 Welcome to the English translation of why the Corten is not a medical product by Phil, live from the 336 KS Communication Congress in Leipzig. Your trendset is for this talk, Alutik and... Duckman. Thanks for allowing me to present something here, to give a talk here, or to say something about my person. I was announced as Phil, that's right. I've worked for over 10 years in the medical industry production, and I can understand if it is not very interesting for everyone, but I like it. I will bring a lot of examples. It means laws are very precise, and this will be a bit diluted with examples. Some things are extremely simplified, because I don't have enough time, don't take everything word by word, but just as in first approximation. More is not possible here due to the time. So first question, it's around who knows what cardio is, who has the one? Okay. Good. Ben, I'll briefly explain something about the hardware. The cardio, I still have a picture from the homepage. It is the standard organizations would say wearable, so you can wear it at your worst. You can use it at home, and mostly it has a lot of diodes, blinks, a rotation motor, so at the first glance it's not a medical product. What you can see at the picture is large metal pieces where you can measure ECGs, where it's the first point where it kind of looks like a medical product. So that's the first step where everyone has to go through. Your product is a medical device, is regulated via the European regulation and the medical device regulation, which is valid in a lot of the European Union. I want you to read the article two of the medical device is what you can see here. So it's a medical device or software that according to the producer has one or several of the following medical and purposes. The important purposes are for the ECG is that it has a purpose of diagnosis or surveillance or something similar. So it could be that similar sensors are in a different product, which where the producer says that the manufacturer says that it is not a medical device, for example in smartphones, and then the manufacturer has to look for what has to be done. So that answers the question how it is with the card here, you're great. So the purpose of the manufacturer regulates exactly this. So the purpose has to be in the manual, maybe you can find it on the web page, you can have an ECG here, nice, that's something which looks like it. And then there's like a long text which describes how you can do something with the data from the ECG. I did this, looked like this, and what's the purpose? I didn't find anything which was supposed to be for indication, nothing for measurements of ECGs, I don't know which diseases are supposed to be diagnosed or surveilled, I know anything about users or patients so it doesn't have a purpose, official purpose so it's not a medical device, that's my judgment. So let's look further. We could play the game and make part of the cardio to a medical device, easiest thing would be to make the program which shows the ECG to a medical device, medical device needed purpose and this could be the start of the purpose, so the ECG app, so piece of software is made into a medical device by describing how it works, what you can do with it, what is a medical reason for using it, in this case if there is a regular sinus rhythm, a sinusism, or if there is an atrial fibrelation present, this should be possible with the cardio, I have two electrodes, so medically speaking I have a cross section through the heart so I can illustrate, larger ECG has several electrodes which correspond to different cross sections, this is not possible with the cardio, second point is where is it supposed to be applied, so describing the environment, next point is who is supposed to use it and who is not supposed to use it, that's what this has to be answered by medical professionals and this is how you could write an official purpose for the ECG app, so to summarize function and indication, the patient group and the contraindication, this is an official purpose of the parts you need, so we have no purpose, so what next, so according to the purpose we can classify as a product according to a law, the classification rules are in the law, I always try to write down which article or annex has the rules, I'll show you now, the classifications are as follows, from a technical point of view it's not invasive so it's not this, it's not an invasive product, there are special rules but it is an active product and so rule 10 applies in this case, which is called diagnosis and surveillance, I want to show as an example the rule 10, so products of rule 10 are products of class 2, so then there are additional things which are applicable but not very interesting for the cardio and the red part here is an important part, control of vital body functions and if you are part of this category then you are class 2b which would apply to the cardio, so that's my opinion, now we have a purpose, now we have a classification and how to proceed, the classification determines how you can bring it into the market, the higher the classification the more you have to do, for example products of class 1, there's no risk, you don't have to do much like Band-Aid is class 1, every thermometer is a class 1 product, class 2a is more interesting, where's the risk in applications, for example dental implants, devices happening here, class 2b, a bit more can happen, where the products are more invasive, for example dialysis devices, endoscopes, condoms, perception and then class 3, that's a real thing that's implemented, it's hard, that's hard catheters, pacemakers, ADs with a significant risk that far exceeds class 2b, so we classify these and what do we have to do with this and I'm going to shine a light on what's supposed to happen here from left to right, so for every products we have to have a quality management system, products of class 1 can do it an easier way, but basically every single product has to have this, another thing every product has to have is technical documentation, in which you record what happened during development, every little thing, next step is not co-writing, the audit by a designated person, you don't have to do that for class 1, but you have to do that for all other classes, that designated person does not assume any risk, but this ensures that a neutral party is involved, for class 3 products there is a special product testing, there of course the ones with the highest risk, then there is the CE certificate and they basically tell you yes your product conforms to the CE regulations so you are allowed to put the logo on it, in the next step a unique device identifier needs to be attached to the product, it has to be registered, it has to be both on the product and on the packaging, last step is not co-writing again, last step is upkeep of this whole quality management system and all the processes, okay let's have a look at this example what you have to do for class 2 product, so a quality management system is required by law and industry has determined that the letter of the law is a bit difficult and can be interpreted, so that's not always that easy, so audits are expensive, so what happened? Norms, standards, standards have many good sites, there is less room for interpretation, they are a lot clearer than a law, they are internationally recognized, so if I go into one country I can use the same norm piece of paper in the next country and that overall makes for an easier audit which means cheaper, hence almost everyone uses the standard, then there's the expectation of standards, it's in the agreement and if I conform to certain parts of certain war norms I also conform to certain parts of some laws so it doesn't have to be checked for conformity with law, that's just automatic, I actually don't remember this slide that much, so a quick explanation what categories of standards are there, there's three main categories, there's general, that's often process standards, then there are standards for electronic technology and telecommunications, electronic technology means everything with a plug, telecommunications means everything that has a radio, in Germany there's three organizations that do this, that's the dean for general stuff, Dean Afia is a standard paper size and then there's DKE, VDE and Dean for the other two categories, Europe we have Ser, who do the general norms and electrical stuff and then we have Etsy for all the radio and telecom standards, internationally we have the ISO which does most of the process norms, the IEC which does the technical stuff and the ITU which works on worldwide telecom standards and let's take a look back to where we stopped, we stopped at the QM system, here's our first achievement, we have the ISO 3485 QM systems, so this is the first standard that is relevant for our medical product, roughly it looks like this, it's highly impressive, it's very large actually and the significant part of this is the business standards, you have your quality policy, you have to have a quality management handbook, there has to be an overview of the company, of the process in the company, what processes do you have, it's a top-down look, in the standard it says that the highest executive of the company has to have this as their job, the employees are not allowed to do this, it has to be the leadership of the company itself and this is subdivided and subdivided into smaller aspects and it goes down to various other documents, it can basically be everything, it's a hierarchical top-down system, in the QM systems a lot of things are very well defined so please look impressed, this is the sort of thing you find in a QM system, they basically want a process for every possible eventuality, if you want to do this yourself, don't be too impressed, the hot topic is risk-based, we looked at the most important things, did our assessments and now we're starting what's very critical, the designated persons know this, they have their guidance for it that they have to obey for the audits, you can get better bit by bit and there's development, the next standard is ISO 14971, it's a standard for risk management so I'll have to have a quick look or rather explain what kind of steps there are that you have to perform, the first step is what did I write down the edge cases, you have to determine what are the functions of the device, what risks are derived from these functions, though the standard says threats, threats are defined as a potential source of damage and these threats you have to, from the ones that can happen you can have go to risk situation, so the lamp at the ceiling can fall down but as long it's a hazard but as long as no one's underneath it, it's not a hazardous situation, only if people are close to it there is a hazardous situation, from this situation you have to go to risk, risk is defined to be the combination of probability of a hazardous situation happening and the resulting damage, these two values you can write down on a matrix and determine parts which are where you say it's completely unacceptable and other parts where you say it's why it's not acceptable but we'll leave it for now because the use of the product, the advantages of the product are more important and that's what's written down here, next step is the risk evaluation, where you say I've identified my risks, I moved from hazards to risk, I have my graph, how many risks do I have that are acceptable or unacceptable, this whole process is a risk evaluation, next step is risk control, where you want to have functions which reduce the risks, first one is modifying the design, where you change the product in such a way that it is not technically possible for the risk to occur for the ECG that's not really possible, it's a product something that creates a lot of heat, you can maybe change it, where you take induction instead of gas to reduce the risk of someone burning their finger, if that doesn't work you have to implement protections where you can move the probability but the risk still is there, the third possibility is to inform people or school people and at the end of risk control and more is not possible, next step is risk acceptance, you sum up all the risk and look at after minimizing the risk, is it acceptable, this is also the case, you write it down in the risk report and in the last step the last step, did what you write down work out or did you totally estimate something wrong or other new risks and this is also part of the process, next nor a standard that is applicable as i.e. 82 304 about health software, so let's look into this, the standards are from a time where no one could imagine that software is an independent medical device, basically all standards were written by people who were very much focused on hardware and mechanics so you will see a lot of V models or waterfall models and that's also how this norm starts, this is a lid because you forgot to classify software as a medical device, so now you say you've done everything for software, nice but don't ignore the whole environment where the software will live and so you have the system requirements then next step is the life cycle and determined in the ic 62 304 then you have to verify the system requirement and on top of that you have the validation and there these are two terms which have to be differentiated, verification is objective tests that certain steps are objectively verifiable, so for example you can put a ruler next to it and you say yeah that's inside the error tolerance and validation is defined that specified users, a specified product in this specified environment can use, people can use this product so you can very verify the product but people can't work with it because it's for example if it's too dark and people can't see anything that's here the standard adds a validation on top of the verification, additional you have some byproducts like some files which have to be created which comes in via the hardware products like the manual for the hardware or other stuff and there's also a last step where you have to keep up with and we have the next standard that we mentioned already is ic 62 304 that's pure software norm as standard it was developed in a time when people thought that software is always part of a medical software product but then there were medical products whose software was so bad that their own standard had to be invented a good example is the therac 25 a radiotherapy machine which didn't quite work and literally burned the patients on the table so much radiation was dumped into the body that the people ran away screaming and that's how this standard happened and standard starts at the beginning and says so you want to develop software okay but you have to plan it you can't just start developing but you have to think about what you want to do this starts with the software standards goes you have an architecture implementation verification the standard says plan all this in the beginning how the integration is supposed to happen and don't just start coding the next thing is the expectations at the software how do they have to look what do you have in their software architecture and the standard says i identifies or it identifies software systems so everything that has its own processor is on cpu dsp fpga is a software system you have to identify those break your software architecture down into a detailed design here software items and software units are mentioned so a software system breaks down into software items and software items break down into software units and that's the end of it the exact change in the definition between software item and unit is that with a software item the person making it says i can't take this apart any further if you go all the way down you end up an assembler you can do that but most manufacturers say yeah this library it's made of a lot of stuff and you can't really take it apart so they have the freedom to basically do what they think is right at this level the whole thing has to be implemented and the standard says you have to obey these things first you have to verify your design then you have to integrate your architecture just like you planned in the beginning then you have to verify the expectations and then the software is released here too we have certain things that are general that have to be done at every level then there's a software repair or patching so it says you have something on the market but what do you do when something doesn't work like it's supposed to there's software configuration which means what deliverables or what tools are you using is there a verging system is git happening is there's a branching workflow all this is defined here do you have an integration server if yes what do you do with it how do you update it how do you manage that all this has to be done and these processes are exactly for that then there's the process for solving problems in your software so what has to happen to change to changes what steps do those changes have to go through so let's have a look should actually ah yes nice and there's the next standard ic 6236x that's the one about as they say in german gebrauchstauglichkeit in english it's usability usability subdivides into in multiple parts the core thing is you can't sprinkle usability on top at the end but you have to keep the concept of mind from the beginning so there's a development process for this that starts in the beginning and at the end you have to evaluate it the standard talks about formative and summative formative is what you what happens during development and summative is what happens at the end then here too you have to look at the purpose so define the users define the environment what can be done with this thing how does this thing work so everything every single norm involves these factors in some way they at least have to be described then usability has to be specified in the simplest possible case this is more or less a style guide that says our product is constructed like this this is how you operate it we use this and that design this arrangement these design patterns and these have to then again be verified so best case i can use automated checks do these elements exist where they're supposed to be where we define they would be at the beginning or do the menus change like the design guide says they're supposed to just like everything has to be verified it has to be validated so i have to get real users and check if they can actually work with this stuff ideally during development so then we have iso 15223 this is about symbols and such this is one of the cheapest this is not an error just a thousand bucks the standard itself is a lot cheaper again but you just have to know where the symbols are supposed to go the nice thing about this one is that it is only for medical tech but the iso is so nice that the symbols in general can be viewed at their home page so you go to the iso page don't look for medtech but look for iso 7000 and then you can move through the iso home page and at the end you're going to land at the or the preview symbols which can be used here and you can click on them you'll get them in big you got them digital and you can just put them in the documents where they need to go that's actually kind of neat at the end i'd like to say that the purpose or the definition of purpose is the important bit of text a lot of stuff is determined here if you don't start with this keystone properly at the beginning you're gonna have immense problems as soon as external audits happen so in my case i said yeah cardio yeah nice awesome but it's just the software on the device if it was the whole thing then the whole hardware would be a medical product and we'd be in a whole another area we'd have to have the 6061 one standard and a lot of other regulations so reach rose vmv that's electro electromagnetic compatibility bio compatibility radio norms shake tests so yeah if you can avoid this that's a good thing and it's good thing for the maker of the product too exactly how it is represented development models because a lot of manufacturers are hardware manufacturers they only know this v model which is one of the most established models in the medical manufacture for me from a medical manufacturers there are a lot of companies who do this what turned out to be is that you still require usability but as soon as you have those you say we have our crumb project a process we are in a regular grid we are in a regulated market we can say that at the end of every spring there have to be concrete documents and during the process i can take documents from from the folder and can do design your verification and go up step by step and in an agile process i can go go through many these and that's what's happening usually in the industry and a lot of different things i also haven't seen a lot of different things things there that's what i just know the model is very important people don't know anything different what doesn't exist yet our standards for security and safety there are guidances the bsi is part of the standard of the committees of creating the standards it's a funny thing if i'm if i'm part of this i'm i'm called young because i reduce the average the the age average by 25 years um so they just don't think about the topics like this um there will probably be new two or three new standards less next year but at the moment there's nothing and the manufacturers don't really care about that now much at the moment the manufacturers and the the users uh fired a lot um manufacturers say oh yeah you have these great devices can a lot of do can do a lot of fancy thing in the networks and say to the user the the user has to take care of other security because the manufacturer said that's not my department we will not take care of that um we'll see how that turns out now we are done with the development so now is the noted body um comes in and does the audit first they want to see the documentation um depending how much they want to see depends on the classification next thing is the audit of the 13485 way and if you pass you get a certificate and then there's another certificate which by law allows you to put certain things on the market and you then declare the conformity that's very important in the EU there is no um there is no admission by the state um in in the US you go to the FDA and they admit your product or approve your product in Europe you do this yourself um this is written in the mdr nx4 um in nx1 it says um in nx4 it says do all this stuff written in nx1 which is like basic security um demands um in nx2 is technical documentation and in third step is surveillance of putting the process of putting on the market um a lot of manufacturers already have this but now it's also written in law then we can explain the conformity with a conformity explication which has to be a formal document with specific things in them what's the company where do you find it you have to have unique numbers with you have to name the product uniquely you have to have the risk class the noted body for products from the class to a to b and three and last thing is a date and this has to be signed so that's one of the few documents where you really have a formal uh heavily process if this is done that's great um then nx5 you get a c e um certificate which is exactly what it means uh means that you have declared to conformity that it is safe according to the noted body and the manufacturer and underneath you have the number of the noted body in this case zero one two three depending on where you go you might have a different number there so next step you have to register the udi is a unique device identifier this has to be not only on the product but also on the fabric um to to talk about this um which um which costs too much time but i want to talk about this very briefly there are two parts the udi di and the udi pi the di is static static part which identifies the device the the company this is a part that is more less static and then there's a second part which is dynamic um when was produced the lot number um until when is it usable um so this number depends on how much you want to put on the market or how much you how much you want to produce if you register the udi you manage to complete the development process and can go to the last step um the next step is chapter seven um surveillance and vigilance and these sort of topics upkeep means you have to renew the certificates they all come with the best buy date and i believe even the declaration of conformity has one and uh well let's have a look uh yeah it worked so you have to have continual uh audits uh the audits may be surprise audits uh you can as a maker of the device you can audit your the people you buy the parts from uh and you can be audited yourself there's a video from a french company that is both in the role of a device manufacturer and a component manufacturer they had about 20 audits in a year and uh well a noted body had a look at us the makers who we develop parts for okay and we basically just use the same piece of paper over and over these audits are a highly formal process and well usually you have a so-called front room backroom setting which means that there is one room where you go with the auditor and the auditor never leaves this room if the auditor wants to see something he asks what's the purpose of this thing and then just sort of digs through the paperwork backroom listens via skype or any other form of audio and will on demand if it's a paper based system literally stand next to the printer make copies that are marked as such and bring them to the front room and say here my dear auditor you wanted this let's see if you like it in digital systems this is a lot simpler but this is a typical setting and that you sort of disconnect these areas okay so these processes belong to the quality management system so you need one for market surveillance for product changes and for continuous improvement or for kappas corrective and preventive actions and yeah with that i'm actually done that was one whole product development and upkeep in very rough steps i got a podcast if there are any questions thank you so we have time for questions we have three microphones number one two and three please just go to one of them if you have questions and i'll point at you we haven't got anything from the internet yet something may be coming but microphone two hello with many slides you can replace the head a heading medical technology with automotive or aerospace technology it's basically the same the only way the standards are different is by the number but it's basically the same talk quality management risk management and so on is there something in medtech that deviates significantly from critical systems in other areas from the requirements not really every regulated part has certain things that have to be regulated what's special about medical devices is like appliance always kind of similarly constructed to for medical devices for the process this has to be has to work from and band aid up to devices implemented in your heart and representing this complexity is very difficult because no producer really finds himself or represented and that's a difficult part in for medical devices but the requirements are the same for all regulated areas okay just a short comment the whole thing about software that's sort of tacked on at the end as an afterthought and how the standards were written based on hardware it's their way in every area i know this is from aerospace technology where you rather change five hardware devices before you touch the software it's not that bad in medical for medical devices okay mic one please hey thank you um this all sounds quite complicated and for me the question emerges that what is the standard and what actually forces me to treat my device as a medical product where's the law where's the initiative that makes me not say yeah i'll just forget the certification it's too complicated the pragmatic answer to this question is if there are companies which compete with you they will sue you and what happened then that it will be come in front of court and then the the um someone appointed by the judge will do the the job and if it is obvious if it's if it's obvious um for some devices you can um if you it's supposed to be applied to a heart for a patient which is alive you can't really argue about it um you really should think about if um that you really don't aren't part of this classification otherwise you get the purpose report um really have to read the report um but uh i mentioned earlier where's the differential what's written what's different from pharmacology and okay mic two i have a small smartwatch here that has an ecg but in europe it's deactivated like from many other manufacturers we've just seen a well-defined process for doing this so why don't big companies like samsung or apple why aren't they able to do this sort of thing the apple watch is a great example it is at the moment in europe um a medical device not even the apple watch but they did the same trick they have they declared two apps as medical device one is the ecg app which has more or less the same purpose as we saw here and the other thing it is the app i think it was um detection if you if you fall um and those two things are medical devices and not more and for these two things you can find a purpose declaration and you can find the ce symbol and if you look at this you will see exactly what we saw here with number zero one two three where the tooth suit was part of the conformity um process meaning that it is at least plus two a product um and with the whole but it was a whole hardware apple set itself it does make sense the hardware so the main goal of the of the apple watch is not medical device everyone supposed to to develop for the apple watch they can't and don't want to control it and and so they said for these two parts we keep our our independence and only for these two things we have medical device status okay i was interested in why the hell this takes so long the apple watch took months to get certified that's right in this case apple is a u.s company they made the first application at the fda they knew exactly what they had to do and fda is a government organization was strict processes and it is easier to predict predict when they get the clearance from fda you have in europe you don't have this clear process you only have the guidelines and along which you can orient yourself the tooth suit can say oh well that's what the fda said but we have another standard here we find applicable so you have to you have to give us documents that you fulfill this and then apple has to live and the fda is not that much standard driven it's law driven and that's why i think apple it took longer for apple because they went look at the problem from a different mind that because they are american okay let's switch over to the internet yeah short question from the internet uh how much do those independent audience audits by uh name party cost it's like this and the producer looks for a noted body like for example europe a noted body from europe and they pay money to this body and this body performs the audits that's kind of an interest of conflict but the noted bodies um are very loudly saying that we get the money from the company but we can prove on paper that we follow the procedures and didn't just let any shit get through and there was some critique of some noted body but they were able to show that they showed that they did everything they possibly could but they can't but that they can't protect themselves against crimes okay mic one uh so uh in developing medical products a lot of documentation is generated is there any way for the patient or for the user of the document of the medical products to get their hands on this technical documentation no it's not possible we are at the moment at the moment so our changing at the moment we have an odd law the mdd which is still valid until may next year and afterwards the mdr is valid and afterwards there is a european database which is not completely public but partially at least um but the company say that's our business secret um that's the core of our company we can't just make this public the law says that certain things has to be in the manual that certain things have to be noted the uda or the certificates that's legislate um that has to be on the product but not the documentation um you could try to write a frame of information egg at the fda to get the documents but the fda will say if you do this once no one will ever come back to us um so no it's not possible to get the documents but only the the documents um for the users okay mic two yeah thanks for the talk and i've seen it very often that very small companies do algorithms to ctr mri images generate new images from that analyze them and say oh we're not a medical product we're just doing this for scientific purposes and then we're if you dear doctor use this data clinically then you're doing it for yourself because you're making the decision with the data you received from us is that legitimate in any way shape or form is this doable for small open source parks that want to do things with images that's gray area the manufacturer says this is only for clinical research this is only to test something and then you use it for something else the manufacturer will say the user is responsible if it's happening in a larger context the noted body or or a government organization will step in and stop it and then we'll go in front of court and then someone um appointed by the the court will write documentation another thing is that there is also software for example radiology um where this doesn't happen anymore um if a manufacturer just goes there and says you ever radiating um device and then takes the software from a small company and then looks where it has to shoot through the body that's not going to happen and with other cases uh possible but it's the question if that's happening though let's go over to number one uh yeah my question shorter follows this one how is standard adherence actually enforced so if doctors use the cardio on patients to surveil something or flower power enterprise some products whatever um use that stuff because it's cheaper who would realize this when how and where and what would be done about it i mean you can't do anything about it if someone uses the cardio like a medical product what can be done about this and who would get hit easiest way is to go by the farm that's uh um organization government organization germany responsible for a medical product where you can um complain and they'll take care of it and of course from time to time they have a lot of to do but that's the first um organization you have to contract so who would actually get punished a doctor uses cardio as a medical product without it actually being one will someone decide that cardio actually is a medical device and cardio whatever problem or would the doc have a problem um that's what a assessor has to um determine that's what comes out in front of court um if it's not a medical product and can't and detect and diagnose any illnesses which is according to my opinion true at the moment then the manufacturer will be liable because they used something the product which is not doesn't have the the um the the purpose um the device says you exactly when happens what um in this case the manufacturer is also um reliable but this doesn't happen for the cardio this all depends on the purpose of the device so you have to kind of guess what will be written in the report by an assessor got anything from the internet no well okay then we'll do mic one please hello if i understood it correctly then apple said that the apple watch is primarily not a medical device um it has other purposes than measuring vital parameters i don't know the product cardio personally but does the hardware have any other purpose except medical ish things oh okay so how did you get out of that bind because just from this talk it sounds like the thing is primarily for medical purposes okay i highlighted the medical part because that's where i'm expert in um the cardio on itself can apart from a thousand other things also create an ecg but can only visualize it not very well as schneider i'm sorry the thing can or should be used for much more than the ecg um where i'd say that people are supposed to write software it should be accessible should somehow connect with other cardio's and you should be you should write um create fancy things for the display you should um write the settings if you want to talk with other people or or not um it has to blink and that's where i start where i'd say the ecg is also part of it but it's also it's also just a toy it's not what the cardio is um supposed to be well i believe from the talk there it was only usable for this one thing but yeah that's a good answer thank you and we're going to continue with mic one good evening i have two smaller questions first one is uh could it happen that's something like google scholar pod med that docs use uh every day uh to make decisions about their patients could it be that that is a medical product by law and secondly the uh the difference between uh cat 2b and category three is a uh life threatening or very dangerous decision in software at least it looks like that to me in medicine it looks like patients can easily develop allergies to everyday medications penicillin for example and could die from those so how how is it that with that even banalities can have devastating effects in medicine and how that a small tiny product should essentially be built to the same standards as a robot who operates on my heart second question i can answer rather easily this has to do with the classification rules i only presented the rule 10 and for this product for each product you have you need to know the function the purpose and then you can go through the rules and they're just explained exactly if you have a product which has specific features if it has a specific invisibility uh then you land in specific categories other to show other rules here it would be very hard so it's kind of difficult um for the first question we have to meet uh in private um yeah we're talking about google or pub matter up to date um i don't really know what they do so i can't say much about it i'm sorry okay we're out of time and no more problems so thank you very much thank you