Understanding Harmonized Standards in Europe: What Manufacturers Need to Know for 2026

Baker will be joining us shortly. Hey, everyone. I'll promote you to panelists. If you don't want to be promoted, then just decline. You may get asked again, I apologize for that. Let's see, we… We'll be starting shortly. Oh, boy.

So I've spent the morning on, support calls with GoDaddy trying to resolve a domain forwarding issue. I don't know if any of you love domain forwarding issues as much as I do. Meaning, not at all. I find… the whole… thing with websites and web hosting, and forwarding, and redirects, and DNS and all that stuff to be an absolute nightmare. To deal with. Unfortunately, it's one of the things that… Having a number of websites. Requires one to figure out.

All I can say is that ChatGPT is the only thing saving me. Because I just take screenshots and ask it, what the hell is going on? And that actually works. So… I, I do it regularly. I'm… I'm always uploading screenshots into… Into ChatGPT… Let's see… Japan alone. If you don't want to be promoted to panelist, just, decline. Perhaps an easier way to do it would be if you want to be promoted to panelist, raise your hand. I'm not sure.

Where is Ben? Ayy. Matt, how are you doing?

Muted. Lower left. Hit the unmute button.

Now it should be better.

It is better. Welcome.

Now it works here.

How are we doing today?

Fine. A lot to do. And how are you?

I was just telling the poor people on the call that, I've been struggling with a domain issue… domain forwarding issue this morning, and on the phone with the… website hosting company trying to get it resolved. Hopefully it will be resolved. I find, domain forwarding and DNS and all of the things involved with websites to be unnecessarily complicated. Or…

Yeah.

unreasonably complicated might be a better way to put it. I'm sure it's necessary in their mind. in whoever, you know, created this whole DNS system, but whatever it is, It's, It's, not… not my favorite thing in the world.

Quite something complicated, yeah. Stuff.

Yeah.

So…

So, we're ready?

so.

Oh, good. Let's see, I probably have some announcements that I can go through now. Let's see. So, If you have, questions, feel free to use, either the chat or the… Q&a function. And, we'll try to work your questions in. Your other option is to raise your hand, come off mute, and ask your question live. For those of you who don't love typing, like me. That's a fun thing to do. We're also going to…

Let's see… sorry, I need to send a message. Have some upcoming events that we're gonna let you know about in a minute. I'll put those in the chat along with links.

Hey!

Hey, did she say? Okay. You can start promoting people, I… Tried to promote about half of them, and they declined, so…

I'll get it. I'll do it from the, usually… I have… One minute before a 59, and then a start, so don't worry.

I'm making you co-host. Confirmed. And… Just for fun, I'm gonna make Bayat co-host as well.

Confirm.

You know, I was thinking about something funny this morning. I was thinking, you know, your name is Beat, and people probably say that wrong all the time, and my name is Sean, or Sean, which people say wrong all the time, and so then I was thinking that we could call it the beat scene, you know?

Yeah, I mean, people speaking English, they always say beat. Right. I'm used to that, in the meantime.

Well… My name is actually much worse, because it's Gaelic, and it… no one… understands that, so unless they know, you know, Sean Connery, Sean Penn, then they tend to…

But what's… what would be correct, Sean?

I don't know.

Sean.

Yeah, it's just not a phonetic spelling, it's not any… it's Irish, so, you know, it's just written in Irish, in Gaelic, so… It's, yeah. Some of the Irish names, like Siobhan, Looks like Sibohan. Things like that. Yeah, so that's… That's fun. Let me see… the upcoming events that we have… show, I think next week, Michelle and… Tiana from Lean, Rocco are going to be talking about FDA, and what it's up to, with regard to warning letters and a bunch of other things. I'll put all that information in.

And then we also have a great PMCF thing happening next week. I'm also gonna drop the link to the, Latest update, the latest recap from… MedTech Leading Voice. If you could drop a like on that, I'd really appreciate it in the moments before the call, notification. So, yeah, first, here's the link, please, Show some love to this post. It needs it. So, interesting thing with, LinkedIn is they are…

really seem to be prioritizing boosting posts and trying to make money off of everything coming and going. So, I think it's gonna be really important that, people in the med tech space just support one another to circumvent the, you know, the fact that they're just, you know, trying to gouge people for money and be like, oh, you want your post to get seen? then pay us, otherwise we're not sharing it with anybody.

We have more people coming in. And… it's 11.

Oh, is it 11? Okay. Let's get started.

John, you wanna say something before I stop?

Yep. So, good morning, everybody. Welcome to Friday in Focus. Today, we have a special subject matter expert, Bayad Keller, and he's going to talk to us about understanding harmonized standards in Europe and what this means. So, without further ado, I'm gonna turn it over to him. I'm gonna mute my microphone for the time being, and, I hope that, many of you will, come off of, of, Mute and join in the conversation, and… or use the Q&A function or the chat function to, participate in this. We're hoping for an interactive discussion, as usual. And we'd love to hear your questions, your insights, you know, don't hijack the call, but, you know.

Give… and let's… let's get started, Beth. Hello.

Okay, thank you, Sean, for having me here, and the invite, and… Good morning, evening, afternoon, night, wherever on this planet you are. For me, it's already a later afternoon. So, I'm gonna talk today a bit about the harmonized standards here in Europe. Some, quick introduction of myself. So, I worked… For quite some years as a software engineer. for medical devices, I developed mainly ventilators, HCM machines, stuff like that. Then more and more positioned into quality regulatory. And I'm a member of different working groups of standardization, so I work actively in the harmonization and the standardization process.

And as a member of the Working Group 2 of Senelect TC62, I'm also part of the team writing the set annexus and the European forward, which we are talking about today. So, that's all about me. Let's start with the real agenda. So, I wanna talk about… where is it coming from? Why do we have this kind of standards? how is the harmonization process? It's something often people, mix up? And then the question is, how do we work? And then I have some examples. So, in Europe, we have this new approach. Well, so new, it's not anymore, it's still called the new approach, but it's already some decades old.

But the idea behind that is that in the EU legislations, whether it's a directive or a regulation. It's more higher requirements, or the essential requirements, essential objectives, which are defined, but not how to implement it. The how should be in standards, in specifications, and stuff like that. So that we can… Somehow, split off what is illegal and what is technical. And… The idea is, furthermore, that we have this kind of harmonized standards, what processes, I will explain later, but a hormones standard will make the… Presumption of conformity.

So if you can show that you fulfill the standard, the conformity with the legislation is presumed. You don't have to explain anymore to a notified body, or to an agency, or a co-plate authority. Biosync, you fulfill the requirement, but you can presume it. And the target is to get more consistent, faster conformity assessments. That's the target behind it. In the EU MDR, this use of HARMA standard is regulated in Article 8. Where we exactly have what I said before, that we can use HRMAS standards, And… this,

camera standard can be used, especially for the requirements in NX1, so the general safety and performance requirements, which you need to show that you comply with them. What is important, we will come later again on that, is presumption of conformity only applies there, where the standards covers the relevant requirement in NX1. Then, another question which often pops out with the standards and the MDR is state of the art. What is a state of the art? And state-of-the-art, in principle, means the current accepted level of technical development, so what all the companies do.

And a standard which is published, which is internationally accepted, is a strong indicator of state of the art. So, if you want to show that you're state-of-the-art, one quite good and strong possibility is using most current standards. Which are internationally accepted. You don't need to, use the standards, you can do however you want. But if you use other ways of showing state-of-the-art, you need to justify and provide evidence. What is a… Harmrest Standard. A harmonized standard is not a standard which is published as an EN version, what a lot of people think, this is what I wrote here in the middle, just because it's an EN standard, it is not automatically harmonized. A harmonized standard is then when it is published in the official journal of the European Union.

So this is an excerpt of the first publication of standards for the AMDR. Quite some years ago, in 2021, when the first couple of standards has been harmonized.

Where can we find, all the harmonized standards?

So they are published on the website of the European Commission.

Hmm, okay. Somebody want to find that link and put it in?

And if not… if not, I will do it later when we discuss. What is important is what I have written down here. So, IEC standards, they are globally recognized as state of the art, but they are not harmonized automatically in the European Union. And how is the process? So, how does it work until we have a harmonized standard? Catherine asks, or put up the… her hand. Please?

You want them to put up their hand of what?

No, I, soon showed… showed that someone… Put up the hand to ask something, but they.

It was… it was a mistake. It was a mistake.

Yeah, okay, I've seen it. So, I continue. So, if we… look on the process to get a harm red standard. The first thing is. European Commission needs to identify the need. select the MDR. where the European Commission said, okay, we need some standards, and then they have to mandate the European standards organizations to write and provide such standards. Usually, This is, Sen and Senelec, which are the European levels of ISO and IEC. And for, everything which is with, Radiation, so, like, radio equipment, it's not only ISO IEC, Sansenelec, but also ETC.

So, the European Commission provides a mandate to this, Senelec or Etsy to write such standards. then these organizations draft these, organizations, these standards, which is the next point here. And often, these standards are the international versions, so an ICO or IC standard. which get the European forward at the Zetan axis. And then gets published as an EN version. So often, from the content side, it's nearly the same, just the, Forward at the center axis is the difference. Once the Senelec have written or drafted this standard, they go to the HAS consultant. A HAS consultant is a harmonized,

Standard consultant. And they are… lawyers, mainly, which have the mandate from the European Commission to assess the standard to see whether it really fit the needs for the mandate, and provide the feedback. If needed, Sense ANLEC will update the draft, so that it fits what is needed for the NDR. And then, when When this process is done, a standard is published, and it gets also published in the official journal of the European Union. And then, when it is published in the European Union's official journal, then we have this standard as a harmonized standard.

Come on. Yeah, that is what I already said before in the graphic. So what are these SATA mixes for? What… why do we do that? In principle, it translates the standard clauses to the specific GSPRs. or whatever it is called in the other regulations in the MDR and IBDR, it's the GSPRs. So, we map which part of the standard covers which requirement in the GSPR. But not only it clarifies the coverage, but also the conditions and limitations. Sometimes it only limits to a part of the GSPR, or only in regards of some specific points, but not overall.

So, in the end, we have somehow a traceability from standard close to the GSPR, which then, you can use as the evidence to fulfill the GSPR. In the national forward, in the European forward, you have Some dates in there. You have the adoption statement. which is quite often approved without any modification, so this confirms that it is technically identical to the IEC or ISO standard. But I… At least from a technical perspective, it is the same. Then… You have some regulatory stuff written in there, and if needed, some national or European conditions, especially earthening or conductors and stuff like that is sometimes different.

Who writes it? This is, mainly Senelec. As I said, it's also Etsy for the radio equipment, quite often. And within Senelec, for the medical devices, it's the Working Group 2 of TC62. These organizations and working groups have their own guidance documents, and one of these is the cookbook we wrote about 2 years ago within TC62 Working Group 2. on how to write this, set annexus and the national forward, or the European Forward, so that it's easier for the colleagues, to continue the work. What is also important is The same as for IC and ISO standards.

the, National Forward and the satan axis. get reviewed by the national committees in all the general countries, so it's not just, two or three people from working group two, which write it, and then it directly goes to the HES consultant, but also all the national committees can provide their feedback.

There was a question.

Yeah, just saw it, there is… one of the next slides exactly about that. So I was phoned a question to, A later slide. So, what does the HES consultant do? What is evaluated? So, we have, as I said, this linkage. So, is it really, complete? Is it clear? Is the scope aligned? Is, Is it fit? Is it technically suitable for the presumption of conformity? So, is it more specific? So, this is one point, it must be more specific than the law. It must have acceptance criterias. And, yeah, often this linkage, normative references are…

Feedbacks from the HES consultant coming back, or the defined terms. And, give me a second, Edway. One of the defined terms… give me a second, I'll just come to you. One of the defined terms we always had this discussion is patient. Because at the AMDR, a patient is a human. In IC standard, a patient is a human or animal. So, we have, two different… defined terms, and so, also this is something which is, checked by the HES consultants. Bedrooms. You're friends.

14971, we had a Haas consultant that would not, approve what was recommended by the Sen SENLEC Committee And, it… it got to be kind of contentious, but then, his contract expired, and we got it through with the other two Haas consultants that did approve it. So it's… it's kind of a… Difficult situations sometimes.

Yeah, definitely. And, I mean, it's always… you can ask two lawyers. And you have at least 3 different answers. This is, you know, in everything, if you ask two lawyers, you have three answers, and… Yeah. That's often an issue. But thank you for this note. Yeah, the first part I already said, homework standard status starts with the reference in the official journal. What you need to always have an attention to the version which is listed, and transition cessation cessation information. So, they say until when the standard is

recognized, or… Has this harmonized status, and when it will be deleted. And you should, state that in your technical documentation. And now to create the question which came, repeat. Some years ago, we had this, Global Gordon and James Elliot cases in the European Court. Which, in fact, said… this is my technical terms and not the legal terms. Lawyer would probably say different, but in principle, it said. If a standard is harmonized at use for presumption.

It has somewhat of a low similar characteristic. And this was somehow new for the European Union, and the Commission, which then said, well, if the European Court sees this as a legal or nearly legal document, then we need to, reconsider formality and scrutiny and all this stuff. So they started to reconsider all that and implement additional checks. And while doing that, the contract to Ernst & Young, expired, so there was a new tender and all this process going on.

So that in the end, Ernst & Young, again, got the contract to Provide these, harmonized standard consultants. And when this contract came out, it was published, and ensign restarted their work. All the working groups, which have been waiting on the Haas consult that, yeah, we can continue, let's get into the racing car and restart. But… Yeah, the restart was quite short, because the European Court made another decision. in the Mahamut case, which said, well, if a document is legally… a legal document, it must be publicly available.

And now we have the thing that this… We have a document, which is… Seen as a legal document. Which must be publicly available. But which has a copyright from IEC or ISO, Senelec, and so on, on it. And the court stated, yes, this is a copyright-protected document. So, how do we provide public access? For free, through a… Copyright-protected Document. And this discussion is still ongoing. So we still have this, legal uncertainty about the copyright.

This is the reason why it is, again, quite slowed down, and… The main focus currently is on… pure EN, so the homegrown standards, which are only EN standards, and not ISO or IEC. standards, which got the NEN version, but there it's a little bit easier. We have a little bit less people, working or discussing in this legal uncertainty. I hope, Pete, your question is answered in these regards. Nope.

Is this, again, your hand-raised bill, Edwin Bills?

Yeah.

Yep.

I saw the comment on the chat, too. The FDA had the same problem with ISO 1345 and ISO 9000.

Yep.

And there's an agreement through ANSI to make them publicly available read-only. You could not print or copy the documents from the website, so that's how the U.S. addressed it. Same situation you're talking about there with the copyrights.

Yeah. So, this is also… there are a lot of discussion. I mean, in Switzerland, we have a same or similar situation. Also, in Switzerland, we have a lot of references in our laws to standards. So it… gets quasi, low. And people need access. the word… the solution we had here in Switzerland is that we have, I think it's four places spread over It's quite a small country, a little bit smaller than the US. So, four places are sufficient so that everyone can go within a reasonable time to this place. And read the standards, for free. So I think one is in Wintertour, one is Zurich, one in Geneva, and so on.

And you can read the standards if you want to see it without paying. what, in the end, the solution will be for the European Union? We will see. It's not yet… it's not yet figured out, and until we have a solution for that. I expect the process Jeeps. slowing down. Or more or less blocked. What can you do when we have no reference in the European Union Journal? One is using the newest version of the standard to show the evidence of state-of-the-art.

Then you need to build, somehow, your structured argument. Why is it applicable? Where do you map it to which requirement to either GSPR checklist? Where do you see any gaps and initial controls? And you need to clearly, again, document that in your, technical documentation. And somehow, I suggest the same procedure if an outdated version is harmonized. I will have an example later about that, how I often do it. There is no perfect solution, but I can show how I usually do it. What the notified bodies typically expect is this clear mapping, again, the handling of the gaps and deviations.

And often you don't say, okay, we, fulfill this GSPR, requirement by, By a certain clause of a standard. So you provide the test report of that standard, but don't only provide the test report of the standard, but also where the real fit this, so your risk management file, a usability document, VA document, whatever, not only the… I see a test report, because often not web bodies don't accept, only having this report. They want to see the real, content of… The, the evidence.

And now I have here some… some examples how this could look like on the… Left side, you can see this, table set set 1 in the 6601. I know this is not yet listed in the official journal. This is exactly that, so we went through the process with the HES consultant already in this with the standard. But then, we had this Malamut decision, and everything got somehow blocked, so we have already the set an access in this published EN version. But it's not yet listed. But, anyway, we have this… Least? Of the… is the table sets at 1?

Y1, there is… there are two more. There is a set set 2 for the IVTR, And, no worries. For the, for the, not the IBDR, for the machinery. Maybe I have another table in there, sorry. Anyway, in this table, we have the general safety performance requirement. In the first column, in the second column, we have the clause of the standard. Which, covers the requirement, and we have a remark. So, whether it is really covered, Not covert? The not covered are not always in the standard. Sometimes the not-covered ones are just, not listed.

Or conditionally covered. In this example here, for the 10.2, it is covered for cleaning, disinfection, sterilization, and design and manufacturing. But packaging is not covered at all. When you then go to the corresponding part in the GSPR checklist. This is the checklist I've taken out of the MDCG guidance. Most companies do it somehow this way, all the tables look a little bit different, but in principle, you say, is it applicable to your product, yes or no? Which standard have you used? Or a common specification, and which part, whether in full or only part.

So if you have here just this closest, then… Put the closest also in here. Then the evidence of conformance, so that's what I said before, don't just write down the 6601-1 report, but also, in this example, the material list, or a drawing of some surfaces, or a packaging test report, and so on. Then you have your last column, where you can, clover… Question about, is it a harmonized standard or not, or why have you used this standard? It is not harmonized yet, so I would write here that I used the latest version of a standard. So, what is in the chat?

Yeah, EBS, yeah, okay. So I go back here to the example 2. here in, ISO 4971. This is already, the standard is already published in the official journal. So, this is a harmonized standard. You do the same again. You can copy-paste what is written in the table, set. a 1 into the, GSPR checklist. And here, the ZA2 is the one for the IBDR. Which I mixed up before. Then, what is important, what a lot of companies overlook is in the…

And yeah, or it is written if… Your medical device is also machinery. You also need to consider the machinery directive. It will somewhat be replaced by machinery regulation, but still, it is the machinery directive at the moment. And in the machinery Directive, you have the relevant essential health and safety requirements. And the NDR says you need to comply with them. As far as they are more detailed, or, More specific than what is written in the NX1 of the MDR. And so that you don't have to do this research, is now the MDR more specific than the machinery Directive? This was already done by Sen or Senelec in this table set set 3. So you see in here which

Parts are more specific in the machinery directive. And which are covered in the standard. So, again, if you go down to your essential health and safety climate checklist from the Machinery Directive. You see here, only intents 5, 7, 9, 10, and 11. are more specific, so 1, 2, 3, 4 are not. 1, 2, 3, 4 are not, so we say, no, not more specific. In the fifth one, yes, it is more specific. Yes, it applies to our device, maybe not. And then you can refer again here to the 6601-1 with corresponding closes.

So, we have two questions. What makes a device a machinery? I don't have the text now in front to show you of the machinery directive. There is a quite detailed definition in the beginning, like it is in the MDR for the medical devices, but in principle, if you have something which moves or turns. with, power, which is not human power, but electricity, or… climatic power, or whatever, then you probably are also machinery. So, for example, a ventilator, To ventilate the patient, to… Which cannot breathe, which has a turbine in there.

To, provide the air to the patient, to compress it, to provide it to the patient. is a machinery because of this turbine, which… Pressures up the gas to be inflated into the patient's lung. As an example. Or if you have a trolley, which has a motor to move around, you have also machinery. Or an electrical bed, for example, which has a motor to move up and down the leg, or the head part, is also a machinery. What do we also have? Where is the Z3 published? So the set set 3 is, published in the A13. So what is important is

You don't find it in the IEC or ISO version of the standard. This is only in the EN version. And what Sense and Elect try is to get it published. With the same time the international version is published. Then we don't need any amendments. If this is not feasible, like it was in the 6601-1, Then the, set on Axis and International Forward get published in Its own amendments, and this amendment then starts with, 11, 12, 13, so they have a two-digit number.

So, another example I promised to show you is what we currently have with the 10993-17. Some, years ago, the, 10993-17, 2023, Was, published in the official journal. So it was in, 2024. And since then, this standard is… the harmonized standard. So for this version, the 2023 version, we can presume conformity with TMPR. But now we have an Amendment 1, which was published last year, 2025.

Now, what do we use now? We can use state-of-the-art, which is probably the management 1, 2025. But harmonized without the Amendment 1. And… Not every notified body sees it the same way, but in fact, usually, as soon as you have a newer version. And the MDR always says you need to be state-of-the-art. They expect you to go with the newest version. The most extreme I have once seen is I had a client Which had an audit about… what was it? I think it was about 5, 6, maybe 7 days.

After a new version of an international standard was published. And this client got dimensional conformity. Because of being not state-of-the-art, Because not having already adopted the documentation, 7 days after the publication. It's for sure, a quite extreme, point of view, but… It existed. what I often do is, I list both. I leased the, version which is harmonized. And the one which is, state-of-the-art, so the newest version. And they show, is there… is there a gap at all? Sometimes, especially in corrections and amendments.

Which are quite small, it has no influence on your device. Then, at least you can show in the gap assessment that you have assessed it, and are working on it, or you don't have to work on it because it's not relevant for your design. So we've got a lot of other… chat messages. Let me quickly check. Okay, so what is a theoretic? That's what I see.

Yeah, they'll still argue either way. It's a no-win when you get in a situation with a notified body that way, I'm just gonna tell you. And I've tried it both ways with that, and they'll still argue either way.

Yep.

You can have both, both, both of it. both arguments in there. It's state-of-the-art, either you have to have state-of-the-art, per the EUMDR. Which is the newest standard, and you need to put both of them in there. In my opinion.

This is… yeah, this is also what I made the best experience, having both in there.

Daniel may have opinion as well with his experience. And usually, my experience will win out over the notified body evaluator, and I always opt to go up, but that's… Yeah. Yeah.

The old me. The only thing that I can say about what you just said is that Sometimes it's the battle between what was the intent of the regulation or a directive, and then the opinion.

Correct. For somebody at the notified body, and getting.

these two reconciled sometimes is a problem. It requires a lot of… A great ability to sort of put the technical aspect in place in a way that it's… it's… It's not debatable, and that's… the problem.

You have to go back to the black and white, and you have.

Yes.

Through the… and you have to call them out on that, and call up, please show me in the regulation where it states what you are telling me it has.

Exactly.

And you have to ask them to show it to you in the regulation. And that's how you win that battle. Period. You can't. And a lot of times, they can't show it to you.

If, if you can… Yeah, yeah, if you can get them to go to the regulation with you, which is also a hesitation that I've always experienced.

Yep.

And they'll get… they get angry with you, but you have to stay firm with it and say, please show it to me in the regulation where it states that.

Yeah, but the one…

Walk them through it. and show.

The one which asks you to use the harmonized one will show you Article 8.

Yeah.

The one which asks you to have the latest one will show you 10 times or 20 times state-of-the-art in the regulation, so… both will find their, place in the regulation for their argument.

And you know, Kent.

It's your advice, and it's your testing that you've done, and it's your state of the art, so it's your.

Yeah.

So, I mean, when the reviewers come in, you have to be able to defend your device. And the savings are for your device.

So… And it gets worse when others have yielded before to the opinion of the notified body, and now you're the outcast. And so now you're the rebel, yeah.

It gets difficult, so…

So.

am I?

I also have, Krutia asks, doesn't it make harmization unneeded, especially when it is so delayed? Good question. I think it's also kind of a political question. And I'm a technician and not a politician, so… Yeah, I don't want to burn my fingers on that, but I can understand this question, yeah. And you mentioned that IEC standards may be for human and animals, but ISO 3485 is apparently to humans only. Yep, this is the difference between ISO and IEC. IEC defines a patient as animal or human.

And interestingly, if you, look into the… definition. of a patient in the United States. They write, that the patient is at a room. A patient is a human or other animals. These other animals, I find, is quite interesting. Because this means a human is also an animal. But this is another discussion. Yeah, so, we have Dave from Philip, another message in the chat, the argument from not-fact bodies is the as far as possible reduction. So, especially in the…

amendment we once got for the 4971 for the MDD, so the older one, which said… there was a statement in there, I don't have it word by word, but You cannot use it, As written in the text, to reduce it as far as reasonably possible, because reasonably would include somehow the, Also, a financial side, and so on. But you need to reduce it as far as possible. And now, in the current version of 4971, they wrote it differently, so they don't say anymore, you cannot use as far as reasonably possible. But they point you towards the different wordings which are used in the MDR. As far as

reasonably… as reasonably possible and state-of-the-art. So, you always need to show That you are still state-of-the-art. Which can be done by using a standard. And… Ashley has her hand raised. Whoops. Okay. I think I will continue with the next. I don't have much more slides, but some more I have, I would… I think I… okay, thank you, Ashley. Some common pitfalls. So, as we've seen before.

Sometimes we have not a full coverage. in the GSPR, so times it's only partially covered. So this, assumption is basically ignoring, Yeah, can, get you some… some troubles or no conformities. The limitations and annexes… the annexes. Current conditions in the forward, I already said in here. You have exactly this, what, we sat with the humans. In the set, set, annex of the 6601-1, in the amendment 13, It's clearly written for an application of this European standard under regulation that end. It is… its scope is limited to medical devices for use with human patients.

This affects all clauses of this European standard. We can say here. We know, we have in the… Definition said a patient Can be, A human or an animal, and here we override it by the regulation that it is only a human. So we have, hand-raised. Lotto.

Yeah, it's me, because based on from my experience from both sides of Ocean, like, from notified body and manufacturer, I work from both parties, I see, this is always, like, again, chicken story, and really pragmatic way of challenge for the manufacturer, because If we talk about any standard, the deployment will start, like, it takes 6 months, 1 hour, based on the delta changes, actually. And I think… I think now, after this many years, what I always feel is. there is no consistency approach between all the notified body. Every notified body has their own approach dealing with this state-of-the-art standard, and I think it's better to have a good dialogue with the notified body, and…

Come with an agreement, like, probably transition timeline for the new standard when it comes to state of the art. are, if it is harmonized, like, what would be the approach? So, I think that's the only best way to… for the manufacturers from the business strategy point of view, so… Yeah. I just wanted to add that point, yeah.

Thank you. Okay. Ian also take care about the versions, which one is listed and which one is published.

Yeah, yeah, it's better tomorrow. So.

keep, keep your conformity argument current is one thing, so check the official journal updates. And now, with, social media, it's, Much easier than it was earlier, a decade ago. As soon as a new version of the hardest standards list is updated. you try to first get a lot of LinkedIn messages, which tell you that it's updated. Also, check the versions of the standards and these transition dates, which are given in the Harmonized standard list. When needed, trigger an impact assessment in your QMS, to,

See what is the impact, what do we need to change, and so on. And, yeah, someone needs to be owner of this task, and not the regulatory saying, it's the design team, the design team thinks it's quality, and quality, again, points to regulatory, and everyone points to the next with his fingers. I once created such a form for a client, which we used when a new version of the standard was published, or an update of the official journal. So we put it right down. what the impact is to the product, or maybe there is no impact. And if there is impact, we had the possibility to write down what we do, when will we do it, with the due date, and we had the possibility to show that to

The notified body, when in the meantime he… Was asking, or she was asking for, what about the new version? So, what we have in the chat. Dark cocktails. Of course, I don't know, Philip, what this was.

The docopocus was formerly for the MDDOJC, the date of cessation of presumption of… of the superseded standard. We do not see that anymore in the latest, OJC for the MDR since 2021, and this is a problem for manufacturers because they do not have any transition period. When suddenly a standard harmonized pops up in the object, and so many manufacturers are complaining about that. And so, any insight about why the docopocos has disappeared?

Okay, see. Where do you see teams getting the mental model for all? Most of the day. So what I often see, issues is with filling out these tables. Like this one here. that, manufacturers just arrive in more or less every single line. It's 5601-1. Then the IC6601-1 report. sometimes even they write in here the IEC version, And,

Yeah, this is something I quite often see, that they don't really… checked. Is it really covered or not? And if it's not covered in here, maybe for your specific device. It could be that something is, for your specific device, covered anyway. Then you can write it down, but you need to have some justification why you think it is covered with the 6601-1, even though it was not considered as covered In the Saturn axis. But just writing from the first to the last, row of the GSPR, 6601-1, 4971, and…

One or two other standards you will fulfill, then copy-paste it. Through all pages, makes no sense. So… Yeah, it is addressed at the dash 2, dash 83. is harmonized at the 66 or 1S10. So, yes, there are I think it's about 4 or 5, 6601-2-something standard.

Which are harmonized, but the general one is not yet. But… it is as it is. Then we have another… Message from Hedrik. Patrick, I don't really get your, your question. Can you unmute unmute? And… tried to say it again, so… I didn't really get what you want to… Tell me. with your…

Question. Sean, do you get it?

I'm trying to understand it. I think it's really just a question of, what level of MDCG rank the clinical data need to be. You know, and it just gets into that whole question of, you know, what is sufficient clinical evidence? gonna look like at the end of the day? And the answer is just always… it depends on your device, it depends on the level of risk, it depends on the notified body that you're dealing with, it depends on the, the particular person within the notified body that you're dealing with. And… but ultimately, as I understand it, and Carrie, you can correct me if I'm wrong, it's how convincing you make your case

And how well supported that is by the clinical evidence. Clinical evidence is the backbone of the evidence that you're… that you're providing, and you can certainly rely on the standards. You can rely on literature, you can rely on a lot of things, but, you know. When you're dealing with high-risk devices, that's probably not going to be enough.

Yeah, it's clinical evidence and state of the art. You have to…

It's a…

Some reviewers can be so… Persnickety, I don't know. It can be… the PIA factor, right? State of the art, it's generally what is currently the… what is accepted as your best practices and technology, and what is the clinical standards for the current given medical condition. And it could be what is, you know, what is the current gold standard in the clinic? So you need to go back to what is recognized as safe, effective in the adopted clinical practices. So, you know, the regulatory contact goes back to the MDR, you know, if we're talking medical devices, 20, you know, 2017-745. It references

the, you know, SOTA throughout the regulation. However, it doesn't define it, right? So that's where we're all kind of sitting in this conundrum as to what is it in regards to the risk management, clinical evaluation? the benefit-risk Assessment, you have to go back again to the international… back to… when was it, a couple weeks ago, Sean? The IMDRF and the, MDCG. They define more clearly what the, the SOTA is, and develop the stage of the current technical capacity under the accepted clinical practice based on the relevant consolidated clinical findings in science, technology, and experience.

Your reviewers don't have this. It's up to you to define it for them and explain it in your documentation. they are not, and they do not have the position or the experience to argue it… argue it, period. And if they start arguing the state of the art with you, I'm sorry, that's not their position to do that. Your clinical documentation has it, your clinical reviewers can look at your clinical evaluation and see if it… makes the defense for you. They have a panel of clinical reviewers that are above your clinical reviewers who do have that experience to do it, and it goes above that. The purpose of your clinical evaluation in the state of the art is to benchmark, to compare your device's safety and performance, and set the content for the risk management decisions.

The acceptance of the criteria of the clinical outcomes, your clinical risk analysis, and the justification of the choice is in your clinical claims. what your clinical evidence is not under the MDR, you know, it is not a clinical data for the evaluation to support the assessment as to whether or not your device achieves its, you know… or what it does do, does it achieve the intended purpose safely and effectively? And that's all defined under the MDR Article 61 and Annex, X1 and 5, whatever that is, and whether the evidence is sufficient and robust, and whether it's documented in your clinical evaluation report. So…

So there's a question about the form. If you want to write form in the chat, if you'd like a copy of the form, then… Bette and I can coordinate on sending that out, just right… assessment form, form, something like that. And I will give him your email addresses, and he can… forward that to you. I just want to make sure that everybody gets that. That wants it, and, has the opportunity to connect with him directly. Do we have any?

another… there's another question in the Q&A section, not in the chat, but in the Q&A section. About, have you seen people list the standard without the version in the GSPR? I've never done it that way. Accordingly, I cannot say How feedback would be from an artified body.

But as far as I.

No, the notified parties, I don't think they will… Like it, because… Yeah, for sure, in the test report, it is written. Which version, but usually they want to see that already. We dived opening all the documents to see which version was used. But if someone else…

the annex as part of the MDR, it has to be included, so…

Yeah. I've never tried to… without, but… and I would not suggest to try without.

Thank you. Okay. Well… Let's wrap things up. We're right at the top of the hour. I would like to give, anybody that has any remaining questions an opportunity to unmute themselves and come on and ask the question of Beat. I want to thank him for his, time and effort on putting this together for us. I know some of it was a little dense, at least it was for me, but I'm not, an expert the way that many of you are, and I would like, to say that this has been eye-opening, for me, personally. I don't know if anyone else feels the same.

I'd love to hear your feedback. Feel free to reach out to me directly, with your feedback, and… or to contact Bette. Via LinkedIn, or any other means. If you want to put your email in the chat, maybe people can reach out to you.

units.

And, Yeah, I think that this was, fantastic, so thank you so much, for your time, everyone. Again, next week, we have, let's see, two webinars, one on PMCF, and then we have Michelle and Tiana from, LeanRAQA talking about, warning letter trends, From the FDA, and what we're… what we're… what… what the FDA is… indicating that it cares about in 2026. show, it's a data-driven discussion, but we're looking forward to that, and I hope that you all, all participate, and help share, the information.

Thank you so much. Bear, do you wanna… Sign off.

Well, thank you, and Ola, thank you for all this, Emojis popping up on my screen and in the chat, and it was a pleasure to be here, and… Moving forward for the next week. Be here again.

Thank you so much. Thank you, everyone. Take care.

Take care. Bye.

Right.

Bye.