UK medical device regulations - where are we headed?
The UK Regulatory Horizons Council recently published their report on the possibilities of UK medical device regulations after Brexit. Normally, any sane person wouldnât blink an eye about such a mundane and bureaucratic process - but actually, thereâs some serious ramifications.
Let me just set the sceneâŠ
Ever since Brexit (Jan 1st 2021) the UK has been adrift, floating on its own outside Europe, while still being geographically in Europe (a fact even the most hardened Brexiteers canât deny). Until that date, the UK followed EU guidance on how to approve and monitor medical devices - you know, the things that every single NHS hospital relies on to function. From rubber gloves to MRI scanners, every item in a hospital has been âapprovedâ by EU regulations, known as the CE mark. Without these regulations, we wouldnât know for sure of something was fit to be used safely on patients in their hour of need. Until Jan 1st that is. Ever since that date, the UK has found itself free from the shackles of bureaucratic EU red tape, now going solo, and able make its own rules. Except that the rules are kind of international, and not just European, and theyâŠerâŠwork. And theyâve just been updated to be even more stringent (the EU Medical Device regulations (MDR) superseded the EU Medical Device Directives (MDD) in May 2021, but us Brits werenât invited to that party). Instead, weâve reverted to the UKCA mark (the same name we used before joining the EU), except that it only applies to devices in Great Britain (so technically should be called the GBCA mark), and not in Northern Ireland which uses the CE mark because itâs still part of Europe, or the UKNI mark if you like, and⊠oh, it just gets too confusingâŠ
You see, the problem is that the CE mark (short for ConformitĂ© EuropĂ©en) has been around for so long (well, ever since 1st Jan 1973 when the UK voted themselves into the EU), that every âdeviceâ currently in use in the NHS has been through the CE process. Now that the UK has left the EU again, the CE process doesnât apply here (well, strictly speaking there is a transition until June 2023, but after that it definitely doesnât apply here). Once that happens, well, no-one knows. Which is the whole point of this new report.
So, why is this so important, you may ask? Well, dear reader, if the problem is not solved by June 2023, then the NHS will simply collapse, and doctors and nurses will be thrown back into the bronze age of medicine, limited only to their own hands and fingers, bits of paper and maybe the odd Excel spreadsheet. Without all of those lovely EU approved medical devices that weâve been used to for the past 48 years or so, the NHS simply cannot function. No rubber gloves, no MRI scanners, and no way of regulating them. Additionally, as the reportâs appendix A so observantly points out, by leaving the EU we have inadvertently cut off market access both ways for device manufacturers - no-one wants to go through regulatory approvals for both the EU and the UK as its far too expensive and time consuming. This will reduce import and export - something which Iâm sure no-one wants to see.
Of course, Iâm being hyperbolic. No-one is going to let the NHS collapse. Weâre coming up with our own Great British plans for Great British devices, naturally! I was one of many stakeholders asked to give an opinion on this so, letâs have a look at what the final report suggestsâŠ.
Recommendation 1: Focus on Patients
The RHC report is clear that patients, and their opinions, matter. It states first and foremost amongst its recommendations that âthe regulation of medical devices should be centered on the needs of patients, informed by patients, record outcomes that matter to patients, and provide evaluations that are understandable to patients.â
Fair enough. Patients are after all why any of us do medicine in the first place. I suspect this recommendation has come about due to previously widely reported nasty adverse side effects of some medical devices, namely PIP breast implants bursting and IUDs perforating organs. Unless a patient reports these events, then neither doctors nor manufacturers know about them, and everyone just carries on as usual. So, it makes sense to include the patient voice here.
However, not all devices are âpatient centricâ - does a patient need to be involved in the assessment of a new syringe, ECG machine or CT scanner? What insight would they give to the regulation of such devices, and how are we to ârecord outcomes that matter to patientsâ for these items? The RHC report states that this is to enable âstate-of-the-art surveillanceâ on medical devices - but little detail is given as to the mechanisms of how this surveillance is to take place, and how exactly patients are supposed to make their voice heard. Perhaps a new MHRA website or email address for disgruntled patients to contact? Or do the manufacturers have to take on this burden? Who would run that, what standards would apply, and what mechanisms would be in place to deal with the influx of feedback? This recommendation creates more questions than answersâŠ
Recommendation 2: INcrease MHRA funding
The MHRA (or Medicines & Healthcare products Regulatory Agency for short) is the UKâs regulatory agency, standing at armâs length from the government. Theyâre the ones who approved all those pesky vaccines that have recently saved us all from staying at home for eternity. Until Brexit, they had the relatively easy job of just saying âyesâ to devices approved in Europe. Now, however, they need to get serious and start approving their own devices somehow. Naturally we should increase funding to the MHRA! And how do you do that politically? Easy! First you defund it on the quiet, getting rid of 25% of its staff, then later loudly announce some âincreasedâ funding. But really you just bring it back to the same level it was at before. Simples!
Recommendations 3 and 4: Create more UK auditors
Pre-Brexit, UK and EU medical device manufacturers could take their pick of professional independent auditors (known as Notified Bodies). Since the MDR came into force, about 20 or so have been designated as âgood enough to approve CE marks for devices under the MDRâ. Of course, the UK never adopted the MDR, so UK manufacturers canât use any of those auditors. Instead, they are stuck with only 3 UK-based auditing groups (known as Approved Bodies, or ABs, under the UK legislation), and those guys are b-u-s-y, I can tell you. Some have 12-18 month waiting lists! It comes as no surprise therefore that the RHC report recommends that this bottleneck is reduced, by creating more ABs.
I canât help but think though that this is a self-created problem. By leaving the EU, and ergo the MDR and CE marking process, the UK cut itself off from the 20 or so Notified Bodies available for auditing new devices. It therefore seems odd to me that the recommendation is to create more UK ABs, rather than to just let existing EU NBs approve devices for the UK (to be fair Appendix C does suggest this as a possible mitigation).
Recommendations 5, 6, 7 and 8: Britain, Britain, Britain
These recommendations proudly state that the UK needs to place itself as a leader on the international stage, set itself apart, hoist the mainsail, enter uncharted territory and become a bastion of home-grown regulatory science! Rule Brittania!
Oh, but also consider maybe just joining in with the international efforts of the IMDRF because, yâknow, theyâve got this stuff pretty much figured out already, what with their MDSAP programme and International (ISO) Standards which literally every other country on the planet usesâŠ
Recommendation 9: use a spreadsheet
Here, we see the RHC come up with the very sensible idea of creating a database of approved medical devices, and assigning each device its own Unique Device Identifier. Genius! If only the MDR had thought of that! (Spoiler: they did).
The EU database (Eudamed) is due to come online shortly, once the Europeans finish their summer holidays. Oh, and over in America, the FDA have had a product database for eons and have been using UDIs since time began. But, yes, we should definitely have our own British version.
Summary
Iâll admit, Iâve been rather tongue-in-cheek about this whole thing so far. However, there are some serious points to be made. Firstly, itâs great to see that at least someone recognises the absolute cluster-f*&% Brexit has put us in. Secondly, itâs reassuring to know that medical device regulation is important and vital enough for someone to commission a report on what to do about it.
The thing is, we are desperately trying to dig ourselves out of a hole we dug for ourselves. And whatâs worse, this hole doesnât need to exist. I donât recall any slogans on buses telling the Great British public that EU medical device regulations were evilâŠ
I know, thatâs not a helpful statement - Brexit is real, its happened and we are stuck with it, but that doesnât mean that we need to completely reinvent the wheel. Yes, we âtook back controlâ - but in this case, I donât think we really should have. Maybe, just maybe, when it comes to patient safety, new medical devices, and maintaining critical supply to the NHS, we should instead lean on international frameworks and admit that, despite our political differences, the existing standards that have been in place for decades (and are constantly being updated by teams of international experts) are the safest and best way to ensure continuity, market access and patient safety. In this, we can not, and should not, go it alone.
Hardian Health is clinical digital consultancy focussed on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.
