So yes, thanks to John for the opportunity to speak to you all today, obviously it’s fantastic to see so many faces and frankly after 15 months of home working it’s fantastic to see faces full stop, so thank you for that. As John said, I’m a medical device specialist at the MHRA and have been there for the last four years or so. My responsibility is mostly in the post market phase, so that’s reviewing any adverse incident reports that come in, but I also work some parts with assessing clinical investigations and other topics like that. So what I’m here to talk to you about today is really just a refresher on the role of the MHRA in medical device regulation. A quick run through of some of those changes that have been put in place in the last couple of years or so and what’s coming up this year.

A reminder about the importance of adverse incident reporting, both the requirements that manufacturers have in terms of vigilance and also what healthcare professionals and as members of the public you can do to help support that and a quick discussion on what communications you might expect to see from the MHRA in terms of our own publications and also field corrective actions from manufacturers. I’ll always add a quick health warning, these slides are based on my interpretation of the regulations as they are at the moment and my best current understanding. The MHRA would always advise you to seek professional advice if you need it. So yes, first of all a quick talk about the MHRA, we’re the UK National Regulator, but actually within the MHRA there’s several quite disparate groups sort of lumped together organisationally.

So as well as MHRA the regulator that you might be familiar with we also have CPRD, that’s the clinical practice research data link who are responsible for harvesting data from GPs to leverage that in developing new treatments and new studies. One that’s got quite a bit more publicity in the last year or so is NIBSC, the National Institute for Biological Standards and Control, they’re the ones responsible for assessing vaccine batches and other biological standards to support that and medicines work. And then lastly within the regulator we have the Medicines Regulator, we have the Medical Device Regulator where I work and also the Regulator for Blood. To focus in then on the medical devices, obviously that’s where my expertise is and where I imagine yours is too. The MHRA is the UK National Competent Authority, below that we’re responsible for approved bodies, that’s a rebranding of notified bodies.

Those are UK-based assessment agencies that can carry out conformity assessments for those higher risk devices that need that for their declaration of conformity to the requirements. We also register UK responsible persons, again a rebranding of the authorised representatives under the previous European system. And then as well as that we also work with device manufacturers directly, we help and support patients and healthcare professionals use the devices that they have effectively and that’s through a range of means, so although the names have changed, actually the structure of that has remained largely the same despite that. I’ll talk a little bit about device regulation in Great Britain, Great Britain is a deliberate choice in that title because there are now quite significant differences between how things work in Northern Ireland and how things work in the rest of the UK.

Unfortunately the MDR and OVDR that were due to come in are now not automatically retained as part of the EU withdrawal agreement. The MDR was due to come in last May, that was postponed obviously because of COVID and that pushed it outside of the transition period meaning that in the UK the regulatory landscape is still based around the Medical Device Directive, the Active Implantables Directive and the In Vitro Diagnostics Directive. And it’s a similar story for the In Vitro Diagnostic Regulations, that had a longer sort of lead in time, that was due to come in next year and again falling outside of the transitional period, that means that those regulations are not going to be put in place in Great Britain in the immediate future. And as I said, the legislation that currently applies is still based around those three directives, so in reality a lot of the things haven’t changed for manufacturers, they still have to comply with the same requirements that have been in place for some time. Those three directives fall into the UK Medical Devices Regulations and as of this year as well we have the UK Medicines and Medical Devices Bill as well. OK.

And obviously that means some changes are falling out of the European system with how that will work. So previously everyone was used to the CE marks that were applied through the regulations, those remain valid for now but there is a transitional period again to move to what are called UK CA marks, so that’s been a possibility for manufacturers to start using from the beginning of this year and there’s a gradual transition period until July 2023. As I mentioned the requirements for those remain based around the Medical Device Directive, the Implantables Directive and In Vitro Diagnostic Directive. The changes will be that you will require a UK approved body, previously a notified body, to apply that UK CA mark for those higher risk devices in classes 2A and above. So you should begin to see these kind of marks in the near future.

Another change for manufacturers is that we now require the registration of all kinds of devices, again on a rolling timetable over the next year. Previously manufacturers were required to register Class 1 devices with the MHRA, that’s being extended to all device groups. So you can see the timetable there, we have from the beginning of May this year, the kinds of devices that required were those very high risk ones in Class 3 and active implantables. From September that will be applied to Classes 2A and 2B and then by the end of the year all Class 1 devices and it is worth pointing out that if you’re a manufacturer of custom devices, that needs to be registered in line with the others. It’s worth pointing out as well that the Health Institution Exemption remains as it was prior to that transition. The next change around UK responsible persons, again this is really a transposition of what was required for EU authorised representatives, but now those are required for non-UK manufacturers on the GB market.

They have to be established within the UK, whether that’s actual, you know, office space or some other form of sort of legal representation or registration. Again that’s a 2021 requirement that should already really be in place and those responsible people will be the ones that need to register medical devices with the MHRA throughout this year, unless of course the manufacturer is already based in the UK. A quick list of some of the other responsibilities that these UK responsible people have, these again are generally in line with those previous responsibilities of authorised representatives. So it’s in terms of keeping hold of documentation and making that available to people that need to see it, providing samples of device, cooperating with informing of correctives actions and mitigating those risks. And being that conduit between regulatory agencies and manufacturers where those need to be in place.

They also have some additional responsibilities in terms of making sure that the manufacturers are meeting those obligations and has an obligation to terminate that legal relationship if they find that the manufacturer is acting consistently against that and to inform the MHRA of course of that sort of thing. A quick note on notified bodies, those became UK approved bodies at the beginning of this year, again at the end of that Brexit transition period. Going forward they will not be able to do conformity assessments for the EU market, they will be the only ones able to do so to supply the UK CA mark. So going forward, EU based manufacturers will need to seek out these approved bodies in order to get the UK CA mark once that grace period for the CE mark runs out. And this slide is really just to give an overview of those timelines in the next few years.

So UK responsible people should already be in place, registration should well be underway and manufacturers really do need to start being prepared for the end of recognition of EU CE marks for medical devices and those UK CA marks being necessary. And I’ve got just one slide here on Northern Ireland because it’s really a talk to itself, it’s a very complicated situation. The fundamentals is that as part of that EU withdrawal agreement Northern Ireland is implementing the EU Medical Device Regulations and keeping that border free to do so. There’s plenty of information on the MHRA website if you’re going to be affected by devices being supplied across the Northern Ireland, Republic of Ireland border or between Northern Ireland and the rest of the UK and it is worth checking out just to see what is going to be required as part of that. I’m going to move on now to those reporting obligations, so starting first with manufacturers and then what we would like to see from healthcare professionals to help support our work.

Again those vigilance obligations and expectations remain pretty much the same before and after Brexit, so manufacturers still have that obligation to report to the MHRA particular incidents that meet certain reporting criteria. They have the responsibility to do that investigation and to take appropriate corrective action when necessary. The MHRA’s role in that is to monitor those investigations, to take further action to support those investigations where possible and to keep track of those corrective actions as they take place on the market. The user’s responsibility is really to help support that, is to report incidents when they become aware of them, to manufacturers and to the MHRA to make sure that the rest of the system is functioning. These vigilance reporting criteria are lifted from the previous MED DEV Guidance, these expectations remain the same under the new UK system.

The criteria for making something formally reportable from a manufacturer to the MHRA basically has to meet all of these three criteria, there has to be an actual event that has occurred, that can include examination of the device beforehand. The manufacturer’s device is suspected to be a contributory cause of that incident that’s occurred and that event might have led or did lead to the death of the patient, user or other person or serious deterioration in the state of health of anybody involved with that device and once those conditions are met, that needs to be reported to the MHRA. In practicality the practical considerations around that is that we expect manufacturers to report things in borderline cases, these can then be assessed in more detail once more details of the investigation are available, but that predisposition is always to report something and amend it later if necessary. We always expect those reports to be made without delay, but there are these guidelines for times within that guidance. We expect it within two days for a serious public health threat, so that might be for where there’s a risk of transmittable disease for instance.

And we expect it within ten days of a death or unanticipated serious deterioration in health and within 30 days for all other cases, but again it should be without delay, they shouldn’t be sitting on reports waiting for these deadlines to come up, the predisposition is always to report as soon as possible. Manufacturers are now obliged to use the MHRA MORE portal online to submit these reports or to use the standardised XML reporting template. And within that we’ve now introduced standardised terminology for adverse incident descriptions, clinical effects and the investigation methods that have been used. That’s to make it more straightforward to group trends together too, to understand those kinds of incidents and to compare between different devices.

But this can also really be supported by healthcare professionals and indeed members of the public. What we’re interested in hearing from you is really any event that has the potential to cause unexpected or unwanted effects involving the safety of devices and the safety of patients and this can be really quite a wide range of anything. We want to hear about it when someone is injured or almost injured by a medical device. We want to hear about it when instructions are unclear or labelling is insufficient. We want to know about it when devices don’t work properly, when the patient’s treatment is interrupted or delayed or changed because of a faulty device, we want to hear about these things. We need to know when you think you’ve been given or sold a fake or counterfeit device so we can take action there. Even if devices are just of poor quality and don’t work as expected or don’t do the job that they need to do, we really need to hear about this so that we can inform the manufacturers and monitor those investigations to make sure that those corrective actions take place when they need to.

And really the bottom line is that if you have any concerns about the safety of a medical device please do tell the MHRA. One of the most frustrating things is to go to a meeting of engineers or technicians or device users of any kind and to ask if they’ve heard of any device problems that they want to discuss and they all, someone puts up their hand and says oh yeah we had an incident, this device broke, but it was a one off and we didn’t report it. Because you can guarantee that around the table everyone else will suddenly put their hands up and say oh yes we had a one off like that as well. And suddenly those one-offs become a trend and become reportable and become something that’s worth investigating. A bit here about why to report and hopefully you’re familiar with the yellow card website. There’s really no such thing as too much information in a report, we really appreciate those reports because they give a different perspective from a manufacturer’s report.

If you remember I mentioned those formal reportability criteria, there are many cases where a manufacturer will err on the side of something not being reportable, well naturally we really want to hear about it. And those inconveniences and device problems can be the beginnings of a signal of a bigger problem and that helps us raise that with the manufacturer and gives us that intelligence to investigate and take things further. It really gives us that opportunity to get that bigger picture of what’s going on in the devices world across the wider market and beyond what is just formally told to us by the manufacturers when they’re obliged to do so. And really the benefit is that it can lead to device improvements for everyone, because if problems are detected then obviously we can do something about fixing them.

And of course anyone is welcome to report through that yellow card scheme, whether that’s healthcare professionals, whether that’s patients, whether that’s members of the public, whether they want to report medicines or medical devices, even, you know, defective or counterfeit products, e-cigarette issues and all sorts, there’s this portal to do that. And of course if you’re in one of the devolved administrations, if you’re in Scotland, Wales or Northern Ireland, then you’ll have your own local reporting systems that do feed into the overall, the national MHRA scheme. A quick summary on what happens to a report when we send it, that user reports to the MHRA and it gets added to our database, we then always pass that to the manufacturer whenever possible, so it is really important that you identify that device as thoroughly as possible.

The manufacturer investigates and may get in touch with the original reporter to better understand what was going on and then if necessary reports back to us using those formal reporting templates. We review any corrective action that takes place, the manufacturer may issue field safety corrective actions or other communications to device users and we may take further action and issue further advice as necessary. So that’s kind of the flow of how that works. What those communications might look like, the biggest innovation really are these national patient safety alerts, the MHRA has been accredited to do these for the last year and a half or so and this format is really reserved for those most serious issues that require action from senior management and at the highest level. They’re issued via the central alerting system, so it should be possible for everyone to become aware of these.

These reports are of a standard format so whether they’re issued from other organisations, I’ve given the example there of NHS England, NHS Improvement, it should have the same format, you should see the same request for actions in the same place and it should have, make it easier to understand what’s being asked of you on the frontline. It will certainly include specific recommendations for what you need to do to address the particular risk. We always produce these in conjunction with stakeholders, so this should be an understandable message, it should be something that’s useful and relevant to device users and it is worth pointing out that meeting the requirements within these patient safety alerts is something that is assessed by the CQC, so in case you did need another good reason to do it.

Hopefully you’re all also aware of Medical Device Safety Officers, the MHRA helps run that forum and that organisation of device specialists and device safety specialists. We host the monthly WebEx meeting to discuss any sort of emerging issues or new guidance that’s come out and we also may use MDSOs to send targeted communications. So if a field safety corrective action hasn’t been as effective as we would like and hospitals are effected, then that’s another route to reach those end users just to make sure that they’re all aware of what’s going on. Field safety notices continue, these are of course a manufacturer’s document and we support the manufacturer where possible to make sure that that reaches everyone that’s affected, but this does fundamentally remain the responsibility of the manufacturer to make sure that this is something that is useful to customers and they are responsible for making sure that it reaches them.

Again these are done in response to something that poses a serious risk of harm, so it really is important that people are aware of these when they happen and respond to them. If you do get an FSN we really do appreciate you making sure that you let the manufacturer know that you’ve received this and taken the action that are listed. We do keep track of all FSNs that we receive and that reconciliation rate of hospitals confirming that they’re aware of the issues and they’ve taken action is really important for us to know that we don’t need to take any further action, so prioritising those and listing those is really important. As I said the MHRA reviews all those FSNs, we upload them onto our website if the UK’s affected and we really do assess the manufacturer’s success in reaching customers, so that is really important.

So a quick summary of what I’ve talked about today, so the MHRA remains the Regulator for medical devices in the UK and although there are changes for medical device manufacturers in terms of registration, the UK CA marks, responsible people, approved bodies, actually for healthcare professionals and members of the public our advice really remains consistent. To be aware of what manufacturers are telling you about the safety of their medical devices, reporting anything you think is unsafe or suboptimal and those requirements and requests for action really remain the same under the new environment; and again that plea to really report any adverse incidents to the MHRA because it really does help our market surveillance. I’ve added some useful links in there and please feel free to come and find me afterwards or ask any questions about what the MHRA has been doing.

Thank you.

Philip Davenport's presentation at the EBME Expo: The Role of the MHRA and Reporting Requirements