Preparing for Regulatory and Technological Change Across the Medical Device Landscape
Okay and good afternoon everyone um I think we will make a start um thank you for joining today's webinar um which is Preparing for Regulatory and Technological Change Across the Medical Device Landscape. Please note that this webinar will be recorded um if there are any questions please put them in the Q and A section which is on the top bar of your team's window and we can run through these later during the Q and A section of the webinar. If you have any feedback throughout, please use the link in the chat that will be provided um and we will get going. So I am Paula Sweeten, next slide please. Great, thank you. I'm Paula Sweeten um and I've been a Project Manager at Inno Scot Health for just over two years um before joining InnoScot Health I previously worked in clinical trials for the pharmaceutical industry and in academic research management.
Leading today's webinar we have Elaine Gemmell who's the Head of Regulatory Affairs at InnoScot Health and our guest speaker Dr Paul Campbell, a Senior Clinical Advisor at the MHRA. Elaine joined InnoScot Health in 2002 and helped to establish the organisation. She's a certified ISO 13485 and ISO 9001 lead auditor with experience of regulatory approval and CE marking for medical devices. She has a BSCB Eng in engineering and previously worked for Motorola Semiconductors for 20 years.
Following on from Elaine today we'll also have Dr Paul Campbell who is a highly respected clinician and expert in the field of healthcare information technology and regulations. After starting his career as a pharmacist, um Dr Campbell transitioned to medicine and became a consultant anaesthetist within the Clinical Informatics team um at sorry became a in 20 school 20 over 25 years of experience across multiple clinical and digital domains. He's held several clinical NHS and E- Health roles, including as a Clinical Director and Clinical Informatics um team in the NHS National Services Scotland. He's also a clinical advisor to the Scottish Government Digital Health and Career Department and is currently working as a Senior Clinical Advisor within the Software and AI Group at the MHRA. I'll now pass over to Elaine who will take us through the regulatory changes that are coming to the medical device landscape and then we will go over to Paul who will take us through artificial intelligence as a medical device. Can I have the first slide please Jane? So welcome to to everyone who's joined the webinar today um for a number of months I've been doing presentations and training sessions on how you regulate medical devices and looking at what's happening with respect to the Europe and the UK. Today I'm
going to do something just a bit different um as you're aware there have been lots of changes in the the regulatory landscape due to changes in regulations standards been updated additional requirements for notified number of bodies and just trying to keep abreast of the changing technology and what has happened in the light of the UK exiting the European Union. What I hope to do today is to summarise all of the changes and to provide some clarity and what we can expect to see when these um changes are fully implemented. Can you go to the previous slide please Jane. So before we start um what I will do is take a look at the regulatory landscape as it has been prior to the UK exiting the European Union. So while the UK was part of Europe um everyone worked to the Medical Device Directive and as part of the European Union the UK also worked to that directive.
Clearly this directive has been in place for a number of years and there were some deficiencies. Technology has moved on there's been new requirements, it hasn't really kept up with all the new technology. So there's a recognition that we needed to to update and to make the medical device regulations much more robust. So the Medical Device Directive, being a European directive had to be transposed into law in the United Kingdom, and this was done under a statutory instrument so the statutory instrument that amended the European directive set out three different pieces of legislation within the UK that we work to for device regulation. There was the directive for medical devices, one for active implantable devices and one for in vitro diagnostic devices.
The CE Mark is the Conformity Assessment Mark that you apply to products to put onto the market, to show that you've complied with all the requirements to make them safe and effective. The new requirements that I talked about being more robust, were set out in the Medical Device Regulation which was intended to be implemented throughout Europe. Being a regulation, this was directly applicable in all member states and there was no requirement to transpose it into into local laws. So the Medical Device Regulation was set out initially published in 2017, with a three-year transition window so it was expected to be fully implemented throughout Europe and the United Kingdom in 2020.
Had that happened according to plan um the UK exiting the European Union had set out within a withdrawal agreement that at December 2020 there would be a snapshot of particular laws that were implemented in Europe and these would automatically become UK law. So had the Medical Device Regulation been implemented in Europe in 2020, in May, at the end of that transition window in December 2020, the new regulation would have transposed into UK law and we would all be working to the the same legislation. So what actually happened? Next slide please Jane. Because of Covid, the implementation of the Medical Device Regulation in Europe was delayed by 12 months. That meant that it was no longer going to be implemented in May 2020 and was pushed out to May 2021. That meant that at the end of that transition window, the law that was in Europe at that particular time was the directive so that was what transposed into UK law. So now what has happened because of that delay, is that the UK and the European legislation are different. Europe currently regulates to the Medical Device Regulation and the UK currently
legislates to the Medical Device Directives. When the UK exited the European Union, they um put in forward a proposal for a new Conformity Assessment Mark so that is the UKCA Mark and that will be currently implemented for new devices regulated in the UK and will be applied to put product onto the UK Market. In Europe the CE Mark still is applied for products put onto the European market. We'll talk about some of the plans for accepting CE Mark and and the time scales associated with that um a bit later, but currently the CE Mark can still be, CE Marked devices can still be put onto the UK Market, however UKCA Marked devices cannot be put onto the European market. There is a slight further complication with um Northern Ireland, prior to Brexit trade between Northern Ireland and the Republic of Ireland was quite straightforward. Both territories were in the EU, both shared the same trade rules
but the European Union has very particular border checks that have to be done when goods arrive from non-EU countries, so when the UK exited the European Union had Northern Ireland been considered a non-EU country there would have been additional checks put in place and this would have implemented a hard border between the the countries in Ireland. To prevent this happening Northern Ireland continues to follow EU rules on medical devices and a CE Mark is required to place devices on the Northern Ireland market. Next slide please. So let's look at the framework for Medical Device Regulation. For both the directive and the regulation the process is the same. The first stage is to satisfy or to identify the essential requirements that are set out in the directive that are applicable to your device.
Just to simplify things for the purpose of this slide I'll I'll refer to to UK legislation so we're talking about the requirements of the Medical Device Directive. So once you've established what essential requirements apply to your product you'll then demonstrate how you're going to um provide evidence of conformance with these requirements. This is normally achieved by using harmonized standards, although as a manufacturer you are free to use other solutions to prove compliance with the requirements. Devices should be designed within a quality management system framework. ISO 13485 is the harmonised standard that sets out regulatory requirements for medical devices.
It was very recently updated to add annexes showing the relationship between the clauses of the standard and the requirements of the European Medical Device Regulations, and IVD Regulations. So it's also now harmonised to the Medical Device Regulation. Implementing standards will result in a body of evidence that will demonstrate compliance with the essential requirements. All of this evidence is recorded in a technical file which is pulled together within the technical documentation, and the manufacturer signs a Declaration of Conformity to state the requirements of the directives have been met and this will be also included in the technical file. Both the technical file and the implementation of the quality management system
will be examined by an approved body and the UKCA Mark can then be applied to the product and it can be put onto the UK Market. There are a few exceptions to this conformity assessment route. For very low risk devices that are in Class 1 that don't have a measuring function and are not sterile, an approved body is not required to examine the QMS or the technical documentation. The process is that the manufacturer signs a Declaration of Conformity, he effectively self-confirms that you comply with the requirements and the CE Mark is applied and it's put onto the market. Next slide please. So we're now going to talk about the implementation of future regulations.
Clearly the directive was already established as being not necessarily fit for purpose in today's new technological age and the UK had always intended to go to a much more robust um regulation framework. So in 2021 the Medicines and Medical Devices Act was put in place to allow the government the powers to amend Medical Device Regulations. In September 2021 the MHRA launched a public consultation to gather views on future UK Medical Device Regulations. The consultation set out particular scenarios with questions and these questions very closely aligned with what is currently in place in the European Medical Device Regulation. Manufacturers, Trade Bodies Health Boards, Universities and any other parties with an interest were invited to comment on the proposals. In June 2022 the response to the consultation was published. If you're interested or if you
want to see what the the thinking was, this is available on the MHRA website for you to download and look at. The process was that the feedback received from the consultation was documented and then the government provided some clarification and then set out their response, and in this response there's quite a clear indication of what the future UK regulations will look like. As a result of this response to the the consultation there will be three statutory instruments laid in Parliament in 2023 to implement future legislation. In April 2023 there was a statutory instrument put in place um to extend the time frame for acceptance of CE Marked devices into the UK, um and I'll give you some time skills associated with that just shortly. In the summer of 2023 we expect a statutory instrument which will implement much more robust post-market surveillance requirements for manufacturers. This will be done
ahead of the full implementation of future legislation. So this is put on post-market surveillance right up front and implementing at a much earlier stage than the new regulations. In Winter 2023 towards the end of the year we expect a further statutory instrument on the Future Medical Device Regulations and this will be the first indication in full of what the regulations would look like. The expectation is that the core aspects of the future regime for medical devices will apply from the 1st of July 2025. Next slide please. So just very briefly what can we expect to see in the new regulations. As stated the questions that were asked very closely aligned to the EU MDR so it's quite safe to assume that it won't deviate too far from what is implemented in Europe.
Although we won't cover all of them today, some of the proposals for the new legislation will include um changes to scope, what comes into scope for medical device regulations and this will include devices without medical purpose. Some examples of this would be equipment for liposuction, um anything with lasers, perhaps used for hair removal or tattoo removal, dermal fillers, non-prescription lenses, or cosmetic implants. There'll be changes to the classification of some medical devices and this can be quite significant for some manufacturers in particular the implementation of a neural for software may result in a lot of Class 1 devices which were previously self-certified been reclassified to Class 2a and above which will mean that an engagement of an approved body or a notified body will be required. Other changes to classifications will be concerned with IVF in and assisting reproduction technologies, surgical mesh, total and partial joint replacements and other technologies which potentially will go into the highest risk classification of Class 3.
There will be new essential requirements introduced to the directive to make provisions for emerging technologies such as nanomaterials and there'll be new requirements on manufacturers to have financial covenant in place for compensation when adverse instance occur. There'll be other changes that will provide clarity on the definition of Health Institutions, and the exemption will no longer apply but there will be a requirement for registration of medical devices that have been manufactured or modified in-house by Health Institutions. There are particular requirements for a qualified person to be available to to manufacturers um on a permanent basis on for medical devices to have a unique identifiers. There are lots more changes that will come into force and if you're interested to to have advanced notification of what these are I would encourage you to go and look at the response to the the consultation. Next slide please. So now we're going to look at the the transitions. Next slide.
So the first statutory instrument that I talked about um that was laid is expected to be passed by the 30th of June 2023. What this is going to do is to extend the period when CE Marked devices can be placed onto the market so there's there's certain different types of scenarios that you you need to be aware of. If medical devices or active implantable medical devices have been regulated in Europe to the old directives assuming they have a current certificate they will be accepted onto the UK Market with just a CE Mark until June 2028. If devices have been CE Marked through the MDR or the IVDR or their custom-made devices that have been regulated to the Medical Device Directives, they will be accepted with a CE Mark on the UK Market until June 2030. Next slide please.
So we talked about um post-market surveillance being implemented ahead of the future um legislation the second statutory instrument will put in place these requirements for post-market surveillance. Under the Medical Device Directive it's not particularly well defined and all it says is that manufacturers should maintain a systematic procedure to review experience gained from devices in the post-production phase that doesn't give a very clear indication of what should be included and also it leaves it very open so manufacturers may do very different things. The legislation that will be laid in the statutory instruments will aim to to strengthen the requirements for post-market surveillance um and among other things it will include details of what should be included in a post-market surveillance plan and post-market surveillance system. So it will be much more prescriptive it will look at pro-active patient safety monitoring, increased reporting of adverse incidents, tighter timelines for reporting advanced events and an indication of the frequency of how how frequently these reports should be updated. It's expected to apply from mid-2024 so that will be ahead of the the new regulations that are put in place for the UK. Next slide please. So I've touched very briefly on the regulation of medical devices in in Northern Ireland and as a result in Northern Ireland the CE Mark will still apply. Now with the exit of the
UK from the European Union the situation with notified bodies has changed and in the UK we have approved bodies that are designated to do the Conformity Assessment. Currently these UK approved bodies are only able to um approve devices to the Medical Device Directive and apply the UKCA Mark. There are provisions whereby UK notified boarders can apply for designation to conduct Conformity Assessment for Northern Ireland to the Medical Device Regulation. If that was to happen there would be a completely new mark that would indicate that and it's the UKNI Mark. Currently there are no notified bodies designated to do that but the provisions are there should they should they be appointed in the future. So to date only the CE Mark will apply in Northern
Ireland. Next slide please. So you may have heard of the The Windsor Agreement that's been recently negotiated it's a set of solutions to safeguard the supplies of medicine to to Northern Ireland and the UK and European Union have reached agreement to safeguard the supplies into Northern Ireland unfortunately in this the medical devices do not receive specific attention so whatever was agreed under this agreement does not apply to to medical devices. So the situation where you will have to have a European notified body and a CE Mark for Northern Ireland still still in place, so nothing has changed with that. There's a very clear indication however that should the Windsor Frame Agreement go well there are provisions that additional um legislation can be brought into scope and the hope is that medical devices will be added to the future scope. Next slide please.
I talked about approved bodies and these are bodies that are designated to do Conformity Assessment within the United Kingdom. As of today there are four UK approved bodies but they're designated to do slightly different things. So currently the only approved body that can do all um devices, medical devices active implantables, and in vitro diagnostics is BSI. SJS are designated for medical devices and in vitro diagnostic devices. Decra who's the most recent approved body to come aboard can do medical devices and UL International can do IVDs.
If you're going to select an approved body to to regulate devices in in the UK it's important that you actually go and look at their designation because while we say that Decra have a designation to do medical devices there are some different categories within medical devices that they may or may not be able to do um when I last looked which could be out of date I think it was the end of Q1 I last looked at it, while Decra could do medical devices they were not designated to do active medical devices so they couldn't do software and they couldn't do anything that was powered so it's important that you actually look at what they're designated for. Six organizations have applied, in addition to this, six organizations have applied to become UK approved bodies and there are more that have expressed an interest so the hope is that as more and more um approved bodies are designated um the strain that notified bodies are under, or approved bodies are under um will be eased. Next slide please. So in addition to what's happening in the United Kingdom with respect to notified bodies and approved bodies being able to certify products um there is a recognition in Europe that there is a a very real um constraint on notified bodies being able to take devices that were previously approved to MDD and to update them with respect to the MDR. So the transitional periods for compliance with the Medical Device Regulation has been extended the reason for this is to avoid medical device shortages and to ensure continuity of supply without compromising patient safety or performance of the device. So manufacturers have been given more time um to comply with the Conformity Assessment of devices being regulated to Medical Device Regulation as long as they're covered by a certificate issued in um accordance with the Medical Device Directive and that that they have engaged with a notified body and have a contract a written contract in place with them for future Conformity Assessment. Under these conditions, if they satisfy both of these conditions Class 1 devices can continue to have the CE Mark and be placed on the European market in accordance with the Medical Device Directive until 2028. Similarly with Class 2a devices,
Class 2b and Class 3 devices have to be in compliance by December 2027. So that is all I was going to say with respect to the the future legislation clearly there's a a lot of things happening and in line with changes to the regulation, one of the very high profile issues that's been talked about is the regulation of software in general but in particular how to regulate artificial intelligence. So I'm now going to pass over to Paul who's going to talk specifically about artificial intelligence as a medical device. So over to you Paul. Ok I'm about to hopefully share my screen Okay thanks so much Elaine for an excellent presentation, a great coverage of of the ins and outs of the the regs there but as you said we're going to touch on artificial intelligence as a medical device now uh and yeah I'm going to tell you about about the the ins and outs of that, the problems, the challenges of that and hopefully Wrong button sorry folks. So Elaine you mentioned to start there this actually software as a medical device you know and I'm sort of going to start at software as a medical device before getting into AI as a medical device. if from the legislation point of view it's all classed as software to
be honest and it's probably just worth reflecting on the breadth of where software now touches the healthcare landscape it's pretty enormous it's sort of involved in everything now you know triaging diagnosis, we've got digital medicines, companion diagnostics, clinical calculators, IVD software so so software is intricately involved in and all this now in doing great clinical things and also potentially if it's not done well creating clinical problems and and error. So software is really quite a large part of the healthcare estate now and and hence the the review globally about the regulations round about software and I'm going to go on to the next bit and again that's just this indication that artificial intelligence is currently part of software, a sort of subset of software. I would note though I think we all know, you just have to look at the newspapers and you'll see that artificial intelligences is becoming ever bigger depending on how you define artificial intelligence as well that the size of that that circle there can be bigger or smaller because even the definition of artificial intelligence is complicated but worth noting that it is all part of software and we can consider it that way just to start with and so in terms of starting uh the name MHRA that the Software Hub is a new page that we've published and we've got a bunch of sort of guidance documents on it this is one of the most recent ones this is a sort of start point and and we try really hard to let people focus on what's the intended purpose of your software, because often it's very nebulous and it's very hard and if you've got a nebulous purpose it's quite difficult to prove that it works. So we've published this guidance about how to craft and intend the purpose, Elaine mentioned the technical file before, this is a core part of your technical file for your product so some guidance in there. I suppose in summary briefly it focuses on what does your device do, who does it do it for, who are the people that use it, and and also the user environment or the use environment. So these these four points at the end there are worth considering uh for your intended purpose but there's more detailed guidance on on the website there. In terms of all software and particularly AI but all software
we have to go into the next thing which is that to try and classify the device Elaine mentioned Class 1 devices or Class 2a devices then there's 2b and 3 so as the classification goes up that that's in in respect to the risk going up and there are some notable features about risk when it comes to software you know at the click of a button you can turn on software to millions of people that they now have access to the click of a button you could run an analysis on thousands, tens of thousands of people's you know records and clinical records that could lead to uh output of information that determines treatment plans for them so the size and the scale of this is is really quite of note and I think increasingly we noticed that there have been a few, if you look back through the press there have been a few notable fairly large-scale IT problems in healthcare but also outwith healthcare so when it happens it can it can be big and most of this non-linearity of of a impact from a change you know again a simple minor change a bug in a line of codes can can have a very very large effect literally because of a minor change and a bit of code so so that's quite of note. Two points at the end are worth, human computer interactions I think that there's a growing evidence base that we need to be better at that in fact that that's taken account of in the in the consultation and in our sort of software roadmap that we're developing to provide guidance. We need to understand not just how the tech work but how the tech works with the humans in the environment they use it in, the clinicians and patients that are using it so that's really important and then finally the, Elaine mentioned about post-market surveillance within that everyone just uses the phrase adverse events roughly speaking but that it's it's notable that post-market surveillance includes assessing for indirect harm, indirect harm you know you use information that's fairly pivotable in in a patient's treatment or care and harm occurs then that would be classed as indirect harm. So software
is very much in the space of indirect harm but but that is covered by the legislation and and by what we're trying to provide guidance around and we recently released a software specific device uh specific vigilance guidance, again that was just published last week again on on the Software Hub page, all the references will be in this slide deck for anyone who wants it. Of course you know all these things bring you risk but they also bring unique benefits so it's just you know why we're here it's why so many people are using it because there is actually you know fairly significant potential what can be done to help the whole collective of patients you know clinicians, health services, they interact between them all so lots of potential benefits there uh but yeah we have to consider all those those risks that go with it. So I've covered sort of software in general and this is a talk about artificial intelligence as a medical device but hopefully that's positioned it as a subset within it but but how is it different you know in essence you have an input you develop a product, that product has inputs of information it goes into the computer, it does a thing and it then it does that to a certain level of performance or desired or declared outputs you have those outputs and the outputs go to the patient how's that any different from anything else. Well these are possibly some of the bits that that are specifically notably different for artificial intelligence and by that is that this is because you are fundamentally sort of teaching or training or running a model where you're putting in large data sets to train and create models in the first place even if that if that's a fixed model you're still running this on large data sets, so it brings a huge challenge around the bias we can go into this you know the bias of the literature, of the data that's gone into it, the population you've chosen, the features of that population, is that population the same as the population you're using it in, does it disadvantage certain character characteristics or certain groups, so bias is a real challenge. The next one is interpretability uh so we have sort of explainability and transparency they're subtly different but it's two sort of different things that the way I sort of think about it you know as a clinician is the transparency element, could I look into the software as such and could I understand what it's doing so when it's giving me an answer I can I can understand why it gave me that answer, what were the features that mattered that made a difference and then the explainability if the patient for example were to ask so you're telling me the the computer says I have to start this treatment of this medicine now doctor and why, why is the computer saying that if you know can I explain that to the patient if I can't explain why the the artificial intelligence has concluded this then that's a problem and creates a problem of trust.
Another really unique feature for artificial intelligence is sort of adaptive adaptivity or changes in the program, there's a number of features such as sort of drift in the data and the data analysis that can occur and even just updating the software, updating your data model how do we do that, these are fairly challenging things to do you're talking about changing live medical devices so changing devices takes a fair amount of work and and what are the plans that we can put in place for doing that and and what risks are associated with making those changes. So these are really they're not the only ones but they're probably some of the biggest and most important specific issues about why artificial intelligence is sort of over and above software and it's a bit difficult and as Elaine mentioned earlier you know we're currently on operating under the MDD Legislation in which at the time it was written you know there was no mention of artificial intelligence so so we're trying to make all this work and provide guidance along the way. Hope that helps with that, uh I I mentioned I've said a few things before I just wants just to see we've got this change program uh roadmap this is this is on the website and it covers a series of work practices on qualification, classification, pre-market, post-market and and cyber as well becomes important and there's a remaining three which are specifically on artificial intelligence so you'll see we've got AI rigor that's all about the the evidence that the proof that your product works and it does work in an unbiased way and adaptability and adaptivity so we and we are already delivering on this and intend to continue delivering so if any outputs we can as and when we can alongside legislation uh by way of guidance so that we can provide as much information to sort of developers, entities, health services, patients, markets, you know so so that people can understand where we're going with us and hopefully so far we've actually had some pretty good positive feedback on on the guidance we've put out of late. One of those elements of guidance uh that we did is one of the work practices related to I think a good machine learning practice so if you are in the in the landscape of developing artificial intelligence or machine learning programs this is a piece of work that the MHRA did with the US FDA and Health Canada and it produces a start point of here are some principles to focus on if you're developing machine learning practices and some really really good ones in there you'll see in there that you know the bottom the performance of the human AI team uh they have to provide users with clear and essential information, the training data sets should be different from an independent from the test sets they used in the training and testing is different otherwise you're in a way of potentially marking the same homework so so this is this is available on the web and and is a very useful set of principles if you're setting about you know developing a product in this space. Then again I've mentioned that we have produced this and what we're calling our Hub page we are trying to specifically pull because there's so much knowledge, information, documentation in this space we're trying for the software side of things to pull all together into our Hub page which we we launched there in April, I was going to say about six weeks ago so hopefully that's useful and people can find much there and we hope to populate that further as we go along.
Elaine stole my thunder the the future consultation is a great place to go to to get to get you know to get the the results of what was concluded from that consultation you can see the government response you can also really interestingly see what what the the sort of marking from the respective respondents be the industry or healthcare services so so that's a bit about software and and AI and the specific challenges, hopefully that that's been useful. If if I may I'll just touch very briefly on a couple of other things to consider. This landscape of medicine and healthcare that we're living in is unfortunately is becoming increasingly complicated and and that's you know dangerous enough concern and it's because we're doing increasingly you know more advanced things and we're improving health but it's of note, Professor Cyril Chantler you know and any physician who's involved in in many reviews endless of changes to smoking so legislation so uh anyone in that position, I just thought it was a useful sort of quote and and worth taking note of something a bit more detailed than that in this complexity, on the right here you you see this is an analysis of oncology treatment patients, cancer nurses, research staff, from 2012 to 2015 so even in that short space of time and that's now eight years ago, this was in Australia, you can see the growing depth of complexity within elements of sort of complex clinical care and so we have to recognize we're working on a really complex system particularly for AI, particularly for software you know you may think you change one thing over here and and that will lead to a predictable outcome, unfortunately that's not always the case in a complex system and it's not necessarily always a case in artificial intelligence as well so we have to be very aware of that and we also have to be aware that when we roll out any of these products they go into a system that's not, it's complex but it's not static, the system and the people round about it adapt and change as well and so it's within that environment that you really have to make sure your products are shown to work. A couple of other things you know there's now some
some evidence, this is a paper from last month, I'll not spend too much time on it the long and short of this one is that this was a review of machine learning devices in the States and it's shown that you know there are adverse events that are harm that occurs it's often with uh there's a large scale problem with the data inputs to the machine learning that there's a lot of harm there, but then also use problems, there's a there's a real challenge for a relatively small number of issues related to use problems but actually they're more likely to be related to harm so I just thought it was a useful paper again all the references are there I thought that'd be one more taking note of for anyone interested. Another point of consideration is that workflow automation so if you look at this this diagram here we've got the pale blue in the middle of treatment and care delivery you know that's the sort of the clinical end of healthcare but healthcare is all of these different parts to running a healthcare system and actually we're sort of taking some of the most complex technology and we're deploying it in probably the most complicated part of that healthcare system, straight into clinical care so this is a really useful paper that indicated that that's not normally what most other industries have done is if they become an increasingly digitized or particularly using artificial intelligence they tend to approach you know less complex areas to start with to learn and throughout that technology so administrative operational you know surveillance so so it just makes the case that there's lots of other advantages that can be found across the whole of the healthcare estate that could use AI and and it would all benefit the whole of the health care estate but of notes we tend to have jumped in straight at the most complicated bit in healthcare generally speaking so that's an interesting paper and the last thing is the evidence, so we have the intended purpose what does your product do but how can you prove your product does a thing, what evidence have you got for that and the evidence questions really quite difficult because it depends who you're asking, are you proving it to a regulator, are you proving it just to get an idea published but you're not actually proving the product, are you proving specifically that it's safe, you have to think about the whole life cycle of the product uh and and of course with all new technologies we notice you introduce a thing, and you will end up with unintended consequences, things that were not foreseen, so you have to be aware of that and capture some evidence around that. Again humans, and getting on to the end here we have to get is it economically viable, to have a valuable product you have to do the sums on this and work out if putting all this in place, does it make sense as economically, but is it good enough will people use it, so I think that evidence thing I'll sort of summarise with my own little algorithm, I suppose it's somewhat artificial, these are in my head three questions I get asked quite a lot you know does it work, is it safe, is it useful, and I think anyone embarking on or involved in products should you know constantly reiterate those those questions - does it work, is it safe, is it useful, and can you prove that uh and yeah if you can do that then you will create valuable products so there is a lot of value can be found there but I'm going to pause now I'll come off screen, I believe there's a question session and I hope that's roughly to time folks. Thank you. Okay thank you very much um Paul for a really interesting um summary there that was very clear, and we have had a few questions come through in the Q and A that I will put over to both you and Elaine um but we have only got five minutes or so left I think, we'll do five minutes of Q and A and then just wrap up the presentation. If anyone does have any other questions please feel free to send them through to us, and the whole webinar will be made available online um after this session. So the first question that came in was do Class 1 devices on the UK Market by virtue of their CE Mark require to apply to the UKCA Mark prior to the 1st of July 2025? um I'll pick up that one um from Ed hi it's nice to see you here um so CE Marked devices were originally intended to be accepted onto the UK Market until June 2023, that's now been extended as you indicate to to July 2025. The extensions that we talked about
um really follow on from what's happening in Europe with the extension to the requirement to transition to MDR so the only Class 1 devices that this further extension would apply to would be ones that would require the engagement of a notified body, so with the new regulation that would be any devices that had been up-classified, that originally had been Class 1, but now you have a higher classification and require a notified body to assess them or reusable surgical instruments which is another Class 1 um function that now requires notified body so to answer your question for Class 1 devices that don't require any notified body engagement they would have to be your UKCA Marked to the UK regulations um prior to July 2025. Thank you, thank you very much Elaine um we've got one more question in the Q and A section right now which we can do but if anyone has any others please feel free to pop them in. The next question is will there be a more streamlined way to determine if it is a medical device and what class it comes under? So again I can I can pick that up and by more streamlined I'm not sure if you mean what's currently available, or the way the new regulations are set out, there are guidance documents that are published and currently there's a lot of guidance around the Medical Device Directive, the new guidance for the Medical Device Regulation and for future UK regulations are very slowly coming online so to answer your question um there will be um guidelines on on classification that will set out how you determine what classification your device is and the way to determine if it's a medical device is to go to the the definition and they'll probably be a new clarified definition within the new regulations and if you can answer yes to any of the sets of criteria that are set out in the definition then it will be a medical device. There will also be guidelines on borderline devices which again will will come on stream as and when they're available and there will also be um the ability to go and ask for advice from MHRA if you're really not sure about borderline medical devices.
Okay that's great thank you Elaine, and we don't have any other questions in the Q and A right now but as I mentioned earlier please feel free to get in touch um if you have any questions down the line. In the interest of time I think we'll just carry on just now and so next slide please. So thank you for joining today's webinar, we have recently started um a webinar series here at InnoScot Health and we've got two more um coming up in the next few months, the first one is on the 21st of June 2023 um and it's on protecting your Intellectual Property, we'll then take a break for the month of July and uh previous slide please, then we've got one more in the 30th of August um which is the Clinical Entrepreneur's Webinar. So they will all be available um to register online um at the address that's given there. Next slide please. So just to sort of wrap up um on some of our latest news that we've had here in InnoScot Health, um we actually work with a range of partners and provide regulatory support and consultancy to them and we're pleased to say that in April of this year we congratulated our partner MR CoilTech on being awarded um ISO 13485 accreditation which is the official certification they gained after being recognised by the British Standards Institution or BSI, for operating a compliant quality management system and meeting strict guidelines. MR CoilTech was set up in 2015 um to commercialise radio frequency coil devices for a new generation of ultra high field MRI scanners, they're a Glasgow-based company that work in the Imaging Centre for Excellence the Queen Elizabeth University Hospital, where there is a CE Marked Seven Tesla Scanner that the company use to develop coils specially tailored towards the needs of clinicians and researchers around the world.
We're very privileged to have assisted them with gaining their ISO 13485 accreditation and we are continuing to support them in the development and commercialisation of their coils. Next slide please. So if you have any um queries you can visit our website here where you can come and visit us we have a lot of information online but you'll also find the details of everyone who works at InnoScot Health, ways of contacting us and booking a consultation with one of our Innovation team if you'd like to do that. Next slide please. So thank you very much for attending um here at all of our details if you wanted to contact us via email, if you have any questions after today's webinar. Equally or
on Twitter and on LinkedIn, and thank you very much for attending. And thank you especially to Paul and Elaine for all of their insights and the information they've shared today, thank you.
2023-05-31 11:40
