Medical Device News – September 2021 Update

Medical Device News – September 2021 Update

welcome to the medical device made easy podcast here is munir aladouzi from easymedicaldevice.com and today we’ll talk about the september update so first we’ll go on the hot topics for what happens mainly with a lot of countries in the european union outside we’ll also go to some key events that will happen this month so september and october we’ll also mention the situation regarding notified bodies then about the guidances so ndcg guidance primarily and at the end we look at what happened within easy medical device so uh let’s go first this information about fda so in the us there is a complete shift in terms of the regulation for some specific products so those products were drugs before and now they will have to move to devices and this will maybe change the entire industry so it’s important to to listen about that so um this is mainly an fda so fda lost a court battle against genius uh so mainly the the objective was uh regarding genus to change the regulation for the contrast imaging agents they are regulating the us as a drug but apparently they are also meeting the definition of a medical device then the um mainly the the court said that as it’s meeting the medical device definition it should be registered as a medical device and not as a drug so if you have some devices that are drug and devices at the same time you have root to define which one is the is the most important for them so mainly this is uh here the device that is winning and the rule is mainly that um if you have some kind of chemical actions within or on the body so then it will be a device it’s more if it’s more dependent upon a metabolized product so then it will be maybe more considered as a drug so fda is now planning to transition those products so they are trying also to define a list of products that are impacted by that and they will communicate that list they will also try what they are saying mainly they will also try to make it easy for all the manufacturers to transition to not have any disruption on the market so you can go on the shoulders to read the article about about that then we move to germany so germany uh is alerting us that there is a potential issue of building a vulnerability related some some real-time operating systems so it’s interesting because this is an alert coming from the us mainly um so um the u.s agency so the cyber security and infrastructure service agency um emitted an alert and apparently only b farm in europe just alerted about that so this is mainly some um some devices that are using some of those uh real-time operating system uh like uh qnx or vx of works but there is a full list of those systems that are on the on the b farm notification and you can have that under on the show notes so there is apparently some critical vulnerability in the system and the medical device manufacturers will have to issue to make some some updates and if one of those issues is really impacting the market they will have to issue an f a field safety corrective action and inform the bee farm about that the question is why this is only b farm with informing about that this should be mainly european all europe should talk about that um because mainly it’s not only in germany that we have some some um some manufacturers that are using those systems so i’m alerting go to this notification from g farm uh it’s in english and you can just look specifically at the operating system and if you see that you are using one of those real uh real time operating system then please check if there is an evolutionary ability for you if there is any correction to do and also inform your earth authority if there is any field safety corrective action so i think it’s important so yeah i also maybe if the eu commission is listening to that so maybe it would be great also that these issues that are discovered locally and informed locally can also be raised at the european uh union uh because mainly this is not impacting just one country it’s really impacting the european union so france is anticipating some disruptions of products on the market some medical device products on the markets and they have issued a new procedure for those companies that are seeing that there will be some issues they are mainly having a procedure that will be applied from september 1st 2021 mainly there is some preventive action that you have to do you have to check i mean they are also already i think say be careful of your stocks and be sure that everything is fine but they are mainly talking about products that are really essential uh to the healthcare system so mainly um there is no definition so what is an essential product maybe something that is maybe defined by them but then they are alerting and saying if you have any description so alert us and they have defined a decision tree they have defined also some form that they have to fill so many it’s it’s targeted to the kind of purchasing or departments that are the ones that are buying products for example from health healthcare facilities or from manufacturers that are also maybe aware of these disruptions on the market so um everything is in french i didn’t find uh i didn’t find there is a anything in english but if you are french if you are in france and you are selling your products in france if you see that you have any description of the market of your products on the market then please go it’s also on the show notes go to the link on the show notes you’ll have the process you have the forms you have the decision trees that you have to to go through so this is applicable from september 1st 2021. okay so let now let’s talk about finland so finland has created some medical act so to supplement the mgr and ivdr where we are talking mainly about some specific situation inside finland in finland because in the mdr there are some areas of it that says it is upon the national authority to decide some of those aspects and in this in this medical act so finland is deciding on some of the elements that are um in a question mark on the mdr so many for example they are talking about registration of obligations of economic operators about the fact that in finland uh disposable devices cannot be reprocessed or reused in finland so this was also something that was uh published as a as a as a as a common specification by the european uh union which says mainly that um the national authorities can decide freely if a product that is disposable can be reused reprocessed after making some studies by the healthcare facility et cetera so finland says no disposable it’s disposable so we are not authorizing our healthcare facilities to decide and to then move to uh reprocessing some disposable devices so you have also here uh some information about the operator supervisor supervisory fees you have the language requirements so apparently finnish swedish and english is authorized but if there is some alerts on your device some issues some warnings this should not be in english so this is mainly something that is mentioned there so if you are selling your products in finland then please read that because it’s mentioning a lot of important things for you and he’s also talking about ivdr so many uh the magical axes also there is a second medical act also talking about ivdr and here the elements that are mentioned there are partially available because mainly m ivdr will be in place by may 26 2022 so uh this is something that they are anticipating maybe there will be some updates also after that but if you are selling your products in finland these are some medical acts that you have to read to understand exactly what are the rules for mdr and ivdr in finland okay now let’s go to the uk so uk they have made a small update about their way to do uh yeah free sales certificates for the exports so to issue a free sales certificate um so mainly what i wanted to mention here is the fact that um yeah there are some ways or some rules related to the ordering of free sales certificates i take this example of uk but this is mainly also for all the european union where only a uk based manufacturer a uk responsible person or authorized representative in europe or here in the uk a northern ireland based authorized representative can order a free sales certificate uh so this costs in the uk for example 75 pounds uh up to 10 for to take and it can take 10 days working days to get that so um as i’ve said it’s nearly the same in all the european union i had a lot of calls from companies importers distributors outside of the european union that are saying okay can you help us to get a free sales certificate we are selling our products in mexico in germany in argentina or in asia or whatever and they say but the authorities wants to see a free sales certificate from europe which makes it makes it easier for them than to sell their products and the point is i am not the authorized representative for the manufacturers that are delivering those products in europe uh i am yeah so this is not possible for me to order a free sales certificate uh unless there is maybe some special rules in some countries but in the countries i’m working with so each time you look at the designation they say are you a manufacturer or the authorized representative uh maybe some are asking for importer directly but me as a person that is not on this logistic area i cannot do that so it’s the same here if you are in need of a free cell certificate go directly to if you’re an importer and distributor in a certain country country go directly to your manufacturer they have to initiate that or this manufacturer will contact its authorized representative to initiate that so uh this is also something that is really important for you to understand so that you understand how if if your business can work i can say with with widow without these free sales certificates and then we go to switzerland now so switzerland uh we are still in switzerland there is still no contract or agreement uh under the between europe and switzerland so we still consider switzerland as a third party country and the swiss medic has issued a guidance to explain how what is the role of a swiss representative importer distributor healthcare facility etc so it’s really well explained inside what are their role and responsibility what they can do and not do etcetera so this is i think a document is really important if you are becoming a swiss authorized representative also if you are an importer so remember that it’s the same as in the european union as soon as you are selling the products in switzerland for example i mean in that case switzerland uh you need an authorized representative and you need an importer so it’s not like you are just appointing an authorized representative and you are in a good shape no you are also appointing uh uh or designating a uh an importer that will be taking the responsibility of the importer there is no need of a designation for the importer is just the fact that you have to have one and this importer has also to register within the within swiss medic so as the authorized representative the importer should also register within swiss medic so this guidance is really interesting so you can go there and check exactly what are the roles and responsibilities so that you are really understanding there is an faq frequently asked question at the end so that you can also see some specific question that people are asking to them uh so i think yeah it’s really a good document and i would really recommend to to look at that if you have any question about swiss representative importer or distributor in switzerland okay so uh just to transition on that so easy medical device now is also able to help you as a uk representative so we have done that following the brexit then as a swiss representative because our office is in switzerland so we are helping also a lot of manufacturers to move their products to switzerland i mean not to move they were already selling their produce to switzerland and now they need to appoint a a swiss representative then recently we also registered our company for the european union in belgium so uh we have we are registered also in uh udamed so if you need also a european author representative then you can also contact us so the idea here is that uh for me the objective was many to serve the customers that we are working with in case they have a need to be represented in some of those countries and the idea is also that in case one of the customer wants to go to the three markets then we can make some kind of discounts or helping them related to that and not having to um to uh to charge them the registration fees or the review of technical file fees when mainly we can review it once for the three countries so don’t hesitate then if you need our support for that so don’t hesitate to contact us the emails will be also on the show notes but the main email is info at easymedicaldevice.com info info at easymedicaldevice.com and then we’ll transition we’ll transfer that to the the person that is in charge of each of the regions okay so i think i hope that this would be really helpful for you and in case you need another service that you say okay uh we need also this kind of service please let me know because i’m always trying to find a way to help you to find a way to create some services that will be necessary for you in europe so don’t hesitate to uh to also send me an email at info at medical evidence.com and just suggest me say oh i will need this i will need that and if there is enough customers that are asking for that we’ll maybe try to find a way to create this this service for you so the season of events is opening now so we have a lot of events that will come and i’m participating to four events within the month of september and october and i wanted just to share that with you so first we have the gcc uh event so gcc medtech which is uh the middle east event that is happening it’s a virtual event where we’ll talk a lot about all the regulatory regulations uh quality regulations aspects there is a good speakers will have some uh some panel discussions uh so uh don’t step to go so the dates are from september 20th to september 22nd so three days where you will have a lot of content related to quality and regulatory affairs so don’t step to go on the show notes to the um to the to check the email address so www.gccmedtech.com so all attached then um there is an event that i am um co-working with uh for the for the creation so mainly uh it’s a an event that i’m uh i’m doing with the jack wong uh may from uh i am so from arpa uh that uh we are really working on on this this kind of event so we are trying to make it uh convenient because it’s the first time it will be in the european union so we have made it on september 28th and 29th morning only so that also the asia part can be part of be part of it so uh go also to the show notes to see the agenda we have some good speakers there uh we have eric well break we have a basil acro that will also speak there martin vite from chief pseudo so we speak so i try to really have some good good speakers so that we can uh give you a an event with uh some updated information related to mdr and also ivdr so those is that to go there also then we have a french one so we have in france so a school so a biomedical engineering school which is called ecfc institute superior the degenerate of france so it’s a school that is located in buzansson and they have also created an event that starts to be really well known in france and and really frank french regions so many it’s called andre judem which will be happening october 6th and 7th and i will also be part of it uh so if you are there so don’t hesitate to meet me uh we will be really happy to uh to discuss with you uh so uh and i thank also uh florent who is the one that uh that invited me to this event and i will see yeah if i can really we can really have some good sessions there so don’t hesitate to join us and the link is also um uh in in the show notes uh and the date also so october 6th and 7th then the last one will be the medtech virtual summit uh which will be happening in october 18th and 22nd uh where we’ll also discuss i mean a lot of good speakers are also going there so just look at the agenda look at the program that is there so um mainly all those um events will be there in the show notes uh so for those events i will be speaking um if you want to see my my the talk that i will do uh be providing so go to the links but mainly yeah we’ll really talk about all the new updates we’ll talk about brexit to exit uh we’ll talk about a lot of things related to regulatory compliance so um i think it will be really a good event and good updates also for you so don’t hesitate to join us okay our favorite topic now so notified bodies so we had a new notified body that was uh accredited not for mdr but for ivdr which is gmat so gmail is already appointed for mdr but now recently they were appointed for ivdr which is good so now we have 22 notified bodies for mdr and six for ivdr i remember yeah recently it was like four then five now six so i hope there will be more because as we’ve said so ivdr is coming soon so the 26th of may 2022 uh then uh a lot nearly 90 95 let’s say of the products are transitioning from self-certification to notified body certification so it’s really huge so it means that nearly all companies that are delivering in vitro diagnostic products will have to have a notified body uh so you have you cannot yeah you cannot go away from that so and nearly uh there is no transition period because mainly if you go from certificate to uh to uh to uh this so many it’s immediate from the 26th of may 2022 so please um yeah move forward with that try to have your notified bodies try to have your certifications so that mainly you are ready for the 26th of may 2022. okay let’s go now to guidances so we had three mdcg guidance that were released this month um in the month of august uh so the first is the mdcg 2021-21 which is a guidance on the performance evaluation of sask of to cov2 in vitro diagnostic medical devices so um as they mentioned inside this mdcg guidance this guidance is the basis for the common specification related to uh the for the ivdr so mainly this is something that is really important to take into account because when the command specification will be published mainly to be based on this mdcg guidance and here mainly we are talking about a lot of aspect parameters related uh the the the caliph qualification and of the of the sask of two uh in vitro diagnostic product so here the overall consideration are on sensitivity and specificity on interference and cross reactivity on anticoagulation anticoagulant verification on the batch testing criteria so there will be also a lot of tables that are um mentioned there where more uh more information for each type of products so if you are in this business of having some tests for uh covid19 so i think this is something that is really key for you to read because if you want to continue your business after when the ivdr will be in place this is mainly what you have to follow uh for ibdr so this is really important so this is also on the show note go there and just read it the next one is mdcg 2021-22 which is a long test long text this one so a clarification on first certification for that type of device which is in bracket and corresponding procedures to be followed by notified bodies in the context of the consultation of the expert panel referred in article 48 of umdr so um mainly here this guidance is specifically for notified bodies on uh no on ivdr sorry so for notified bodies to decide uh is your class d device does your class d device need to go to an expert panel you know that for performance evaluation you have to go through uh some expert panel uh for reviewing i mean the notified body is reviewing the products and then it has to decide to go to an expert panel and here it says to you that there is two criteria to decide first is there a common specification that is published if the answer is no then the second criteria is where is this the first certification for this product for this type of product um so mainly here it says it helps you to define what are we talking about type of products first time of this type of products etc because maybe you have a similar type of product that was already certified before and this is a new version but nearly the same but it’s not maybe the first time etc so here it’s really clarifying but first if your product has a common specification then you can already say okay it’s fine then no need to go to an expert panel uh if you probably don’t have a common specification then mainly uh if it’s the first certification you’ll have to go to the expert panel but as i said read carefully this uh this guidance so that it gives you exactly the the right definition in terms of what we are talking about here and the last guidance which is an important one which is uh the guidance for notified bodies uh related to distributor and importers for article 16 so yeah i would say a dash four or something like that 16 part four of the umdr and ivdr so mainly what it is so mainly uh you if you are an importer and distributor um if you can be considered as a manufacturer if for example you are changing the name of the device if you are changing the intended purpose of a device if you are changing a device that is already marketed etc so then you can be considered the manufacturer but if you are just translating the information that are provided with the device so one-to-one translation if you are repackaging this also then you are not considered as a manufacturer but you still need to have a notified body that is reviewing your quality management system and verifying that you are doing good with that so um it’s really yeah let’s say strange when you read that because mainly yeah there was this confusion or not confusion but this clarification related to the fact that on the article 16 it says that you have to have a quality management system which should be reviewed by a notified board but the question was can a certification body be sufficient or should it be a notified body here apparently it should be a notified body but now then the question is the fact that a notified body is selected per product so per type of products and here it clarifies that yes if you are distributing pacemakers so your notified body should be qualified for pacemakers then they are coming they are auditing you they are giving you a certificate especially specific to pacemakers etc but if you have another manufacturer another person that is distributing through you but it’s a dental product then um so then they have to have all this notified book that they’re already appointed uh is also qualified for dental products or if it’s not then they have to appoint a second notified body uh which is then uh accreted for dental products so i see here it can be really a nightmare i suppose for some of the importer or distributors because at the end the manufacturer will appoint a notified body to certify its products then the importer will appoint a notified body to have a qualification for his quality management system he has to get also a certificate for that uh which is uh something that is also a new if i can say to this uh this market and if this importer which is an importer so means that you can have multiple clients with multiple products with multiple things then it has to appoint if possible a notified body that has really a big big scope for its product so that any of his client are under the same notified body or otherwise he will have to appoint second one um the advice that i’m giving to importers and distributors and maybe to manufacturers also is try to avoid that by just for the manufacturers by just providing to your importers and distributors products that are already in the right language in the right packaging so that there is no modification at all because then you will yeah help them a lot and it will create less burden for everybody because this is really i suppose by reading this guidance it will be really a big a big burden for every importer or distributors that are doing these activities or of repacking or of translation so if you want to avoid that the manufacturer should take the responsibility to provide to you if you are for example in greece documentation packaging all in greek so that everything will be fine for you instead of you having to translate having to repack and do everything like that so um yeah this is just an advice so i’m not like here doing this kind of thing saying uh that it’s better it’s just an advice if you want to avoid the situation go on that route i mean go on the other route menu okay now let’s let’s go to the easy medical device situation so mainly uh we had a three podcast uh this month the first podcast is um what can we learn from the mdr audit so we had that with the martin vitter from chief suit so martin helped us to understand what kind of issues are happening often during an mdr audit and helping you to solve those issues before the auditor is arriving so here yeah you can go and check that on the show notes episode 141 which is a better to be a consultant or a full-time employee so we had us mahanto gray from uh tech firm who is a consultant who helped us to understand what is the advantage to be a consultant what is the role and responsibility uh how are you welcomed when you arrive to your company when it’s a big company a small company etc etc so this is really something that can help you if you are a full-time employee for example and asking yourself should i go for consulting then maybe this this episode will help you a lot because yes mahan has some experience on that and and she provided really good advice for for you and we have episode 142 which is called how to certify a medical device and we had that with dr atin rad from chief sued so it’s really a complete episode where we talked a lot about software’s medical device we answered a lot of questions that people are asking me nearly every day when they are contacting me about class one is my software still a class one or not uh so you know that a lot of software under mdd were class one and now under mdr they will become class two a uh so the question i asked also dr aptenerate is mainly is there are still some class 1 devices as a software as medical device we talked also about cyber security the fact that there is a lot of issues or things that you have to consider for the software and the last one about artificial intelligence related to the new regulation the european regulation that is coming where you will need also a notified body for that so the question is is you’re not right would be qualified for medical devices and artificial intelligence or is it qualified only for artificial intelligence so you have to you have them to select two notified bodies for for your product so um so yeah if you are developing a software as a medical device this episode is really made for you okay so it was a pleasure for me to introduce you to all those updates don’t hesitate to contact me if you need any support for your project if you need a consultant if you need some help so contact me at info easymedicaldevice.com if you need also a european authorizative uk representative responsible person uk responsible person if you need a swiss representative so don’t use that also to contact me i would be really it would be really my pleasure to to help you so uh then thank you again for uh looking at this video i don’t use that to go also on the show notes to look at all the links that i provided and i wish you a nice day [Music]
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Medical Device News - September 2021 Update

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