IMDRF Initiatives: Driving Global Regulatory Harmonisation

Okay, we're started. So, Fraz's gonna be letting the people in. Hmm. As… as we go. I'm just… Running this… Last. Dit.

So you're going to be taking care of, Sean, the chat and stuff, right? Or did you want me to keep looking at it as I go?

Yeah, I'll look at it.

Okay.

What is the best way to send this? Okay, I am sending you…

But you see my presentation, right, Sean? Because I just see myself.

Yeah.

Yeah, good.

Dropping into an email the results that I got. from the query. But… You can look at… Oh, my God. I can't do this right now.

We need to get started. Sorry, trying to do too many things at once. It's 11 o'clock. Stephanie, drop your email into the chat, so that I can send you this, email real quickly. For some reason, adding you to my contacts is not enough. For Outlook. How's everyone doing?

just don't like me, because I'm not using Outlook.

How's everyone doing this morning? Anyone want to say hello while I send this email?

Hello, everybody. I'm good, thanks.

Hello, everybody.

Hello, Martin.

The best for the 20th… Six, with a lot of success. And, health, and, yes, Good, let's say, progress in the medical device market globally.

Thank you, thank you very much. Good to have you here. Anyone else want to say hello?

Thank you very much, Tilson. Hello, everybody. Good to see everybody here.

How are you doing?

Hello!

Welcome, everyone. Okay, I've sent you the email, Stephanie. of the… input that we did. So, we'll get to that in a bit. So, okay, welcome everybody. This is the first, I guess, real, Friday in Focus call that we're having in 2026. Exciting new year, lots of things, lots of things going on. As usual. And, Excited for today's speaker. I went through the presentation with Stephanie yesterday, and it looks really, really good. So, you're in for an interesting. talk, and I hope that you will, you know.

come off mute and add comments where relevant. Try to, you know, keep it within the frame of the discussion, or I'll cut you off. And but the, Yeah, so we're gonna talk about the IMDRF initiatives, the harmonization, and I'm gonna introduce Stephanie, who is gonna be speaking today. If, you wanna, ask a question, feel free to use the Q&A function, or the chat, probably the chat function, I don't know about the Q&A. And, let's see, If you need to be promoted to panelist, please put that in the,

In the chat function as well. Frah, can you check out the chats and see if anybody wants to be… Promoted, like, Leo. Yes.

Okay. In order.

Thanks very much. So, Francesco's gonna be promoting people, and… And, we're gonna get started. Before we do, I just posted on LinkedIn the roundup from last week, which has 3 upcoming webinars in it, so please check out my latest post, drop a like, drop a comment. be a pal, and let's support each other. Stephanie!

Yeah, good.

Are you? Where are you calling from?

I'm calling from Switzerland, yeah, so across the pond. In… in a place called Bieberstein, about, it's between Basel and the CERN, on Zurich and Bern, if anybody knows those locations, so… It's in the northern part of Switzerland. Northern German-speaking part of Switzerland, yeah?

Is it, is it snowy there?

No, it's sort of like slush rain. It's kind of crappy.

Pretty good.

I mean, we had snow, but today it rained.

Yeah, yeah. Where are you located, Martin?

in zoo.

And two, okay.

snow. All the hills were covered with snow, loads of snow, and it's all gone, but more's coming tomorrow. It's gonna be loads tomorrow, so…

Yeah. Yesterday, I couldn't drive. Yesterday, my car would have just been, like, on a pair of skis going down the hill, so I had to take public transportation, and even the bus didn't come home. Half the day yesterday because of the snow. It was an interesting day yesterday.

Parts of the UK is struggling as well, which is a very unusual, I know, event, but of course, we are… we are devastated because we've had up to 30 centimetres in some places, so that's enough to stop Wow. Those parts of the country that are affected, but…

Wow.

Most of us just got rain. It does occasionally happen here.

That reminds me, so, yeah, next Thursday, we're driving to Florida. Till…

Interesting.

to avoid the rest of winter.

Well, to make you feel good, the high for today is 79. It's currently 74 outside. Sorry, everybody, I now know that I'm the most hated person on this call.

We're… isn't.

Jacksonville, Florida.

Okay, we're going to Fort Lauderdale.

Yeah, so it'll be warmer down there. We're at the most northeastern portion of Florida.

Very nice.

I'm a fellow Jacksonville person. I'm also from Jacksonville, Florida. I'm based in Jacksonville. Oh, awesome! We're gonna have to meet, Catherine. Pleasure to meet you.

There you go, small world. Shall we? Okay.

I am… I listened to you from Greece at the moment, so we have here a little higher temperatures than in Central Europe. Still rain, and if you are in specific areas where you are high, you can also meet there all snow.

Wow.

Yes.

Can you guys…

Not only sea, there is also mountains.

Fair enough. Sometimes.

reading…

Greece, nice to have you.

Yeah. Super. Yeah. Stephanie? Good, I'll go for it then, huh?

Okay, here we go, here we go.

We will be very interested to listen to your presentation. Thank you very much.

Thank you. Thank you very much, Sean Smith and MedTech Leading Voices, for allowing me to present today. So, what I'm presenting today is the INDRF, their initiatives, and how they're driving global regulatory harmonization. No. Now it has to go forward. Hello! Okay, just to mention, this is for educational purposes only, it doesn't replace the text of the legislation, standards, or guidance, and it's my personal opinion as a subject matter expert. Okay, it's now… Anyways, so MedTech Experts, we offer consulting and support for medtech companies in the following areas since 2016, so almost 10 years.

We have a network of individuals bringing 20-plus years of work experience, and we want to expedite market access and the success of your medical device. And IMDRF is also about expedient market access as well, through their harmonization initiatives. So, just about me, I have over 30 years of international experience in a QMS environment, ESON 9001, as well as 13485, the QMS standards. I've had diverse roles over my career. Been an engineer. I've also been a medical regulatory officer. I've worked in clinicals. I've also worked as a researcher at the University of Calgary and University of Bern. I've also been a notified body, technical file reviewer and auditor.

And I have different areas of expertise, I've just included a few of them here. Orthopedics, trauma, navigational surgery, wound healing, dental area as well. And I have my Master of Science of Biomedical Engineering from the University of Calgary, and a Bachelor of Science in Mechanical Engineering from the University of Saskatchewan. So why did I choose this topic today? Can anybody guess? I think I gave it away at the beginning. Okay. Okay, I'll continue then.

Because you like it.

Okay, I just sort of say, let's say, what are we confronted with? Well, we're confronted with exponential growth of regulatory requirements, including new standards and guidances. Which are evolving at a fast pace. We know that some countries also don't have sufficient medical supply. And, that also IMDRF is, of course, interested that even the small countries, or the countries with insufficient funds, get their medical devices, can treat their population. And of course, what I… another reason why I'm bringing up this topic, you'll see towards the end. I'll tie it in for those people that are in the EU and have products on the EU, you'll understand further why I decided to bring this topic today.

Okay. So, IMDRF, does anybody familiar with the IMDRF before I continue? Yep.

Thanks, Tracy? Great. Okay.

Good. So, yeah, It's a voluntary group of regulatory people from different countries around the world, and their major goal is actually to harmonize and converge the regulatory frameworks together. They actually started in 2011, in a meeting in Ottawa. They're building on the work of the Global Harmonization Task Force. And the founding members, were the National Regulatory, Associations of Brazil. Australia, Canada, China, European Union, Japan, US, and World Health Organization. And what's really interesting is that it has evolved, yeah? So there's… there's… these are the management committee members, so there's even more members than what started out.

And what we have here, represents, of course, the continents and the different countries, but we also have now even more members, over 40. We have 29 affiliated members, which are listed according to continent, and we also have official observers, for example, the World Health Organization. What are some of the success stories of IMDRF? Some of you might be familiar with that, is the essential principles. That's, similar to what you see with a… Annex 1 of MDR, the general safety and performance requirements. We have the STED, Format and structure and content, which allows a harmonized technical documentation for medical devices.

We have for QMS, we have the MDSAP. We also have adverse event and vigilance codes terminology that the IMDRF put out, which many are using. In fact, the EU have now adopted that, and you'll find an MDCG on that. And we have the IMDRF reliance model, and so on. There's a lot of things going on right now that really help out regulatory professionals as we go forward. So, some of the things I've just sort of grouped together. So they're enabling reliance through harmonization convergence.

Are you sharing.

Why didn't.

Slides? Sorry, I'm not seeing the slide. Are you sharing slides? I'm not seeing them.

Yeah, I am. Does nobody else see them?

Yes.

I see.

Okay, I see.

ICM.

Okay.

I could see them.

Go back here. So…

Susan, are you able to shift screens? Maybe see it on a different… yeah, okay, great. Thank you.

Okay. Good. So, some of the things that have enabled Harmon Reliance for IMDRF are… they're providing guidance as guidelines, and then informational documents. You'll find a lot of this stuff on imdrf.org. They're also creating different principles, guidelines, and best practices through their working groups. And some of the interesting work that's going on is, for example, pre, Predetermined change control for software, for example. And they're also supporting, Their initiatives and harmonization convergence through their management committee meetings that they have, and also regional harmonization initiatives, which you'll also find on their website.

So what's IMDRF Reliance? Does anybody want to shout out and say what it is? No, I guess it's a Friday.

I'm never going to be quick enough on the mute button. It is my nemesis trying to get down and actually toggle on and off, so, so yeah, I'm probably there with you, but I'm just a bit slow. But, no, please carry on.

Okay. That's okay, did you want to put it together? I now gave the answer, but .

Whoa!

What is it for you?

Exactly, it's actually you've got on screen, and it's, it's… it's really showing its worth at the moment, but I'm sure you're going to go on to talk about that.

Yeah, I will. And actually, when I started to learn about this, I actually always thought it was just pre, you know, pre-market. And it actually… it has an… it's applicable also pre- and post-market, so I will come up with used examples that we can use and apply. So, it's basically just to summarize, it's a regulatory authority in one jurisdiction, basically accounting for and taking into consideration assessments done by another national regulatory authority, and it's a trusted institution, or trusted institution. And to reach their own decision in the end. So… Yep. So in order to support and enable reliance, there's different things that are actually

have to be considered. So, IMDRF, as I mentioned a few things before, they have guidance to support Reliance. They also… the Rye Alliance model is based on the World Health Organization practices. There's also regional reliance models as well, Harmonized Standards, you know, ESO. has harmonized their standards also to the MDR framework. There's transparency in decision making. So some of the enables… enablers… sorry, I have to go back too fast on the… Is that there's trust, there needs to be trust between the national regulatory associations, in order to enable reliance. And a few of the other points here. There's also, enables our all-strengthening relationship between the stakeholders, not go on…

Into some of these topics.

What does this mean in real terms? You know? I mean.

Yep.

go back. Like, enablers. Okay, you're, like, trust. What is that, what is… what is… how does that work, you know? Like. Tell me. I don't get it. You know, like, okay. You know?

Well, they basically…

The electric.

Can I chime in.

Yeah, sure, sure, I'd like to let you talk.

So… Having all the players in the same room together. There's discussions that are going on that you don't have when they're not in the same room. And so it's building trust and communication that hasn't existed before. And they're meeting twice a year, I believe, and they have open and closed meetings. The closed meetings are just the… I don't remember what the A stands for, because I'm used to authorities, not… You use a different term, Stephanie, for the A. national regulatory…

Authorities, yep.

Authorities. I was using authority.

frankly.

You were saying something other than authority.

Yeah, I was nervous.

Oh, okay, sorry. That's okay.

I'm showing a little bit of my nervousness. No, it's National Laboratory Story.

Don't worry about it. That's a helpful explanation, is getting everybody together, getting.

Yeah.

Getting them speaking to each other.

Yeah, I got it. Okay. And the other thing I should point out, which was also really interesting, I've attended a number of these IMDRF meetings, is.

is finding out that they don't just talk at the official IMDRF meeting, which is two times a year, which Leonard said. They also talk with each other between those meetings. So, if they have, for example, an issue by the FDA, the FDA likes to call up some of the other regulatory authorities around the world and check, oh, do you also have an issue, right? But of course, in order for that to be possible, they, of course, have to have a non-disclosure agreements between them.

So we have to keep that in consideration.

When you have an incident with your medical device in one district, that you cannot exclude the fact that they might talk to each other, and it seems And my interpretation is, when I've gone to these IMDRF meetings, is the talk between regulatory authorities has increased. From what it was 10, 15 years ago. So, please consider that when you go forward, yeah? So, it might be good to consider not just reporting to one, to talk to maybe another one that… another regulatory, or making a notice, or making communication to another regulatory authority in a market that is for you critical, you might need to consider, that in the whole equation, because they're talking more to each other.

Somebody asked how they can join these twice-a-year meetings. Are they open to the…

Yeah, half… well, what is it? The first 2 days of the 5 days is open… open to… I wouldn't say the public, it's open to regulatory professionals that they consider, I don't know, within their definition of who can attend. So, every time I've gone, I've had to submit, and most of the time I've also had to state why I should be able to attend. So, the meetings in Washington, I had to say why. Also the meeting in the U… in Berlin. I also had to say why I should attend. This… the one that's coming up in, Singapore in March. I wasn't asked, but… but I guess they do go through a filtering process, because you… you can't assume automatically you can get in. You… they go through approval process. I don't know what the process is, I…

There's thoughts.

They don't have enough.

Face limitations, too.

Yeah, yeah, as well, yeah.

Join early, join often. Okay.

Yeah. But you'll see it on the… on the IMDRF homepage, actually.

Okay.

For this next meeting, yeah? Okay. Did anybody want to talk?

No, move forward. Sorry.

Okay, good.

Value.

Okay. So, there's actually more than one reliance model, and it depends on the country, on how far they go on the country relationships, right? So, as you… As you have more level of confidence, the national regulatory authorities have more level of confidence between them. Then, they have even more recognition, or more acknowledgement, or more trust in accepting what the regulatory decision was of the other national regulatory authority. And, of course, where you have an increased level of confidence, you also have an increase in regulatory efficiency. So I summarized, these different reliance models according to the IMDRF definition. The World Health Organization has a little bit of a different separation on these.

And so the IMDRF groups them according to the bridge review, so you use another assessment in your decision-making on whether or not the product can come to market. It goes next to the work sharing, in which the two national regulatory authorities talk with each other to complete regulatory tasks, up to the, sort of, what you could call the full model, where there's a full recognition. And I can sh- and I can show you some of these, different situations. In which they really accept the regulatory decision of the National Regulatory Authority Trust Institution. And they use similar requirements or standards.

And so, it can be a uni model, where it's only one you know, trusts, or it can be bilateral, so it can be more than, you know, two, or it can be multilateral. It can be many different NRAs together. So… So, as I said, it's applicable for pre-market as well as post-market, and I just sort of summarize it here. So, for registration authorization, I noted it before, so for the NRAs, it's really knowledge sharing. They can reuse their resources more efficiently, because they can you know, share the same task with two different NRIs together to come to a decision. Increases also the transparency in the decision making. And for, of course, for the device industry, it speeds up the market access for the medical device. It's, of course, also of a benefit for the patient as well.

So, in terms of post-market, there's different elements that could be considered under Reliance. The PMS, the QMS, clinical, or change management. And I'll just, look… I'll just… briefly touch on the PMS, and here, it's really, of benefit, because through the fact that they have standardized the coding for adverse events. It allows NRAs, as well as the device industry, in case they have an automatic IT system that tracks incidents and codes. It allows them to actually identify problems early, before they occur. And also allows them to do trend analysis and reporting as well, according to the regulatory requirements.

For the Q&A.

Where would we go to do that?

Sorry, I didn't hear you.

Where would we go to do that?

Where would you go to do that?

How do you do that?

How… well, you would… you basically would… in the… in the EU, you have to have a post-market surveillance system. You have to have a vigilance system. So, you have to collect all this information about your medical device, and the way that the IMDRF has set it up is they've enabled this whole tracking to be automated. Through the fact that they've defined codes for these different incidences, so that you can sort of track what's going on. But then, of course, the NRAs also have a tracking system, so what was really interesting last… last year was, SwissMedic, so the NRA of Switzerland. Showed, you know.

briefly sort of a high-level view of their vigilance system, which they also use the IMDRF coding to track some of these things and do the vigilance reporting. And they were reporting how much quicker they could identify problems coming up and stuff. And so they're actively doing it, and have publicized that they're doing it. There's other regulatory authorities that are also using this coding to quickly identify problems, or even, you know, with the coding, they're able to talk with each other a lot better now.

You know?

Because you can identify how the relationship is, and what exactly the problem is, and you can talk sort of as common language through that coding that the IMDRF has actually specified.

I'm gonna venture a wild guess that the U.S. is not using IMDRF.

IMDRF can be… the codes themselves are used, like in the UMED database when people are filing, complaint issues. And then in the United States, there's some leveraging of codes that can happen, but there are U.S. codes, U.S.-specific codes that are used as part of your post-market safety reporting.

I use them, too, in the CER reports. You can use them as well in.

Exactly.

Sorry.

Thank you.

So, yeah, that's a really good point. So, you can really summarize your data really well from different perspectives.

Very helpful.

Okay. So, in general, through these initiatives, the process efficiency has increased. There is a reduction in duplicacy, cost, and resource savings. Also there's, the benefits of convergence of regulatory frameworks through what the IMDRF is doing. It enables trust and harmonization. And basically, it sort of globalizes the whole regulatory infrastructure in certain ways. And I, as I mentioned before, there's the pre-market and the post-market. So, pre-market faster access, post-market, quicker identification of potential problems, the MDSAP for audits.

And the other benefit of using international standards, IMDRF technical documents. So, let's go into an example. Here we have Malaysia and the United States. And in October of last year, there was a news article that, Malaysia now recognizes the, market axis of medical device in the United States. What does that mean for medical device manufacturing in the United States? It means that the assessment of their file is not done two times. So, when the Malaysian authorities get the technical file documents, they acknowledge that the FDA has looked at it.

You still have to register, but the whole process should be shortened. So, that's a benefit, one of the benefits. Here's another example in which Reliance is being used in Australia. They have another sort of reliance model in which, each country has to fulfill certain criteria. And so, I listed some of their criteria down below on the slide. And so, if you fulfill that core framework, the comparable oversized regulatory. a regulator. If you have a comparable regulatory framework, if you're an IMDRF member, if you have a life cycle to your medical device, you have vigilance, you have communication cooperation, and you have the expertise of a national

regulatory authority, then you can become a part of the core framework, but it requires political, and regulatory acceptance. So how did it develop over time, the Australian framework? It started already in 2018, With, the core members. And then, has been expanded. Over the last few years. So here's just an example of, for Australia, the TGA. what do you have to bring, for example, for Class 3 medical device, to fall into the reg… for it to be expediated? If you bring a medical device from, that has Health Canada, the MDSAP, or a medical device license of 4,

And then there's some other examples of the EUMDR. What you need to bring? What does that mean? Here's two cases in which, there was a medical device, Class 2B, that was submitted to Australia, a skin contouring radio frequency system. And there was only 32 working days from registration to mark access. And what does that really mean? Well, if you didn't have… these, documents of a 510K or MDSAP or a Reliance, or you couldn't use a Reliance, you'd be looking at 3 to 4 times as much time to get your medical device into market if it was a skin contouring radio frequency system. Then there was another example that the TGA presented at the IMDRF, and that was a mitral valve clip.

That's for the heart, right? And there again, they had only 20 working days from the registration to marking access, taking into consideration even some of the deficiencies that were issued. So really, it, reduced the time to a third, to a fourth. bringing that medical device to market. So, real substantial savings, and of course, more revenue on the year. Now, I'm just gonna go to, Argentina. They also, even though they're an official observer. They also look… look and use Reliance for their market. And so if you… they accept free sales certificates from these different countries. And if the product

Meets their technical requirements, there's no extra test or clinical trial, and there's no manufacturing site inspection required. And they've also accepted the MDSAP's audits report since 2020. And they rely on NRAs, with Argentinian alignment in terms of legislation, monitoring, compliance with international guidelines. And products in which Argentina has experience and knowledge on use and market experience. So, here's some examples of use cases, similar to what I sort of sent presented for Australia. Here, the market acts as about half of that of what you would be required if you didn't use Reliance.

Again, you have a cost saving for these different products, you know, for example, the dermal filler. You have 54 working days where you might have to have 120 working days to wait till you got market access. A reusable instrument set with a MDSAP audit report that was accepted. It had only 33 working days until it was allowed to be on the market. I'm just gonna go sort of into the… the post-market situation. Here in Brazil, they also have Reliance Implementation. And they clearly state in Sapro, Japan, that, if you have an MDSAP, and you submit your medical device to Brazil, and it's accepted, they will not come and audit your site. They will not do an on-site audit. And you're allowed to have 4 free years in which they're not going to come on-site and not audit, which really means cost savings, because…

If you have regulatory people coming onto your site, we all know this, you sort of… drive your manufacturing a bit down, you know, you're not at the top performance, high level, right? Because you're sort of making sure that everything is… the T's are crossed, and the X's are in the checkbox, right? So, so from an industry perspective, just to sort of summarize, so this quick, quicker, less costly time to market. For these devices, there's streamlining of submissions, global supply systems are predictable and timely, there's a lowering of audit burden, you're reducing jurisdiction, you're reducing these specific requirements that you see in different regions.

You're enabling convergence for regulation, guidelines, and guidances, and there's an efficient use of resources, not just on the manufacturing side, also on the NRA side, going forward. So, now I'm just going to say, okay, how's Reliance going to be used in the future? Well, this is what's… was communicated, the TGA, Australia. They're looking at Reliance discussions with the UK. And also Brazil? The UK is working with Japan. for, medical device approvals. Swiss Medic. is as of last year, they are, one of the management, committee members, and they're improving their PMS, so the post-market and vigilance, surveillance, as I discussed before.

And they're using… digital AI technologies to do that. So they've been able to, reduce the amount of effort that is required to start mapping what's going on. And even Argentina, which is an official observer, had put out their strategic plan, that they're streamlining processes and convergence and reliance practices going forward. And what's going to be coming is a publication, the IMDRF Reliance Playbook, where they outline the different methods of reliance going forward, and how they see reliance. And the IMDRF, and as well as the EU, have, stated that they're going to be, identifying NRAs, and how, Reliance is implementing

So there's more transparency on who is using what reliance model. So it assists, of course, manufacturers and the other stakeholders that are interested in bringing medical devices to market to understand what is really required to bring a medical device to market. And how, post-market, what are the benefits, or what will be, acknowledged? As useful in terms of reducing audit burden? And… And… What… what happened with the EU MDR proposal, the revision proposal? I was actually really happy because I submitted my comments to the survey for the MDR, and I stated one of the things they should do is really harmonize the regulations of the IMDRF.

You know, to have more of a global approach. And if you look at the MDR, the text that we now have, not the revised text, they have it mentioned in the preamble, but they don't have it in the regulation itself. So what's really interesting is that the EU MDR revision proposal now contains two new articles. And they're taking into consideration the IMDRF, and they're taking into consideration the medical device single audit program, and that's another reason why I thought I'd bring this topic up today, is because anybody who's involved in the EU market, can really maybe take advantage of this going forward, because…

They are now acknowledging that the IMDRF has some significance, and also the MDSAP program, one of the initiatives of the IMDRF, So this is Article 108, this is a snapshot of it. It's not the complete one version. There's another point to that, but I just wanted to make it visible. And what's interesting as well is in Article 108B, is they now talk about reliance. So, I'm hopeful that, we will have a speeder time to market for medical devices that have market access in other countries. As we go forward. And so, it was really interesting, the last IMDRF merit meetings where the E was participating, and

I had heard early… when the meetings were in the United States, I heard early in those meetings, and also in Berlin, that it was politically, they were not really… so gung-ho with the IMDRF and the initiatives, but obviously. the IMDRF, if this proposal goes through as it is, or as it has been proposed, I think the IMDRF And its initiatives of harmonization and convergence will become more prominent. because the EU MDR has now acknowledged the importance of The work that they're doing. So…

So we did something fun.

Oop, I just want to go. Hold on, I just have one more slide. And so, just to continue, they enable reliance, bringing regulatories together. NRAs together, through their meetings, and also online. They also have online meetings, but they don't publish… I mean, they're not very open to the public to tell you that they're doing it, and when they're doing it, so… but they have acknowledged that they do it. They're building trust. They're sharing their experiences, they're driving convergence regulation. They're converging the technical documentation, the requirements, and, as well, the last point, which I didn't mention in the presentation, they're also providing training. So the vigilance and the adverse event coding, they also provide training on those, and more information could be found, actually, on the IMDRF site.

Okay, and there, I'm finished, Sean, and take it over to you.

Thank you very much. So, we did something fun where, and this is something that I want to start trying to do every week, is that when I meet with the speaker, I say, you know, so what's in it for the people on the call? Like, how does this help them, right? And so what we did was we created, I put it in the chat, I think you can see it, let me know if you can't see it. It's a Word document, and you say, this is my device, this is what kind of company I work for, this is what stage we're at, this is… all the information, the risk class, all that stuff, you just type that into the Word document, then you take the whole Word document and you drop it directly into ChatGPT or Claude.

And it basically tells you what the benefit of IMDRF is to you, how it's going to help you, and where you could see, More rapid market expansion, where you could see more efficiencies in post-market surveillance, where, you can benefit the most depending on what stage your product's at. I thought it was a fun, cool tool. Basically. What we want to do is we want to say, okay, let's take the information that we gathered today, and then… take that to AI. And then say, now what can I do with that? So, Carrie, you know, you have a product, and you want to say, hey, I'm just curious, you know, what's it going to do for this product? You know, fill in the information, give it any other information you feel like giving it, you know? And the more detail that

the LLMs have, the better the answer they're gonna give you. So, feel free to, you know, cut and paste stuff into it. I would caution that you don't want to use proprietary. Information, if you're not using the paid model of, of ChatGPT, or… or Claude, and you want to make sure that you have not training, The algorithm or the system, switched off so that you're not or on, whatever, you know, sharing any proprietary information. But if you do that, you get, a fairly interesting answer. So I had filled one out. I'm gonna try to share my screen, hopefully I won't screw this up, and go to chat, and say.

This, I put in, you know, some basic information. And it says, here's a clean one. So, I'm the manufacturer, I have an implantable cardiac device, it's, EUMDR Class 3. It's a marketed product. I have, FDA, PMA, and Health Canada approval, and my priority expansion is Asia and European Union. Primary constraint today is time to approval. But you can pick any of the other ones, and then it basically gives me a business-focused interpretation of You know, redundant audits, variations in similar QMS elements, resource strain, And…

it works through this thing, and then it, of course, asks you more questions at the end, like, you know, do you want to do this? So as a starting point, taking the information from these calls, putting it into, what does that mean for me? what does that mean for my device? What does… how can I use… the information that we crowdsource together here every week to help me further my career. Isn't that fun? Thoughts, comments?

Find my screen. Yikes. Sorry, stop share. There we go. Back. Yeah, so Stephanie and I put that together yesterday, 2… Help. You… Leo, you had your hand raised.

Yes, so I was… Gonna go for a cold, so I'm a little scratchy. Excuse me. So, with the EUMDR, And the concept that they're talking about, which would be great, because that would move things along, hopefully. The one aspect that I thought about that I think would be a… Friction point would be the clinical review aspect still, I suspect, because MDSAP doesn't… That's the quality system aspect. That doesn't cover the review, right? From what I understand, I'm not very clear on MDSAP, the full extent of it, because I've never done a full audit.

Well, it's… reliance is also… it's not just restricted to the quality management. I mean, from… MVSAP is really, it's ESO 13485 plus the regulatory requirements in addition. And so, Reliance is not just MDSAP or, Quality Management System Review. Reliance is also acknowledging and accepting as I said, varying degrees of the regulatory framework of another national regulatory authority. And the reason I'm so optimistic is because, I'm just gonna go back here, if I can… The reason I'm so optimistic is because, if you take a look at this, it's, it's, not just acknowledging MDSAP. MDSAP, they've listed as a separate,

entity, they're also acknowledging regulatory frameworks of other. I'm… I'm… my assumption, my interpretation is that they'll acknowledge and accept Either fully or partially regulatory requirements of other countries and other regions. As well as the post-market regulatory requirements of other countries and regions. But at the end of the day, we all know that what is written in regulation, what is then, in the end, implemented by the regulatory authorities is not always one-to-one. As we see with the MDCG documents, for example, it's not one-to-one with the regulation, but I… I'm very hopeful

that we will have a quicker time to market using other market releases in other countries in the EU, in that the fact that they're recognizing the IMDRF and the initiatives. And one point I forgot to mention was, is that they also, through their working groups, they're also involved in, helping out the whole design and the development of medical devices, for example, that for, software, or medical devices with AE, so it's not just It's not just, you know, pre-market, submissions and post-market vigilance adverse events. It's also… they're also, trying to get harmonization on the product development side as well.

Through their different working groups.

I hope that answers your question.

Thank you.

Martin?

Yeah, I think, picking up on Leo's point, I think the… Every sac piece is important, because it… having been on the being audited side of MDSAT, it really is looking at the efficacy of your QMS, Specific to the land requirements.

Yeah.

So it's not enough to have 13485, and that's why the FDA actually says that for manufacturer oversight. They need to see that you can meet the QMS requirements of 13485 as if it's implemented in the market where you want to go. And then… and that's really important, because the QMS is the policing or governing part of the regulation. It's how a company governs the implementation of a regulation. So this whole reliance thing, it has different parts, and it's really important. But I think we have to be realistic that Things like usability. Clinical evaluation, there are always going to be regional-specific aspects to that that you're going to have to fulfill.

So the idea that you have a technical file, and your whole submission is one set of files, and you did all your studies in the US, and it's good for the whole world, that's just not a realistic proposal. But that you have one set of documents, and that you replace certain elements of those documents specific for the region that you want to go to. That is a realistic goal that we can reach, and I think we're going to reach it quicker. than… than I previously thought it was going to take 10 years. I think it's going to take less.

I… but Martin, I would like to make one point very clear. I am on the other standing, with Australia TGA, for example. They do recognize the clinical data and the clinical studies, because they wouldn't be at a quarter of the time for market release. You wouldn't be looking at 33 days for a Class 3 medical device if you didn't recognize or acknowledge the clinical data, and that's what I had understood when I attended the IMDRF meetings. So, as I said. It doesn't say to the extent that they will trust the data. I agree with you for the MDR revision. But it doesn't exclude the possibility that they might be pushed against the wall to such an extent that they might be going, you know, the Australian TGA method, because we do have a substantial reduction

in medical product availability, it's not transparent. It's only transparent if you go to the doctor, and he starts to tell you about all the medical devices he doesn't have for special patient groups, which I always get from every single doctor I've been visiting the last 2 years. Because I know where I'm… what areas I'm working in. And so… I'm hopeful. I've never been so hopeful as I am when I read this, because this is one thing I submitted, and I said, hey guys, let's do some international harmonization here. And I also said, well, why do we, you know, why do we need our own coding? I mean, that's another point, you know? Anyways, why don't we use the GMDN codes, right?

So, yeah, I agree, clinicalism, always a difficulty, because you and I probably… We both know that, for example, if you go to Germany, every single little region in Germany has their little specific requirement, regulatory requirements, right? But… Maybe, maybe EU will be pushed so much against the wall that things will have to drop fast. And things will have to be accepted, so that not more doctors leave the EU and go to other countries, like Canada.

I know of doctors who've left because they don't get their innovative devices.

Here in ye you, or the considering.

That's disturbing. Edwin, you had a question?

Yeah, I, was that one to ask about the GHTF guidance documents, that at the IMDRF meetings in the U.S, they reported there were 4 of them that were going to be revised. They were the risk guidance. the purchasing guidance, the Kappa guidance. And, now I forget what the fourth one was. But anyway, they were assigned to the quality group, which was to be headed up by Melissa Torres from the FDA, who has since left the FDA. But there's no progress reports that I've seen on any of those. Now, to me, those are important because

the Risk Management Guidance Document… no, the CAPA Guidance Document. The CAPA guidance Document was the input to ISO 1345, Clause 8, and ISO 14971, Clause 10, when we developed those two standards. So, they were built around that IMDRF guidance, and… and, those were… Basically, almost out of date. At that point, but they needed updating. And, so these guidance documents have been useful in developing standards and other work, and needed the update, but we've not heard anything about it. It went through the whole Japan thing last year, and I never heard anything then.

When Japan was the secretary.

Yeah… I got a chance to talk to her, but I didn't talk to her specifically about those documents. What I do know, behind the scenes. is, When we were in Tokyo, the FDA members, were not allowed to attend the meeting in Tokyo. So, we didn't see them. I mean, at least I didn't see them for the first two days. I was told after, the first two days that they did some webinars with the other NRAs. In SAPRO, the FDA, wasn't in attendance. I think there were 3 or 4 of them. And… Basically. I mean, this is not a direct quote, it's my interpretation. There was not a lot of support for the IMDRF initiatives.

And they were getting pushback, and so I… In some cases, they had to fund some of their own travel. But, I mean, I… I think… I think, I think it's more of a political situation. that might be preventing things from going forward. But there was not an official position. on that, it… I'm just talking about, you know, conversations.

Well, the membership.

Personal conversations.

Yeah, the membership of the quality subcommittee from IMDRF was handling that. If Melissa left. And nothing happened. there's still other members of that group, and I'm wondering if they had any progress on… on doing those, because there were 4 really important guidance documents in there. From a quality perspective that needed updating. Think process validation was… One of those, too.

Yeah. Well, I guess you might get an update, then, in… from Singapore? on the meeting of Singapore, With regards to that?

Christine had a comment or question.

Hi, two things. One, I just wondered, what, what was the weight of the WHO in these conversations at IMDRF? Are they viewed… with the same level of impact as a national authority, or do they have less, like, as kind of like a non-voting member? I don't remember what their status is, but I also wondered how they're being viewed in the meetings versus the, the actual authorities.

They are participating in the meeting, they're giving reports in the meetings, they are an official observer, and the reliance model, the IMDRF, actually reference back to the World Health Organization's reliance model, so they do play an active role, so… but they're seen as… and also. Classified as an official observer. So…

I also had a comment just on the topic of clinical that we were discussing. It was interesting to hear everybody's comments. you know, From what I've seen. at the end of the day, it's all about clinical… it's sort of assessing clinical risk, right? So when you look at what TGA is doing, and the way they're making decisions on what evidence they require to get into their market. You know, how disassociated is that from MDSAP, right? So I took MDSAP training a number of years ago, and I've done a few audits, and You know, the concept, of course, is that you not only apply 1345, but whatever the regulatory scheme is for that market, right?

And so, you know, I think this is putting pressure on Europe to say, okay, well, you know, what's happening in Australia with events for devices they've let in quickly? Right? Versus the European model that they've been using under MDR that obviously is going to be… have to be reformed. And so, you know, that's… that… at the end of the day, it comes down to that. How are you looking at risk, and how are you assessing clinical risk? So I just… I just wanted to bring that back up, because I… I was really enjoying the discussion.

Thank you.

Yeah, I think it's important points that you raise, like the others.

Carrie.

Yeah, I was just gonna say, from a clinical perspective, the reliance really starts with the IMDRF. It's where regulatory regulators align on how the clinical evidence is generated, evaluated, and interpreted across the whole product life cycle. And when your clinical strategy is built on the IDM of our principles, regulators can really rely on each other's assessments much more… with much more confidence, and That's what allows the MedSapp to work operationally with real-world evidence to extend the clinical story post-market, and you're not recreating clinical justifications in every jurisdiction. You're building it on shared, trusted clinical foundations.

That's all. In my opinion.

I had an interesting discussion with a notified body, one time off the record, and they said to me, If the FDA has reviewed the clinical evidence and found it to be acceptable, I'm gonna give a lot of weight to that decision in my decision-making process in the EU. You know, I mean…

Because I've played a lot with the real-world evidence and got clearances in the U.S, and vice versa in the EU, so… And then that clinical justification, Works for real-world evidence going to multiple jurisdictions, so… You know, I have a client where they're now in 69 other countries based on those foundations of real-world evidence.

I think you bring up something really important, Carrie. There's a lot of really great documents and supporting guidelines and stuff on the clinical area under the IMDRF, which is really worth a read, and that's something… that's an important point that you bring up there.

And, you know, it works for… I mean, a lot of these… products that we're bringing to market, you have to remember they're being used with Patients, it's a patient, and they're being used with drugs in combination as well, and so it's just… use your real-world clinical evidence, and you can… it's a… huge foundation, irregardless to what… where the patients are. You can use it for your FDA clearance, you can use it for your EU foundation, you can use it wherever it's being used. I use Singapore evidence all the time for FDA clearances, for example.

And that's also… I mean, I'm really happy that they're using that data now, because a clinical study is usually set up so perfectly, right? You have a perfect patient population, you have no people with, like, multiple comorbidities, and you just make sure everything's perfect, and They're, you know, young and, I don't know, 20, 30, so I find it fantastic that they're now using real-world Real-world evidence, sorry. Because you're taking out those special cases, right? You also have, you know, you have those people that just might not be able to handle that medical device, right? Correct. And so I think it's excellent that they can pull data from, you know, insurance companies, or registers, or

you name it. I mean, there's so many different sources. And what's also cool about the IMDRF, one thing I didn't mention, was they also have all the links to the vigilant databases of the authorities available, so you can also go through all that data. And you can come up with really interesting observations, and even maybe possible product ideas, right? From seeing what did not work at different countries. So, yeah, great point.

Nope.

So, we're about out of time, well, we are out of time, but Tracy had a question, or a comment or something, and so I wanted to give Tracy the final word before we sign off. Tracy?

I've… yeah, I almost wish you hadn't gone to me now, Mark, because, I was… I love all this positivity. However. Most people in the medical device are not in the IVD, area, and I'm… my experience in the IVD, space, particularly having gone through a huge amount of, transition, approvals for IVDR, and finding that, that, you know, data sets, generated in the rest of the world, where, you know, data from the WHO evaluations, for example, was not sufficient, and that, you know, the EU,

notified bodies obviously have been and will continue to hold firm to, to what sits in MDCG guidances or specifications, commence investigations and stuff, so… I mean, I've been a little bit away this last year, so I wonder whether if the tide is turning, I don't expect. In terms of the proposal that the EU's just recently put out for Christmas, yeah, I mean, the sound bites were that that may come through in… in… quickest, you know, the next year, for example, I cannot see that happening. at all. Because unfortunately the, you know, the scale of the union and the different… the amount of voices there, it's… you know, I think the… the people that I'm talking to are saying, hmm, yeah, okay, we're talking years, right, before actually they agree, let alone actually then get to a point of implementing anything. I think on a… my only positive thing is the work that the UK are…

doing, in the reliance space, and maybe that, you know, and also the… the work that's happening in Africa, which obviously is based on, the CDC is kind of adopting, you know, as expected, what's come from the WHO and from IMDRF, and we're waiting to see what happens in April. So, you know, I… I… there is, for me, a little bit of positivity. I am an absolute, kind of, fan of this, it is difficult for manufacturers to actually go through an MDSAP audit. It does cost a lot of money, it takes a lot of time, and the more countries you introduce, the more complex it's going to get. I think it's going to be a hard sell, to CEOs, potentially, because the upfront cost will be quite significant, the work will be quite large. But, I am a… I am an advocate, but if anyone else has got any,

stories of positivity in the IBD area, then please send me, because I could deal with some. It's, yeah, it's difficult, especially as I deal a lot with global health products, so I'm not dealing with you know, kind of stringent authority to, you know, and taking that across to, to another jurisdiction, we're looking more at direct access, which is incredibly difficult. So, yeah. Anyway, sorry, Sean, I know you want to close.

No, I'm… I… I thank you for your comments, and you know… IVD is, I was talking about that earlier this morning with somebody, and it's its own… its own special entity in a lot of ways, and certainly has its own… restrictions. I think to end on a positive note, we can say that, IMDRF has certainly taken on a challenging, thing, and is moving in the right direction, and as Martin said, we might see it sooner. Rather than later. Ivds might be last in line, I don't know, but, they, Yeah. So, I will send the,

the document, anybody who, is unable to download the thing, and if you, drop your email address in there, I can, I can phish your email address out of the system. You don't need to worry about that. Just tell me that you can't download it, and, and I'll… send it… send it along. Thanks everybody for your comments, for your participation, especially thank you to Stephanie Grassman, for speaking today. Thank you, Stephanie, and very, very, very insightful. Next week, we're gonna have, Jose Barquequez talking about favorite… everyone's favorite topic, cybersecurity, and, I… I look forward to a lively discussion. We got some other, people lined up, but if you would like to speak, please, do let me know, and, we'll see if we can work on a topic together. And,

I look forward to a exciting year. Thanks, everyone.

Thank you very much, Sean. Can I just say one thing? 2027, Tracy. I was told by two different people that work with the MDR implementation. They know me in Brussels, and they were saying 2026, impossible, but possibly 2027. But my personal opinion is, is if their back is against the wall and they get so much pressure. We're gonna see it sooner than later. So, I'm optimistic. I don't think 2026 is realistic. I've been told that by more than one of them. There's, I guess, 8 of them that are involved in implementation. I know the majority, and they were just talking about 2027, 2028, so there you go.

Definitely in the past.

Sean.

Yeah, but Stephanie, we need to catch up, and I'll… I'll email you.

Thank you, yeah, looking forward to it. Thank you very much for all your participation, I really appreciate the conversation.

Thank you, Stephanie, thank you so much.

Thanks, everybody.

Yeah, everyone, see you next week.

Bye!

I… okay.