Definitive MDSAP Program Update: Strategies for Global Compliance & Market Success

Oh, and good morning. Good afternoon. Good evening depending on where you're calling from. Welcome to the definitive Md set program. Update strategies for global global compliance and market success with Brian Ludovico from Alamed consulting and Sebastiano Poni from to Rhineland. I'm so excited to have these 2 join Us. Med tech leading voice today because they know a lot about the Mds app program. They've been intimately involved with the program for a while. Tell us a little bit about your background, Brian. Let's start with you. Where are where are you calling in from.

Well, I'm I'm actually located in Connecticut. So.

And your background with empty shop goes back a waves.

Quite a ways. Actually, I started with the the notified body. A a autoing organization a long time ago, and I became familiar with Mds app. Working with the governmental regulators from the individual jurisdictions at the very beginning of the program. And was fortunate enough to work with a lot of very smart people to implement the procedures and the program requirements. Throughout more than more than one company.

That's awesome. And, Sebastiano you're joining from Rome.

I'm joining from Rome, but working for our Cologne office. And yeah, I'm in the Md sub program since the beginning, basically from 2,018, first as a Auditor and certification Office, and then 3 years ago, I took the role of global scheme manager for to freelance. So before I take care of implementing the program within our auditing organization, and get in touch with the old regulatory authorities from the end. This up program and sitting in the Forum to adjust or to follow the progresses in the program. Yeah.

Okay, that's awesome. And I'm for those of you don't know me, Shawn Smith, publisher of Med. Tech leading voice. I am dialing in from Constance, Germany this week. So happy to be here if everybody could just go ahead and put in the chat where they're cut, what country they're calling in from that would be awesome. Give us an idea of of who you are. We're gonna have a few poll questions. Please feel free to use the chat or the QA function throughout the thing, we're gonna try to get to your questions. But we have a lot of slides to cover today, so it might not happen. This is being recorded, and everybody who's registered will get a copy of the recording and possibly the slides. Are you sharing the slides.

Brian?

yep.

Yeah, great fantastic. So let's get started. Thanks. Lots of people calling in from all over.

Great fantastic. Well, thank you very much, Shawn. It's pleasure to be here. Welcome everybody from wherever you are. I'd like to initiate and thanks to my colleague Sebastiano for joining as well, it was nice to get together with him. Sebastiano and I have known each other for quite some time, and and we'd like to bring you as much as we can on Mds, as a as a global program. So go over the agenda first. We've got some another little bit. Speaker introductions. A little bit about our organizations and we'll go through what you see on the screen here, as far as the Mds. App itself. The structure a little bit about the audit. Approach. what we feel is a hot topic, of course, of is the European Union situation, as we call it, and moving into some program statistics. And Sebastiano has been nice enough to bring out some

actual auditing and program requirements and challenges that we see. QA. At the end is, Shawn said. If we can possibly get to that. And then, of course, you know, contacting us for further information. So a little again, a little bit about myself. I am the Director of Quality Affairs at Alamed. I have been in the regulatory and quality business for over 25 years. I can't believe I can say that out loud now. I am a former notified body and auditing organization regulator. I actually worked for TV, Rhineland for 21 years where I cut my teeth on not only the notified body, but the auditing organization itself.

and participated in the development implementation of Mds. With the jurisdictional representatives, as I mentioned before. I will let Sebastian. I'll also introduce himself.

Yes, as thank you, Brian, as I just mentioned before, I'm currently the Md. Sub scheme manager for to freelance sitting in Cologne office. And I have more than 20 years experience in basically auditing of which for for the Italian competent authorities, or auditing on behalf of the corporate authorities and 18 in to Fryland. I'm currently both working as a certification Office under the notified body Mdr. And for the auditing organization. And I'm still doing some operational things like auditing and certification technical documentation. review. That's why I wanna to bring today also a little bit of approach of the Mds, but also looking at the companies and with the notified bodies activities. Yeah.

thank you.

One. Thank you little bit about our organizations. Alamed. We are a consulting organization leader in the medical device area. Having a number of different competency areas, including quality assurance and quality system development regulatory approvals, clinical and we have a team of experts that we work with across all areas of the globe I have been with alamed now since August. I'm very pleased to be here. It's my it's my first time into the consulting world after working in so many different parts of the industry. And it's it's it's coming along just nicely. And for TV, Ryan Sebastiano. You can explain maybe a little bit about

the differences very quickly about the different types of organizations within the umbrella of TV.

Yes, so to to Fryland. In general, as a organization is a company that provides the services for the industry. And the medical group specifically within 2, for Rylanda holds several notification or accreditation. So a and the different companies together worldwide holds different accreditation or accredit, notification. So the German location. So T. 2 Freelan products is the notified body under Mdr. Ivr. As well as under En Iso. 1345, under Dax, which is the German accreditation, while the 2 Freelan of North America is the Ao. Is the auditing organization recognized under Mds app

by 2 frail, and the Uk is the Uk approved body. This just to tell about the the main accreditation. There are several others available in the various locations. Yeah.

And this is particularly important for you, the audience, because later on you'll see that there are some legalities that are involved with the notified body and the auditing organizations with respect to how audits are conducted, how technical documentation is reviewed. So it's important to know the players, even within a certain organization and how they hold the different accreditations, and what that means? It will hopefully become apparent. So what is Mds Mds app is a program obviously with the objective to manage, oversee and develop a single audit. Okay, that will allow a medical device manufacturer to have the needs fulfilled in several or multiple

regulatory jurisdictions. So obviously way back. When when this was developed, it was a it was the the information was, to be able to get a single manufacturer to be able to get into multiple markets not only quicker, but also at the same time. So in the world of changing regulatory it was, how can we leverage different things? How can we move forward? Obviously, at that time the European Union structure had been out there with 27 different countries, and this sort of Ce marking passport across the different barriers, and and and other parts of the world. taking a look at how they would leverage different capacities, especially when it comes to

countries that didn't have their own regulatory. Those countries we're looking to, you know, sort of speak borrow a way that maybe they could use a a a jurisdictions, approval for their own area instead of reinventing the wheel day. The mission of this international consortium is to pool the technologies and leveraging resources, as I mentioned resources is obviously, in all all companies, very important, and services to manage a sustainable single audit program for improving the oversight of safety and efficacy on a on a large scale, on an international scale. This is this is an international partnership. I wanted to make sure that everybody understands that this is not something that was

solely developed by only the FDA, or it is just one country. It is a. It is a partnership amongst 5 jurisdictions in which all of the information was shared and agreed upon. At the present time the FDA's website does house most of the information of the program. So if you go to FDA Gov, you will see you type in Mds. You will see all the information. For the Mds program. But it is, it is based on everybody's participation so equally amongst those organizations.

Brian now might be a good time to find out where the audience is. In their journey. Launching the first poll question. launch hopefully. This will.

Excellent, excellent.

You know what kind of organization they're coming from? Interesting.

Okay, that's fantastic. I see that I see our chat feature is moving up and up and up. That's fantastic. So our poll is out there. Certainly let us know we choice, seeing how many people are out there. So you can see the participating jurisdictions of Mds right now up there are 5 that are the Australia, Brazil, Canada, Japan, and the Us. Again, all participating equally. And these are the actual governmental organizations that you see on the screen for each of those representative jurisdictions. Within each of these jurisdictions the program. So the Mds program and what I'd like to make sure of is that people understand

Mds is a program. It is not an additional set of requirements. so I know that in many cases we sort of truncate our speech when we talk about things like, well, you know, did you pass your Mds audit, or you know, did you follow the Mds rules. Mds app does not add anything extra. These are all the regulations that are from those jurisdictions. Mds. Is simply a program that houses them within one area. So again, you may hear that speak from the Mds app auditing organization, or from the from the manufacturers. So in each case the program is used in a different way by the different jurisdictions, and we're going to go into each one of those now

and and take a look at how that is use. So for Australia. And Sebastiano, you could step in here anytime you'd like for Australia. The certificates are used by the sponsors for the AR tg, which is the registry of therapeutic goods the MDF. Audit report packages are used to support the certificate application and or or the changes to the application. And the outcomes are used for post market activities. in this particular case, again, the certificates are used. The support packages are the auto report. Packages are used to support the information.

But that's typically what they're looking for is the certificate that is issued in Brazil and basically utilize the reports themselves. Instead of the certificates to grant initial Gmp certifications. Sebastian, would you like to tell you a little something about that.

Yes, so, the Gmp. Certification is required to obtain a registration. So the publication on the Brazilian Gazette for the devices in class 3 and 4 so, and this app is one of the mean where Brazil can, on these, in particular, can add the can confirm the compliance of the Qms. Requirements and devices of class one and 2 per se. Do not need gmp certifications, but require, indeed, that the manufacturer have an effective Qms. But the there is no verification done that this is satisfied. Of course, if a customer, if a manufacturer wants and have already class 3 and 4 devices may also include the the class, 2 devices and one in the scope of the Mds up once it's it's needed. Yeah.

Right. So you could see the difference already between Australia and Brazil with the use of the certificate in one case, and uses of the audit reports in another. Right now we move on to Canada Canada is using MDF. As the sole mechanism to demonstrate compliance under their medical device regulations. If some of you out there may remember the camcast program that was initial to the the Canadian market. This has replaced that obviously back in 2,019 and within the regulations from Canada Canada now requires a valid 1,345 certificate issued under Mds. And you can notice here where I said 1345, issued under Mds. So again, we use the term Mds certificate. Very you know, colloquialism, but it is actually a valid 1345 certificate issued under the Mds program itself.

And this is where you see the difference between maybe a certificate that was issued for Dax or the or the the the certification body. So you can have multiple 1345 certificates at one time depending on how and which body they're issued. And at the beginning of the slides we mentioned that different organizations, different legal organizations, are accredited to issue different types of certificates. In this particular case the auditing organization would be the one responsible for issuing a 1,345 certificate under Mdsec. Not a notified body. So there's a difference there. In Canada. The certificate is required, of course, to apply for a device license which is written into their program as well

and similar to other areas class. One devices are not required in this particular case to have a certified quality management system.

Brian, allow me to step in just one important note. It's important to understand that for Canada. And this app is the only option. So if a manufacturer wants to go to have a device license issued by health, Canada as a proof that there they have a quality management system under Iso 13, 4, 85 implementing Canadian requirements. And this app is the only option. Yeah. And while for the other 4, jurisdiction is kind of optional, let's say, but for Canada is not.

Good point. Good point for Japan under the pharmaceutical Medical Devices agency the they will use the audit reports again, very similar to the way in which Brazil uses the audit reports, for as a coverage of the Qms. Requirements under their ordinance, 1 69. As far as granting product authorizations in that jurisdiction. And again, as we see class one medical devices are not required of a certified certified quality management system in the Us. The FDA will accept Mds audit reports. Many of you who have Mds will know this, of course. This program is not affecting those audits that are for cause or compliance follow up.

or those for pre-market authorization. That's a very important notification. People are always asking. you know, if I get Mds. Do I ever see the FDA again? Yes, that's not. It's not going to replace the FDA in that particular case, but it will work with their work program and there will be routine inspections that will be staved off as you will. Outcomes of the Mds app audits are, of course, analyzed. And again. in this particular area, some areas of exempt class one medical devices, as you all know, from the Qms. So the Mds app structure itself, and a lot of people may not understand the structure within Mds. But Mds. Is made up of a regulatory Authorities Council. You'll hear the name rack

here. Which is it? Basically the decision making body of Mds app. It consists of the regulatory authorities from each of those 5 jurisdictions, as we mentioned before. and they provide the oversight and the direction and and the resources to support not only the Mds app development as it was, but the continued development and possible expansion. and we'll talk a little bit more about that in a few slides with the main responsibilities being to monitor and modify the objectives, the requirements, the policies, and even the procedures. And again, if you go to the FDA Gov website and you look up Mds, you will see everything is transparent. You will see.

All of the procedures, all of the forms, all of the information. As a matter of fact. it even gives you the audit approach, which is all of the questions that you could ever be asked under the program by an external auditor of any kind, and used for your own internal audit. So when I say completely transparent, it is completely transparent. The rack also is the recognizing organization, for not only other rack members in a promotional sense. But official observers affiliate members and the auditing organizations themselves. So remember, we have notified bodies as a legal entity. We have auditing organizations under Mds app. And we also have certification bodies. These 3 act independently in some cases, but also together. In most cases. There are a certain number that, have all of the accreditation obviously to serve their clients in a in a in a better fashion.

The right. The rac, of course, has full access to what is the it portal under Mds. That is utilized, which is called the Regulatory Exchange platform or reps. And what is reps? I'm glad you asked. It is the again the It platform for the exchange of information between the auditing organizations and the rac. So that's gentle. Maybe you could step in and give a little bit more about reps and its usage. Here.

Yes, so reps is this it platform, which is mainly operated by the auditing organization so prior, or after having performed an audit. So the auditing organization, when a a manufacturer applies, will register the manufacturer to the platform, to to whom will be given an id. and then, after the the auditor all the audit evidences, the main audit evidence like audit reports, audit plan, list of devices, list of critical supplier, and so on will be uploaded into the the platform, and the audit will be closed. Then this platform is accessed by the 5 jurisdiction. Who will use the audit reports for their own regulatory needs, like Brazil, for instance.

And we success it to review the report and grant the Gmp. Certificates and and so on. So this is the tool used for exchange of of information. Yeah.

What was the website that was just mentioned.

Say again, say again.

The the website that you guys just mentioned.

It's called reps.

Oh, raps!

Reps. R. Eps. Regulatory exchange platform.

Right.

But it is not a website, and it is not accessible to the manufacturers.

Off. Understood? Yeah.

Okay, this is a. This is the exchange of information, sort of behind the scenes, if you will, between the auditing organizations and the rac, or the participating jurisdictions.

Yeah, it's important to know that when a manufacturer participate to the program, the audit record will not only given into his end, and, of course, of the auditing organization. This is going to be shared among all the jurisdictions Jeff.

Wonderful. Thank you.

Welcome. Yeah.

Okay? So we mentioned before, the structure. And an official observer. So and there's different levels within the program. So there's the rac. There's the 5 jurisdictional members the founding founding representatives, as we call it, and then there is an official observer. So the it is a regulatory authority that is not a member of the original 5 of the rack, but who observes and contributes to those activities. So this information from the official observer. Is taken into consideration. Obviously and while not having equal authority. And again, I'm not one to read. You can read this on the slides. With respect to final decisions, which is the rac

they do provide input they do provide cross check if you will or a sounding board and and alternatives to decisions and deliverables based on their information or based on what they've seen or based on what they'd like to see. Obviously, with official observers, they're trying to figure out if their this Mds program will work best for them. So they would like to add information to the program. They utilize the audit reports or the certificates for evaluated compliance of medical devices within their own regulatory framework. And these official observers do actually have access to the reporting information under the It portal again, known as reps. So it's an important distinction as an official observer

under the program. So it's sort of a if you will the Second level under the rack. An affiliate member. Okay, is a regulatory authority. Again, that is not a member of the rack or an official observer. That also is part of Mds. But does not participate in the decision making processes of Mds. App. It also utilizes audit reports and certificates for evaluating compliance, and again looking for their own regulatory framework within their own country, trying to figure out whether or not. This program works best for them, trying to ensure that something that has been already developed is something that they could utilize. As far as

compliance and and and of course, the overall goal with risk of safety and effectiveness. They do not in this particular case have access to the portal. So this is a difference between the the official observers and the affiliate member. Okay? Instead, the affiliate members are able to get a list of the Mds facilities for the manufacturers, including the dates that the audits took place. The Ao and they can obtain the reports in the statics by actually contacting the manufacturer. So so they're given the information to be able to go out and get the to be able to get the information that they need

from the manufacturer. So it's almost instead of giving permission to get into the reps database, they have to actually go to the manufacturer to get it. So again, a little bit of a level down in that respect. But this affiliate membership is growing each each and every day, and we'll we'll see that in just a second as well. So within the official observers the European Union and the WHO. Have beneficial observers from the very beginning. And they continue to be again. The European Union situation will go over a little while. Singapore is brand new Sebastiano. This this was what, as of.

Couple of days ago. Yeah, yeah, last, yeah,

So now the Singapore health sciences. Authority is an official observer, sort of, if you will, upgraded from affiliate number, which they were for quite some time, and of course the Mhra under the Uk. And we all know what's going on with the Uk. And Brexit and all that. So now we're moving into a different compliance area within the Uk. As well. and under affiliate members. You can see here. We have 6 affiliate members at the present time as as noted on the right side. So Sebastiano, anything to add here, as far as.

Yeah, all the all these affiliate members. And the last added also a few weeks ago, was Kenya have been joined under the affiliate programs in in the last couple of years. So this means that the number of countries who are looking at the end, this up is growing constantly. So it's getting more and more important as kind of international standard. The for the medical device, approval of quality management system. Yeah.

Exactly. And remember. So with with the pervasiveness of 13, 4, 85 in a global spectrum. Right? So you have this this quality management system recognized for medical device manufacturers under 1,345. And you've got that as the platform, as you will for implementation of the regulations. Remember, 1345 is not a must. It's a nice to have. but it provides the platform for building. On top of that. The regulations of each area that come in. And that's the basis of the Mdsat program. And as other countries that are outside the European Union and the FDA, which have established programs for quite some time. Now.

these other areas are now building upon that to add their regulations within that framework. So it slides very nicely into each area of that 1,345 and as the confidence of the program builds, you can see here more and more countries are looking to in, you know, use that information within their own organizations.

Why don't we go ahead and launch the second poll question, and then take take a peek at some of the questions that came in one question. That's interesting before you move on is what the advantages there to the medical device manufacturers from having affiliate members. I thought that was a particularly interesting question.

Say that again.

In the Qa. It's what what advantages there to the device. Manufacturers having affiliate members.

So the the affiliate membership the best part about that for manufacturers is to see that other areas of the world are interested in Mds. And they will be able to leverage the information that is done on an Mds. App audit or a certification depending on the jurisdictions acceptance. However, they want to accept it. Remember, as an affiliate member, they're looking at this information to say somebody else has done something to say that this is okay for me. And if they say, Yes, this is a great concept, having that similar to having a K number in the United States that builds the confidence in that manufacturer, and that builds the confidence that their regulations were acceptable, so they may be able to leverage that and look more favorable upon organization to be able to market products into their country and makes it a little bit. It could make it a little bit easier to get into those countries by being part of the Mds program.

Wonderful. Thank you. I'm gonna go ahead and in the poll a little early and show the show the results. So very interesting. And yeah, let's continue.

Okay? Great. Well, under the concept of the the program. Which is not probably not. Not. Surprising. Again, you have the regulatory authorities and and the auditing organizations, and the manufacturers, and SIM symbiotically in some way we have, you know, obviously, the auditing organizations which audit and certify the manufacturers. And then those auditing organizations do have a sharing of those reports under the reps platform again. And of course, the Ra's making regulatory decisions. One of the biggest keys here to note is that when something happens, good or bad. people know about it. Okay, when you're under the Mds program. I think that a lot of manufacturers and I've been asked as I was an auditor for a very long time, and I'm sure, Sebastian, you're asked all the time.

Yeah, you know.

Well, if if you know who's gonna know if if something happens under Mds when you get when you have an audit and there's a, you know, there's there's information from that audit. Governmental regulators share this information with each other. Let's not be surprised about that. Okay, so yes, your information about your your organization is going to be known. So it is a sharing of information, so that there is an understanding that you know each each jurisdiction knows what's happened, based on what has gone on in the audits. Okay, obviously, this comes into bigger play when there's a bigger problem whether there is a, you know, a a high level non conformity, or there's a an issue with a field action or things like that. So yes, there is. There is. There is country to country sharing of information.

in the very beginning of the program. That was a concern of manufacturers, because if I get an audit somewhere is that is that governmental organization gonna go run and tell somebody else. So again, under Mds, there is a sharing of that information. So the audit criteria again just wanted to outline quickly. And you'll see in red here the latest update to the program. So the audit criteria again includes 134-85-2016, which is been out for quite some time now. and each of the governmental regulations there, Canada adding part one of their sor. and of course the other parts of that play from Japan and the Us. And and of course, and visa with their Rdcs.

so this is why many of you that have Mts. App certificates, or those of you that are going to go after Mds app certificates. And again, this is all transparent on the website. You will see what will be specifically listed on your certificate. And Sebastiano again, I think we go over this later. But you know, when you when you are marketing, or you are selling into a jurisdiction under Mds. You are not allowed to exclude that marketplace. the under the audit approach. So again, many of you may have had audits already, but those of you that have not there is a specific sequence under the audit approach that takes place. And again, the audit approach document

which you will also find on the website outlines this and that of fact. This is exactly where this is taken from. One of the biggest things to note is that it is methodical. There is a rational reason why we move through management and measurement, analysis and design and production, with, of course. the links to, of course, the opposite the the right side of that screen there with, the device, marketing and authorization and facility registrations and adverse event reporting obviously an ever present topic in there. Each series has an audit, a number of audit tasks, and you'll find that a lot of your organizing organizations will go through in this sequence, whether they have one auditor or or more in a, in a, in a, in a certain specific order. Biggest thing to note here is risk management, and I want everybody to take a look at this. Look at the gray around the whole thing.

This is to accentuate not only what the 1,345 has already talked about, and what queue Sit had talked about before. But to ensure that really what this all comes down to, besides safety and efficacy, which is what everybody's heard throughout their entire Md. Medical device. Life is that the risk management is, you know, central to all of this, and and is fully encompassing of the audit approach in every aspect. So we see that in 1,345, through product realization, as we call it. but risk management goes from the top management all the way down through your entire quality management system. Looked at equally.

Brianna, let me say a few words on the sequence. So because this may appear quite rigid. The recently they regularly the Raka have opened a little bit to flexibility especially because the auditing organization and auditors were feeling a little bit too. Tie it in this. In this sequence. So meanwhile have been introduced some flexibility again. But the the core thing is that management today, the process and measurement, analysis and improvement, and they link the process need to be ordered prior to the product realization process. So depending also on the sides of the company on the end and on the number of auditors the auditing organization can audit, for instance, design and production in parallel. After having reviewed, for instance, the the first management and

measurement, analysis and improvement.

Excellent point. Yeah, excellent point. Thank you for that.

What? Thank you.

Under the program. We do see a difference in grading. And again, where many people are typically used to major and minor non conformity grading from what was the Ghtf which a global harmonization task force grading of N, 19 9, 4 is a graded one through 5. This numerical approach, which takes on a difference between quality management system and product related information. We won't go too in depth with this, because, there's a lot to say. This could be a whole session on just just this. But just to note that no there are in the gradation of this there are grade fours and fives which become increasingly more important in the sense of action that needs to be taken prior to the granting or the maintaining of certification.

as you can see here in the last bullet item, when there are 3 or more grade fours, or one or more grade fives. The Ao is also required to report this to the rack. So again, we talked a little bit about that transparency within the program. and the understanding that when an audit result gets to that level it is shared amongst all of the different governmental authorities to ensure that the information is known to each area, because product may be sold into any of those. And even if it's not, it may be sold into those areas. So that's an alert if it will. So the EU situation. So, Sebastian, I'll have you step in here once.

Yes. So 1 one question that often pops up is that what about EU? Because EU? It's has its own system. Now with the publication, we of Mdr. And Ivdr. Made the requirements much stricter compared to what was before under Mdd. And Ivd. So I say, why, then, they are not try, they are not, is not utilizing it so, there are several reasons, even though later we will see that there are lots of efforts now to to try to come one towards the to the other. So the main problems are the competence requirements which on in the Mdr. I ivr. Defined in the regulation

itself against the N. 4 document which is valid for Md. Sub. And the basically they are not aligned. So in a Mdr and Ivr especially for the product specialists are are quite different. They're quite tight to satisfy. Yeah. And also the other big problem, as also we saw before, even for to fly land the most of the biggest auditing organization, who are also notified bodies, but legally. the the Ao is different from the notified body. Right? So the for this is also a difficulty, then, for the notified body to recognize under Mdr. And Ivr. All this done by an auditing organization. But this can be easily overcome for those auditing organization who are also notified body. I will explain to you

later. Yeah. And also it has not been they find how a notified body can use a M. This up report or certificate. With respect to the product liability. Yeah. And under Mds up is the the product authorization is under the the jurisdiction responsibility. So the device. Licenses are always up to the a rack. So the auditing organization is exclusively responsible for for they audit, while a notified body is responsible for the All Ce. Market, which means the product related approval, and the Qms. Part. So before thence comes the question, if a a notified body accept another 3 part from the A, a, maybe different. O, then who is going to be at the end responsible for the product? If something happened

this is another issue that creates problems and also a agreements. And the the different rack under m this up f mutual agreements to operate under a Md. Sub program, while E. European Union is is not considered as a single country. But A. A group of countries of the single European countries. So which means that to implement certain requirements are are required. A agreements among all of them, if you consider there are 27 countries is is getting complicated. Yeah.

Just to just to accentuate that point. So right now, every of the 5 jurisdictions that are under MDF. Each one has a contract with the other to to ensure confidentiality of sharing information of a manufacturer for the European Union. It wouldn't be just one contract with the Us. And one contract with Brazil and one contract with Australia, it would be 27 different contracts with each of the other 5. So you can see how legally this becomes a bigger issue, with not just joining Mds. Very quickly for the European Union.

Next, let's go to the next.

So, yeah.

So then, what are the efforts now? Currently ongoing? By the EU authority to kind of recognize md, sub. So in 2020 was issued this Mdc. 2020, 14 guidance document, which was a a guideline given to the notified body on how they could use the Md. Sub reports for only taking into account as a input for surveillance audit under the EU regulations. As a matter of fact, this didn't go much ahead. So a a for the time being notified. Bodies are more. They are performing a combined audits, mds up

and the EU regulation rather than considering Mds up audit reports as an input for the Mdr surveillance audit. Another effort is the Mdc. 2022 17, which is a position paper on hybrid Audits. And from this point of view Mds up is much more advanced because has already published the Pilot program which is documented in the p. 0 36, which is con publicly available. allowing perform the performance of hybrid, audit and hybrid audit is an audit. When you have at the same time at least one auditor on site and other auditors or experts to connect it remotely. Europe, published this N. DC, which is just a very general guideline position paper that says, Yeah, we are. We agree to hybrid audits. But there is not yet

a guidance document that defines precisely the rules. How to apply it, how many of these can be on site? How many remote and so on. But it's a draft prepared by the an envelope group. It's about to come soon. Yeah. So we are expecting in really, in the in the next few weeks, to be Pla. Published, and from what I I have seen it will be quite well aligned with the Md. Sub so this is another step to allow performing combine all the time. This up EU regulation. The other thing is that they participated the last forum in Brazil in October 2023, and they will massively attend, including you manufacturers. The next forum, which is planned in S. And in Germany at the end of June 2024 in in the next months. So therefore, there is very good will to try to come

in a a good agreement on how to use or to harmonize the 2 programs. Let's say, Yeah.

Alright. So the biggest thing here the takeaway is that the European Union is becoming more and more involved with attending and watching and observing what's going on in Mds app. So that, you know, maybe maybe there's can be some synergy in the in the future. Connects.

Before we run out of time. And so this is a fun question. How confident are you in the your ability to meet the Mds. App requirements.

Yeah. excellent. And so, as you do that, I'll I'll go over the numbers here. We have 6, over 6,800 facilities that is, up from 2017, as you can see. So we have a a little bit of a meteoric rise in the program. With over 22,000 reports submitted. And over 59% of the audits coming in with a with at least one non conformity and on the right hand side. You'll see a little bit more about the Nonconformities. You know the information about how many there were. There's also a 5 day audit notice report a 5 day notice is, a more, a particularly more important notification that goes to each of the regulatory authorities. For

for significant issues that have been noticed during audits. And, as you can see, also, there's been some issues and and not a lot. Of course, with respect to the percentages. But there's been a couple of public public health threat fraudulent and counterfeit products but again, one each. So so it's not really a lot there. But the program does allow, as I mentioned before, for the Regulators to talk amongst themselves about what the issues are happening with the manufacturers percentage of the sites by country. You can see here, the Us leading the way in the 40 percentage. But as you can see the other countries there, and of course the rest of the world. This is just a little bit of a slide to give you a a flavor for how? You know who's applying under Mds.

And how it's being used. And with the non conformities themselves, let's pull a little bit more data out of that. And where these non conformities are being cut, we said, there's over 22,000 non conformities. And as you can see, the bulk of those non conformities are the grade. 3 non conformities. And for those of you who understand the grading system, obviously, you'll you'll see how these come about, which is from internal audits, Kappa, and of course, responsibility, authority, communication. I don't think that anybody out there is surprised that Kappa is in that group. the internal audit is in there as well, because in many cases

there has been information that people may not be implementing competency under Mds app in their auditing roles. But, as you can see again, over 49% of the audits have resulted in at least one or 2 non conformities in this particular sense. And now we can go into a couple of issues that have come up with some of the combined audits. So that's Johno. Maybe you could take.

Yes, that's all. Yeah.

Slang.

Just to put to put the focus on the advantage of combining audits for Mds upper and EU regulation. So they they at least at the big auditing organization. Notified bodies are doing that, including to Freeland. And the good thing is that with one audit that you will cover the the Mds up, and of course, the regulation. and which is much better than doing, having 2 separate audits, and of course, in a combined audit the audit time will be longer, but at the end will be once. Yeah. So how then the auditing organizations and notified bodies are doing these audits. So the auditing has to be done, based on the audit model. So on the audit approach by following the sequence

We have just seen before A and the the EU regulation, as a matter of fact, is treated as as an additional jurisdiction. So for instance, when we audit the vigilance reporting we will cover the requirement of the individual and this up jurisdiction, and then we will consider what's going on for for Europe. In some cases we we plan usually in the individual sessions. Because it's more practical to be used. And under Mds Mdr. We don't need to follow the sequence, so, detaching some sessions from the audit approach makes easier also the split of the of the audit team. But what are the challenges? Of course. So the planning gets more complicated. There are different competency requirements. So the for the auditing organization have to have to match the different requirements. Competence requirements under the Mds app and EU regulation schemes.

The review of the technical documentation under Mdr. And Ivr is planned separately, typically before they old it. And and and sometimes, if times are not aligned, we do the old data under Mdr. But then, the certificate is issued 2 years later because the technical documentation is still ongoing, while for MDF. For Mds app, you don't have the bottleneck of the technical documentation. And and so they they auditor usually close earlier. A, and then this creates problem in when to do the next surveillance audit. Then that yeah, then the what are other issues? So is that found in in Md sub audit. So typically, what Brian was saying before they they manufacture applies to auditing organization only for those jurisdiction they would like like Canada, they need Canada. I apply only for Canada. This is not allowed under Md. Sub the requirement says that

a manufacturer has to apply for all jurisdiction without exclusion where they have active registration, or where they intend to sell. This is clearly say they're in the FAQ document question 95. So the for this is one thing that auditing organization are going to check during every audit next slide, please? No? Then this is also Brian mentioned that. So we go fast. So you need manufacturer need to be prepared when they approach an M. This up audit, because once you are in they out they will have a reporting requirements even from stage one. This was one of the latest changes that were introduced. If the stage one is the initial phase where the auditing organizations verify the preparedness

of of the manufacturer to receive the stage, to audit which is the actual on site the real audit, let's say if a a manufacturer has a active registration and fail stage one audit. The auditing organization have to report such failure, and then there rack will evaluate what to do with this information? What is, if it's severe or not that they willing, they evaluate the impact over the existing product registration. Similarly, similarly, if a manufacturer goes for a stage 2 audit, after having passes stage one. and then over there, they already there are several conformities found under Isot, 1345, or even under Mdr. They are they audio, to say, wait a moment. I want to stop it. I I realize I'm not ready. Let's do it. 6 months later in Md. Sub. This cannot be done. So all the plan test need to be fulfilled, and if this result in 3 grade 4

no conformity or more, or one or 2 or more grade. 5. Then it's triggered the 5 days notice mentioned by Brian before, which means reporting to their rack, so they everybody will know that the Audi test fail and they will evaluate the impact on the existing registry authorizations. Next, though. thank you. Then other problem this is a typical non conformity, we found is about requirements or not. Having satisfied the adverse event requirements. One important thing to understand is that for Brazil, Australia, and Japan, the responsible person, or this responsible legal person to perform the reporting are the local. Let's call it distributor, so will be the the Brazila distributor, the Australian sponsor, or and the Japanese. Mh, so the marketing auto authorization holder. So, therefore, the responsibility of the manufacturer is to stipulate with them, and make sure that every

adverse event. It's made which also involves product registered in those country are reported to the local distributors, and of course, the the agreements written agreements need to be in place. They find them. The mutual responsibilities also. The important thing is that the Us. And Brazil have these foreign vigilance reporting requirements, which means that if a vigilance case occur, for instance, in Europe or in Canada. and the same pro on on a product which is also reduced in such countries. The manufacturer needs to evaluate whether those cases are also reportable in us and Brazil. and and often that manufacturer fail to to make this evaluation, and in principle feel safety. Corrective action are to be reported in all jurisdictions where those products are registered, even if occurred in other countries. Yeah. Next

I'm trying to speed up because we are close to the end of the time. So yeah. Just few words Md. Sub in Md. Sub. There is no statistical sampling. But the the auditors during the audit to make a rational base sampling which is based on certain priority criterias, especially looking for potential quality issues or high risk product or processes where problems were detected. That's the the focus next up yeah. Other failure. It's about report W. Reporting of changes both Qms and process related changes. It's important to know design changes need to be analyzed for reportability under the single country requirements. And same happens for for Qms, typically for Qms is this

auditing organization that needs to be informed for design changes are the regulatory authority, or often this is not done, and even the auditing organization are not informed. The setting is that at the moment we don't have a guideline under Mds apple. Even the U. Regulation not to identify a Qms. Significant changes. The only tool we have is an all emboggument, the 2014 3 which was available under Mdd. And Ivd. But it still is very valid tool which can also be used as a reference under Mds. Up next, though other critical point is the Technical Documentation Review. Under end. This app the auditing organization have to perform a a technical documentation review according to their next 9, which is also needed under Mdr. Ivr. We are talking about 2 different things. So because of the fact that under end this app, the regulatory authorities are

approving the technical documentation, and before they all didn't go, organization is only to verify that there is a technical documentation in place is maintained up to date, and it's addressing the requirements of the appendix of the annex one. So it's mostly a consistency check and auditors dedicate one or 2 h typically during the audit of the design and development process under EU. This is a really conformity assessment process. Either based on sampling or to issue technical documentation assessment certificates. You can just to give you some numbers for a the the review of of a technical documentation, even for a class to a May range between 3 to 5 days, just as initial review. But this can be extended of several days, depending on the complexity or the quality of the quality of of the technical documentation. And because the review is under the so responsibility of the

notified body. Yeah. And also the qualification of this experts who review the technical documentation under Mdr. Vdr. Is much higher compared to the technical expert under Md. Sub.

Right. So there's a significant difference here between, again, the legal authority under the notified body for the review of product technical documentation. and that under Mds app, especially when it comes to competency. So in in many cases it cannot be a one to one issue. Sebastiano. Correct? So that in, you know, in principle. If someone says, if I've got a technical file that's been reviewed by a notified body. wouldn't that suffice under Mds app, for instance. You know, there, there are different competency levels and different approvals of the auditors, basically under each program that would have to be no understood. So, Shawn, I know Shawn, I know we're short on time here. We've only got a couple of slides left. How would you like to handle the rest of this

Sean, you're on mute.

Let's let's barrel on through.

Alright, so.

Okay? So this is another question that often pops up. So, Brian, I continue with that. It's what is then about medical device file under Iso 13, 4, 85, close 4, 2, 3. Is it the technical documentation? No, is not so under. This is the equivalent of a word that is typically using us, which is the Dmr. So the device, or the which is audited in Mds app under task 6 point the 16. This is basically the device master file, which is the medical device file is the file containing the production and product specifications. But it's not the technical documentation as expected or as defined in the annex one and

in under EU regulations. The Dmr. Is just a part of the technical documentation. So this is also important to understand. For instance, the technical documentation and the annex one, or under EU regulations, includes all the test reports, the clinical evaluation all the tests made on the type. Yeah. So this is important to be kept in mind next.

Right? And yeah. so again, again, this is more more on the technical documentation and the qos part as far as the contents. And if if those of you that will look at the audit approach, and of course, the Nx. One, you will see a section called Technical Documentation and how it is being used. A a lot of programs around the world are using 1345, as I mentioned, as the basis and looking into the European unions. Mode of using technical documentation but again, it is. It is more of a consistency check rather than a product check under Md set right.

Yes. And here just one last thing is the technical documentation in. And this app, as well in several other countries, including you, is harmonized to the to the stead file. So the for the manufacturer typically as a good approach, they built technical documentation with modules where they include the country specific requirements. This way, they will avoid to have multiple files containing the same information. Yeah. especially for those companies who goes internationally. Yeah. Yes, these are the question that often pops up. If you are, I'm a medical device organization, which means I'm like a subcontractor. I'm and that this organization doesn't want to go on the mark in the, on the market with under its own name. Can they apply for Mds up?

So the question is, yes, but it's on a voluntary basis. Formally, the program is not open to these Mdo for managing or resources. So they are the rack. Don't want at the moment to open it but still under the is all on pure voluntary basis. For instance, if if an Mdo. Has a customer who has a Md. Mds up, and they are asked to get the certification. They can get it. There are some limitation, and the approach from the value. So leading organization is not harmonized. But this is going to be a topic we will discuss again at the next forum next month. Yep, next.

That's all we have for today. I I apologize for going over by 5 min, Shawn. But We were able to get through some of. I think it was important for the public to know some of the from Sebastianos lips some of the information that then the auditing organizations are seeing out there as far as the pitfalls that some of the manufacturers might have and might account but I I hope that that was well received in that manner, and and appreciate the time.

Yes, and thank you both. And everybody stayed tuned. So let's I'll connect with you to in a minute. Okay. I'll send you out. Okay. okay, thank you. Bye, bye.

Thank you. Everybody.

Bye, bye.