off dates to get your CE mark.
  • Even if you don’t have to submit a technical documentation file, you still need to have one and review it constantly. Make it part of your change controls,
  • For ISO/MDSAP certifications and audits, do not have duplicates of files and documentation. Only have one source of information or you are setting yourself up for failure and will be out of compliance. 
  • Notified bodies are not designed to teach regulatory and quality professionals what they should know to be ready. Prepare and reach out before it is too late.

 

Links:

Joanne LeBrun on LinkedIn

MDC Associates

FDA - Medical Devices

EU IVDR

EU MDR

Notified Bodies

New Approach Notified and Designated Organizations (NANDO)

ISO 13485:2016

ISO 14971:2019 

ISO/TR 24971:2020

Medical Device Single Audit Program (MDSAP)

Overview of the 510(k) Process

Allison Komiyama from AcKnowledge Regulatory Strategies

Global Medical Device Podcast, EP 193: Quality Management for IVD Devices vs Medical Devices with Joanne LeBrun 

Greenlight Guru Academy

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

 

Memorable quotes by Joanne Lebrun:

“One of the conditions of going live for the IVDR is that they have seven notified bodies by the time we’re supposed to go live. They have a year to get more notified bodies.”

“I think that notified bodies are very overwhelmed.”

“While the MDR has more constituents involved, I think that it’s going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents but way more things that are different - particularly product classification.” 

“That honor system is now gone, and we all have to keep up on it. You really do need to update your technical file all the time.”


Transcript:

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: So is the IVDR that's going into effect in Europe in May of 2022, is this the end of the world as we know it? Well, it is going to be a challenge and there's a lot to do if you're not on that path right now. And there are some hurdles and obstacles, even from a notified body perspective, that we still got to get through, and I'm confident that we will get through them. Joining me on this episode of the Global Medical Device Podcast is Joanne Lebrun. Joanne is very knowledgeable and has a ton of expertise when it comes to all things IVD. She's with MDC Associates, you can check them out, mdcassoc. com to learn more. But enjoy this episode of the Global Medical Device Podcast. Hello, and welcome to the Global Medical Device Podcast, powered by Greenlight Guru now with video and audio. So if you're listening to us, thank you. If you're watching us, that's great too. And if you're listening to us and you want to watch us well, go to YouTube, give it a look. We've got quite a few episodes that are up there now. So anyway, joining me today is a repeat guest, joining me is Joanne Lebrun with MDC Associates. Joanne, I'm a hot mess today. We're going to get through it though, but how's it going today?

Joanne Lebrun: Doing very well, thank you. Good to be here.

Jon Speer: Speaking of hot messes, I thought we could talk about the upcoming IVDR. So what do you think?

Joanne Lebrun: Let's do. I think it is going to be a hot mess. Well, they're not ready, and ready means that there needs to be enough notified bodies in order to do it in order to make it all happen. And the notified bodies need to be designated, which is a really huge undertaking by that notified body. It's expensive, they need quality systems, they need to get certified themselves and it's just not happening. And I've actually heard from some people, from some notified bodies, that they don't want to pursue it. So one of the conditions of going live for the IVDR is that they have seven notified bodies by the time we're supposed to go live. So they have a year to get more notified bodies ready. There's only four at this moment. Some of the ones that I really like to work with aren't even going to pursue it.

Jon Speer: Why do you think that is? Have you heard any color or commentary on why of these notified bodies are not going to pursue that?

Joanne Lebrun: I think it's just a ton of work. I think that they've got to be audited, people have to come in and do all of that, and then they have their corrective actions. It's kind of like everybody else, I don't think they really see the need to do it. I think the other thing too, is that the MDR is going to be effective in 30 days, 36 days, something like that. And I think everybody wants to see how that's going to go before the IVDR does their thing. So I think they still need to figure all that stuff.

Jon Speer: Yeah. And folks listening, the time of the recording of this is about 30 days. So I think the official day of MDR going live is the May-

Joanne Lebrun: May 27th.

Jon Speer: 27th, 2021.

Joanne Lebrun: May 26th is the last day, May 27th is the first day.

Jon Speer: All right.

Joanne Lebrun: So I think we're all waiting to see exactly how that's going to go before the IVDR can figure out where we're going to go for another year.

Jon Speer: Yeah.

Joanne Lebrun: We'll see how it all happens. It's interesting.

Jon Speer: I think some of those statements that you made about not being ready and not enough notified bodies, if we go back in time to maybe let's just say this time 2019, I think we had the same concerns about MDR.

Joanne Lebrun: Indeed.

Jon Speer: And I guess it's irrelevant at this point, but I was always curious, had the May 27, 2020 deadline actually we stuck to that, what would have happened? I guess it's a moot point because it didn't. Do you feel like the MDR is ready?

Joanne Lebrun: I think they're closer to ready, I think they've had a little bit more time to be ready. But we'll see. I think that notified bodies are very overwhelmed and I don't know that they really know how it's going to be going. I think some people have been ahead on it, obviously, people do have their CE marks ready to go. A lot of people with CE certificates have extended. There was the allowance in the regulations to extend through 2024. So I think there's a lot of that. And honestly, I think while there's a lot that's going to change for the MDR, the classifications haven't changed as much. They've changed, but not so much. It's not so drastic. So I think while the MDR has more constituents involved, I think that it's going to be a little more straightforward to implement than the IVDR. The IVDR has less constituents, but way more things that are different, particularly product classification.

Jon Speer: Yeah, product classification's huge and some of what I've heard too is because of the IVDR, that a lot of companies and technologies and products that weren't previously regulated now are going to be.

Joanne Lebrun: Yes.

Jon Speer: It seems like though, if I were a notified body, I get there's barriers to entry and there's a price to play, so to speak. But it seems like there would be a lucrative opportunity if I would actually go through that process.

Joanne Lebrun: Yeah. You would think so. Very frankly, and I'm sure everybody out there is going to recognize all of this. But what was happening earlier was there was no barrier to entry in the EU. And so as products came to market or even closely ready to market the CE mark would be obtained. And I know there's a lot of you out there that haven't sold anything yet on that CE mark. So I think there's going to be a decision, why go any further when we haven't sold on that CE mark? Sometimes you can get it just to be able to demonstrate that you've gotten to that point where you could have gotten it with your product development, but nothing really happened. So a lot of products are going to fall out of the market. And I don't know if it's a huge loss because I'm not really sure that they're getting used. But at the same time, that's going to be a statistic. And that's going to get discussed that products are coming off the market. If there is a certificate, if you have a certificate that's not to self- certified people, then you can apply with your notified body, and hopefully the notified bodies are still doing this, to extend your CE mark through 2024, or whatever they're willing to give you. And if your CE certificate already expires sometime after the due date, as it were, then you can use that expiration date still.

Jon Speer: Let's talk a little bit about that. So imagine I'm working with a notified body that's still good with the IVDD and not planning to pursue the IVDR and I get this extension for a CE certification, let's say it's through 2024 or at least past the 2022 deadline. But yet, this notified body isn't in the business anymore. What does that mean?

Joanne Lebrun: Right. They're still in the IVDD, they're just not in the IVDR and they were reputable at the time. I think it's going to be honored. I haven't really heard anything about that, but it's an interesting quandary. I think they're going to honor it just because, it's still kind of a hot mess and not really anybody understanding where it's going to go. But you have a certificate and that's the important thing is that you have that certificate with that expiration date. And so therefore you've got that. But those of you who are self- certified, which means there is no certificate, everybody needs a CE mark by May 27th, 2022, which is just a year away. And there's a lot to do for that. I'm sure everybody's really struggling with that. There's quality systems things to do, there's regulatory things to do. There's probably studies that people need to do. Speaking from at least my own experience, if our clients had done the bare minimum to get through the EU, that bare minimum really isn't going to fly anymore. So there's a lot more studies that need to get done to be able to meet the regulations. It's a lot.

Jon Speer: Yeah. So let's imagine I'm in that position where maybe I could self- certify. Do I have time to do that before May, 2022? And can I do that, I guess, maybe is the bigger question.

Joanne Lebrun: Yeah. With MDR, there was that opportunity through December of the year before. So contact your authorized representative and ask them if they're willing to do it. I don't know what all of their cutoffs are at the moment. But for the MDR, the cutoffs were December. So it very well may be that you could still get your self- certification through December. And there is a caveat, it's written that you can place sales of your CE marked stuff, whether it's certified or not, you can place sales for that stuff before the due date and still meet that demand. But you have to actually have those sales. You can't just say," Well, everybody's going to want a million of these." But you actually need to make the sales. And then you have the ability to be able to fill those sales. So you can buy yourself a wee bit of time by getting those sales together by May 26th of next year, and then fill those sales while you're trying to get your CE mark together. There are certain notified bodies. The biggest one out there at least in my opinion, sorry for the other guys, but they're not taking clients anymore.

Jon Speer: Wow.

Joanne Lebrun: So then there were three. And then as soon as the next guy gets really busy, then there will be two. And so I really don't know what they're going to do. It really is, there's a resource problem.

Jon Speer: Yeah.

Joanne Lebrun: And I don't really have my ear to the tracks or anything. I don't really know what all the decisions are and all that sort of stuff, but it is a big deal. And I don't know what's going to happen there. If you have a notified body that you work with and you are going to move forward, apply today, get in there. One of the big rules that were different... Every time I look up, it seems like my necklace is slowly moving around my neck. If you have a notified body and you're in there, get in there. One of the new rules is that you are only to apply with one notified body. It used to be we could apply with three, get quotes and all that stuff. No more. So you need to apply with that notified body. They need to accept you. So it's no longer a one way situation, it's actually a two- way street and they need to accept you. And they need to have been designated for your product code, which there are product codes. You can look by notified body, what product code they got designated for.

Jon Speer: Is this, not to confuse product code jargon, but is this like the GMDN?

Joanne Lebrun: GMDN, kind of sort of, but it's a different list.

Jon Speer: Okay.

Joanne Lebrun: They don't really publish the list, but you can see at least what codes notified bodies have their designation for. And they're not allowed to take on a client that's not in their designation. So I don't know how limited everybody is, I haven't done that research. So they have to accept you. You have to apply with them. And then, and only then, can you find out is your plan solid to submit with them and you're reserving your spot. I know at least one are accepting clients for IVDR. I presume all four of them are. There's a database called NANDO. It's NANDO, and that's where the notified bodies are listed. So if you work with one of the big three, big four, you're good. If you don't, you're going to be faced with getting another notified body, or I would definitely contact the notified body and ask them what their intentions are. By now, they know their intentions. And I did have one that I really love to work with and they said that they did not intend to continue. So that kind of messes things up a little bit.

Jon Speer: Yeah.

Joanne Lebrun: It's nice to have it all in one package. You don't have to have it all in one package. What I mean by that is I've always thought of as a notified body, as providing ISO certification, providing CE mark and doing all of those things for you, but it's not really the way it goes. It really is that there's a registrar who gives you the ISO 13485. Then there's the notified body that gives you the CE mark. They also need to be sure that you're 13485 or at least meet the quality systems in the regs. And so either you get one extra audit or you try to work it all in at the same time, and that's really been the challenge.

Jon Speer: And I think that that last bit that you explained is a little bit confusing to folks. And in fact, let's come back to that after I take a quick break. So I want to remind folks, I'm talking with Joanne Lebrun, with MDC Associates. Joanne, tell the folks a little bit more about MDC and a little bit about your background. It's clear to me after we've talked a few times and hearing you the recent Greenlight summit, that you have a wealth of knowledge when it comes to all things IVD. So tell the folks a little bit about you and MDC Associates.

Joanne Lebrun: Yeah, absolutely. So MDC Associates, we're located in the Boston area. We've been in business, working on 35 years now. And we do a lot of IVDs. I'd like to say we specialize in that, but we do have a couple of medical device clients. But we really concentrate very heavily on in- vitro diagnostics. We do clinical studies and regulatory consulting all combined into that. We help people with their quality management systems, including implementation with Greenlight Guru, which we're doing a lot of right now. And we also do implementation training services for small analyzers.

Jon Speer: Awesome.

Joanne Lebrun: So instead of salespeople going out and doing training on analyzers, especially with the reduction of traveling these days, we do that through video. So that's a pretty cool service. Definitely let us know if anybody's out there who needs that.

Jon Speer: Sure, absolutely. And folks, if you want to learn more about MDC Associates, go to their website, mdcassoc. com and reach out to Joanne and the team at MDC and they'd be happy to help you out.

Joanne Lebrun: Absolutely.

Jon Speer: Want to remind folks too, while we're taking this quick break, that Greenlight Guru, we have the only success platform designed specifically and exclusively for medical device and IVD companies. We'll talk a little bit about the distinction. We've actually talked about that before with Joanne, but we have a medical device success platform that helps you address all the needs from a design control, from risk, from document management, change management, as well as all those quality events, things like CAPAs, complaints and nonconforming products, et cetera, et cetera, et cetera, all in one platform. If you're interested in learning how the Greenlight Guru medical device success platform can help you become more successful with all of your medical device endeavors, including pursuit of IVDR, then I would encourage you to check it out, www.greenlight.guru Learn more. So Joanne, right before we took a break, you talked about registrars and notified bodies and all this sort of thing. And I think this is confusing to people because I think generically, everybody's like," Oh, I need my notified body to come do my ISO certification." But that's not really who does it. Now, I think the confusing part of it, usually the firm that you hire to do one or the other has resources that can do both. So maybe can you unpack that a little bit and provide a little bit of clarity?

Joanne Lebrun: Yeah. absolutely. Yeah. We used to refer to notified bodies as one big source or one big resource and service. But they actually do a bunch of things. And as you said, they can provide all these services, but you can also go to different companies to be able to get these services. One thing that we all know is that the quality system, it's the best if you can get an ISO certification. That means that your quality system has been looked at, and it is compliant with ISO 13485:2016, which are the quality system requirements in the EU for quality systems. And there's also another little tag on certification that you can get, which maybe we can talk about another time, which is the MDSAP program, which is five different countries, including the United States and Canada, that combines all of those requirements between those five countries together. So a lot of people get the ISO certification and the MDSAP together. So that's what those people do and that's what the registrars do. They give you your ISO certification. The notified bodies, particularly their main purpose, is to, well you might disagree with me, but I think their main purpose is to give companies their CE certificate. Right? And so part of being compliant with the regulations to get a CE mark includes having a quality management system.

Jon Speer: Right.

Joanne Lebrun: It's very nice if you have an ISO certificate because you can get there a little bit easier because you have the certificate. But it depends on who's giving you their certificate inaudible. So the notified bodies also need to confirm that you have a quality system. So you're getting it from two angles if you use two different companies. And then they also have that delightful unannounced audit where they'll come and show up primarily to look at your technical file, to make sure that it's always being updated. And also production, they'll often want to see a lot being produced if they can catch it during that unannounced audit. So there's also that. There's a little bit of controversy with the new IVDR as to whether or not, so with the IVDD, there were three classifications, there was Annex II List A, Annex II List B, and then everything else. What they've actually done, and it's not all that complicated, but they did rule D for Annex II List A, rule C for Annex II List B. It doesn't 100% match, but you all know what I mean. Then they had all the things that are not certified and then rule B is everything else. And that everything else went from self- certification just list it with an authorized representative and you're done, to submit technical documentation to a notified body for your CE mark, everybody freaks out. So that's the really big difference. And I believe, and it's not in the regs and it's not specifically not in the regs. So I'm not really sure where it's going to go, but I do believe that the unannounced audit is not going to happen with the rule, with the class B products.

Jon Speer: Okay.

Joanne Lebrun: I think it's going to ease up on the notified bodies a lot, because I don't know if they're going to be able to get to all of those people to do that. So anyway, that might not be there. But there is a big difference in the services that they provide. And if you think of it in an FDA perspective, not to go all FDA on everybody, but the 510( K) s are offered through the federal government or the federal department in DC, whereas the compliance is done locally by all of the different districts. Yeah. So it's kind of similar in that way that these notified body has registrar auditors and then they have the technical reviewers else- wise. It's a big change though, for the notified bodies as well.

Jon Speer: Yeah. I think one of the other things that you just mentioned, I know there's this, I'll say it's a myth, that a lot of companies, both from a medical device and an IVD perspective, like," Oh, it's class one self- certify. I don't have to prepare a technical file." Like," Whoa, you absolutely do." Just because you don't have to submit it to somebody, you absolutely need a technical file. And do you think this is one of those reasons that the people are up in arms?

Joanne Lebrun: Yeah, for sure. I think that when you go through a technical file review or a technical documentation review now, even before the regs are out there, everybody's already stepped up their game. And so the review, we've submitted technical documentation that got reviewed before, resubmitted it, completely different game. It's a different review. So everybody has stepped their game up for that. And so it's that honor system is now gone and we all have to keep up on it and you really do need to update your technical file all the time, not once a year.

Jon Speer: It's living.

Joanne Lebrun: Yeah. Yeah. Make it part of your change control so that every single time you make a change, you say," Hey, is there a risk involved there?" You're updating your risk." Is this a change to our technical file?" Go ahead and update it.

Jon Speer: Yeah. And a tech file, I assume is more or less still following the STED format.

Joanne Lebrun: I don't know what the STED format is.

Jon Speer: It's the 20 sections.

Joanne Lebrun: Oh, yeah, yeah, yeah. Yeah, yeah, yeah. It kind of does. There's a little bit more involved there. But the one thing that I think people make a mistake about with DMR, or medical device file, whichever your terminology is going to be, DMR is device master record through FDA and your technical file, one mistake that a lot of people make is they'll keep duplicate copies, triplicate copies, quadruplicate copies in so many different places.

Jon Speer: Yeah, that's a bad idea.

Joanne Lebrun: And that is a nightmare because because then this doesn't match this, which doesn't match that. So checklists, Greenlight Guru is great because it brings it all together, which is super. If you're keeping binders of stuff, guys, stop doing that.

Jon Speer: Yeah, that's crazy.

Joanne Lebrun: Yeah, make yourself a checklist, at least. So what we do is we say, with manual clients, we'll say," What needs to be in that technical documentation? Where is it located?" Leave it and then constantly update those documents. Therefore you're constantly updating your technical file or technical documentation.

Jon Speer: Yeah.

Joanne Lebrun: And again, with Greenlight, if you can link it all together and tie all that stuff together, it's way easier because then it's definitely being updated for you.

Jon Speer: And just to elaborate a little bit on that, Greenlight has intentional functionality to try to simplify this. You can assign metadata tags and you can set up some custom views and an item, an artifact, a record, can be located at multiple different views. But the source is there's only one source. So if it needs to be updated, then it gets updated everywhere it needs to be. But if you're not using Greenlight, that's fine too. Take Joanne's tip here. Create, I guess, a table of contents with pointers as to where the source is located. But do not, please do not put duplicate copies in multiple locations because you're going to be out of compliance the first time you make a change, because you'll forget where one of the locations is, and it's just a mess.

Joanne Lebrun: Yeah. Yeah. You just set yourself up for a failure.

Jon Speer: That's an auditor, trying to think of the right way to describe it. An auditor would be super excited about that opportunity. I had to remember to keep it PG or keep it G on here, right? But yeah, an auditor is going to be excited about that. They're like," Oh, you've got duplicate documents stored in multiple"-

Joanne Lebrun: Let's check those out. Yeah.

Jon Speer: They're going to be there for days.

Joanne Lebrun: Yeah. And you want to keep everything as surfaced in an audit anyway. So you don't want that to start going into that rabbit hole and getting yourself into trouble.

Jon Speer: Yeah.

Joanne Lebrun: Yeah. But every time they walk in, they expect to see those updates. What's interesting and used to confuse me a lot is during the ISO audit, we would want to always show that. And they're like,"No, no, no, no, no, we're not here for that." And so they really are very specific about what their scope is. The other thing that's really weird, and I know it's not the topic of our conversation today, but the one thing that I just figured out, which is crazy, I've been doing this forever, is the difference between the ISO 13485:2016 certificate and the EN ISO 13485:2016 certificate.

Jon Speer: Okay.

Joanne Lebrun: They're different. So everybody, I recommend you just do all of it. If you're going to do ISO 13485: 2016/ MDSAP, that's fine, that's great. But you're going to want to do the EN ISO as well. The thing that's the difference is there's an Annex Z. Okay, we all say Z, but of course it's Europe, so it's Annex Z. And in that Annex, it shows you how to be compliant with the IVDD and the IVDR and where the differences are between the ISO certification and the quality system that's required for the IVDD and the MDD. I said IVDR and I didn't mean it. They're going to have to update that reg or at least that Annex coming up because now it's a whole new different game, and I haven't seen that yet.

Jon Speer: Yeah.

Joanne Lebrun: It was news to me.

Jon Speer: One other, I guess, thing to be aware of if you're on the IVD space was with respect to risk management and specifically there's a standard out there, hopefully you all are aware of, known as ISO 14971. And the latest version is 2019.

Joanne Lebrun: Yes.

Jon Speer: You'll read that standard and you're like," Okay, why is Jon saying that this is important to IVD?" Well between that and its companion guidance document, which is ISO/ TR 24971: 2020, there are annexes that are specifically dedicated to IVD. So you'll want to review those in some detail because I don't think there's a huge change, but the committee felt it was important, IVD was important enough that it has its own dedicated annex. So that says," Hey, that's probably something to pay attention to."

Joanne Lebrun: Yes. And all auditors have their hot list when they come and see you. And that is definitely one of them, is to be updated to the new ISO 14971 and predict they're going to know if you have an updated, if you're still calling your risk benefit analysis. That's the key because the benefit risk analysis is now the new term, and if you don't use that new term, then they're going to really dig in and make sure that you've done your updates. And they actually talk about it in the new regulations in the IVDR in the MDR.

Jon Speer: They do.

Joanne Lebrun: They talk about the benefit risk analysis. They really make some assumptions that you're going to have some tie together between all of these things.

Jon Speer: I mean this with, I guess, medical device quality regulatory interest sincerity that the IVR, is somewhat of a fascinating read. It's quite a lengthy read, but I think everybody that's involved in this, you should be aware. Don't just assume that," Oh, my regulatory person has this under control." They probably do, but you should give yourself, educate yourself a little bit on the topic. At Greenlight Guru, we have other content, other webinars, podcasts, et cetera. So those are great places to start too. But Joanne, as we wrap things up today, I guess I'll pose this question. Should we be panicking right now?

Joanne Lebrun: Don't panic. Don't panic, but get moving. But don't panic because panic is just going to make you sloppy and you're not going to know what you need to do. But definitely get moving. If you have a notified body and your notified body is one of the four, apply with them as quickly as you can so that you get your spot. And then what I would do, if you are in charge of clinical studies, read. The IVDR will put you to sleep and it is a really interesting read, but I would say read the annex about your studies and make sure that if you're an R& D guy or if you're doing your clinical studies, make sure you meet those because you probably have some work to do to be able to come up to speed there. They're very specific, especially in the IVD world, about exactly what they want to see. It's kind of like submitting a 510( K). So if you haven't submitted your 510( K), you could be left stranded. If you have submitted your 510( K), it's not as big of a deal because you probably have that information because the FDA has been asking for that information.

Jon Speer: For sure.

Joanne Lebrun: So there is that. So if that's what you do, check that out and maybe just target that area so that you at least read that through. There are a lot of cross references in the regs, check them out. I always want to blow them off because it's like," Oh, I don't want to go back and forward, back and forward." It kind of makes sense. And if you don't do the cross- references, you're going to get stuck. So look at those and that sort of thing. If you're a quality systems person, understand the quality system stuff. If you're everything to your company, read all the regs. But we've dissected them. We've read them word for word, we've associated them, we're writing documents, we're really trying to help our clients to be able to be ready because it is a lot. And they require that you have somebody that's designated as the regulatory person. And if you're a small company, which is a pretty huge number to be a small company with them, I don't remember what the cutoff is, but it's millions of revenue, then you can have somebody like MDC or any one of the other people who do this to be representative in your regulatory arena. And I have to say at the very beginning, that might be helpful because there's a lot to navigate here. I work with a lot of really, really talented people and we're all working together and networking to make sure that we all understand what we've read the right way. So this is very much a community- based situation, as opposed to" I've read the regs, I got it." It really is a lot.

Jon Speer: For sure.

Joanne Lebrun: And so, you don't want to get caught. I think I've said before in this, and as well as other seminars, if you do get caught unaware, unprepared, you're going to end up paying the notified bodies a bucket load of money. I'm trying to keep it clean there too. You are just going to pay so much money to be able to pay for them to teach you what you're supposed to have already known. And it's like somebody's salary what you're going to end up paying. So you might as well prepare ahead and make sure that you've got what you need and reach out to somebody who can help you to do that because really, if you wait till now, next year, you're too late, for sure.

Jon Speer: And I think that last little bit is important regardless of what type of product you have and what type of market you're pursuing. I think a lot of times, companies have sort of viewed regulatory bodies as the teacher checking my homework. That's not really their role. You should be checking your homework way before you turn it in and don't expect for that regulatory body, whether it be FDA or a notified body or a registrar, to guide and direct you as to what to do next.

Joanne Lebrun: Yes.

Jon Speer: That's not the time. You want that moment to be smooth. So just keep that in mind.

Joanne Lebrun: Yeah, yeah. That's really good advice.

Jon Speer: Yeah. Joanne, any final thoughts before we put a wrapper on today's episode?

Joanne Lebrun: I think we're all in for a rough ride this next year.

Jon Speer: We're going to get through it though. We're going to get through it.

Joanne Lebrun: Don't panic, it's going to be fine. I really do think, read the regs, read them out loud. And I know that sounds silly, but I do it every single day. The more you read it out loud, the more you're like," Wait, what did I just say out loud? That was weird." And so there really is a lot packed in there. They've done a really good job at writing these regs. There's not a lot of ambiguity compared to the other regs, but it's really worth the read. And it's our lives, so we got to do it.

Jon Speer: Yeah. Maybe companies could start little book clubs where they're going to read a particular annex from the new regulations. But I say that in jest, but something like that is good. It's not a bad idea. I actually heard of another person I know pretty well, Allison Komiyama from AcKnowledge Regulatory Strategies. She shared with me recently that that's what they did with all standards or new guidances. They get their team together and they read it. They have a book club. That sounds nerdy, but it's important.

Joanne Lebrun: It's super nerdy. Yeah, it's almost like a script read through. You can sit around the table. We literally, we did it through Zoom of course, but we sat and we each took a section and we all read it out loud to each other. And it really, really helped because sometimes I'm thinking about," Yeah, I got to go buy some bread and I got to go walk the dog," and I'm thinking about everything but the really technical stuff in front of me.

Jon Speer: And I think that would help a company with their institutional knowledge or interpretation on certain things. So at least if you're coming together or presenting the same, or a consensus type of understanding from an organization standpoint, that's good. It's better than having six different opinions and then having all these discussions with notified bodies and regulatory bodies that it's all over the place. So at least get your internal act together and get on the same page.

Joanne Lebrun: Yep, absolutely.

Jon Speer: Well, Joanne, thank you so much.

Joanne Lebrun: Thanks Jon.

Jon Speer: It's always a pleasure to have an opportunity to chat with you. I always learn at least one or two things, and today is no exception. Folks, we do have time, but not a lot, to get prepared for the IVDR. If you're just going to sit back and wait and hope that the EU pushes out that deadline, that is not a good strategy. Get your act together. Reach out to folks like Joanne Lebrun with MDC Associates, they can help you put together a game plan and a strategy so that you can be successful because just assuming that it's going to be delayed, assuming that this is going to happen and that's going to happen, you should assume that it's going to happen and make sure that you're in the best possible situation for that May, 2022 date. It will be here fast, so get prepared. And as always, thank you for being a loyal listeners and watchers of the Global Medical Device Podcast. For those of you watching, be sure you subscribe and click the bell notification so that you get alerts anytime a new episode is live and ready for your consumption. You're keeping the Global Medical Device Podcast as the number one podcast on the medical device industry, and I thank you for that. So as always, this is your host and founder at Greenlight Guru, Jon Speer, and you have been listening to the Global Medical Device Podcast.


ABOUT THE GLOBAL MEDICAL DEVICE PODCAST:

medical_device_podcast

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.

Like this episode? Subscribe today on iTunes or Spotify.