Health law,Brexit and medical devices: A question of legal regulation and patient safety

Introduction

Medical devices are one of the relatively unsung categories of medical miracles with a huge impact on patient lives. From cardiac pacemakers to hip prostheses to pregnancy tests, the technology associated with these devices has improved and greatly facilitated individual health. ¹ However, over the last decade, some medical devices have been at the heart of major health controversies. The PiP silicone breast implant scandal provides one such notable example. ² Poly Implant Prothèse (PiP), a French company, manufactured breast implants. These were sold directly, or in some instances through intermediaries, having been rebranded across some 65 countries. PiP used industrial grade silicone rather than medical silicone in the production of its breast implants. A high level of ruptures of the implants subsequently took place.

In March 2010, the Agence Francaise de Securite Sanitaire des Produits de Sante decided to recall the implants from the market. It also suspended further market placement, distribution or use. The following month, the EU Commission informed Member States about the situation and asked them to put measures in place to prohibit market placement, distribution or use of PiP implants and to inform relevant healthcare professionals. Subsequently, civil litigation and prosecutions were launched. ³

More recently, reports have highlighted the risks of and potential harms from the use of metal-on-metal hip implants. ⁴ Initially when these were marketed, the National Institute for Health and Clinical Excellence (NICE) in the United Kingdom stated that clinicians who were advising patients on this should ensure that patients ‘understand that less is known about the medium to long term safety and reliability of these devices or the likely outcome of revision surgery than for conventional hip replacements’. ⁵ Safety concerns have subsequently been raised regarding the higher reported failure rates of the DePuy Pinnacle metal-on-metal hip implants. There were also allegations of ‘metal poisoning’. ⁶ Litigation is currently ongoing in the United Kingdom regarding these implants. In June 2017, the Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on follow-up and patient management with the aim of ensuring the swift detection of problems. ⁷ Recent controversy also relates to the use of vaginal mesh implants, called by some ‘the new Thalidomide’. ⁸ These have been used as a means of attempting to address incontinence problems caused after childbirth, but it is alleged that this led to major complications with the disintegration of the plastic mesh, or the device ‘cutting into’ organs. Common side effects have included chronic pain, infections, loss of sexual intimacy and, in some cases, women have been left unable to stand or walk properly. This area is currently under review by both the Scottish and English governments and in July 2018 it was announced that the use of vaginal mesh implants in England was suspended. ⁹ What these incidents graphically illustrate is that the safety of medical devices is clearly critical for patients. Consequently, equally critical are the regulatory mechanisms which are put in place to ensure such safety, along with the way in which clinicians make decisions regarding their use. Within this article, the focus is on the former issue.

The regulation of medical devices is one of the many areas of health law which will be impacted by the United Kingdom’s withdrawal from the EU. Currently, UK medical device regulation is structured through the prism of three EU Directives. ¹⁰ These are: first, Directive 90/385/EEC which concerns implantable medical devices, including such things as cardiac pacemakers. Secondly, Directive 93/42/EEC, a general Directive which concerns medical devices from blood collection bags, hip prostheses and powered devices. Thirdly, Directive 98/79/EC concerns in vitro diagnostic devices such as pregnancy tests and tests for transmissible disease.

Confidence in the regulation of medical devices at EU level was shaken by the PiP scandal. Nonetheless, while PiP can be seen as a catalyst for reform, in reality this scandal can be seen as part of what was and what remains a regulatory continuum. Review of EU law in this area was already underway from 2008, although it took almost a decade before two new EU Regulations finally came into force in 2017 to replace the three previous Directives. Implementation of the new Medical Devices Regulation is to be undertaken in 2020, while for the new In Vitro Diagnostic Devices Regulation, the implementation date is 2022. It is perhaps somewhat ironic that it is at the very time when the EU medical devices regulatory system is about to be tightened, that there is a risk due to Brexit that the United Kingdom may end up bereft of such a regulatory structure.

Brexit is already posing many major challenges for those concerned with health and social care (see further papers in this volume). ¹¹ This article provides the first detailed legal examination of the implications of Brexit for UK patients and the NHS in the context of the future regulation of medical devices. The second section considers current EU regulation of medical devices with a specific focus upon general medical devices regulation. The third section explores the options for medical device regulation post Brexit, the prospect of a Bonfire of the Regulations and the new EU Medical Devices Regulations and the impact of ‘deal’ or ‘no-deal’ scenarios. The article concludes by arguing that while the new EU system for medical devices regulation is not perfect, it nonetheless provides an important opportunity for restructuring device regulation and for facilitating safety. It is important to ensure that, as far as possible, we do not lose such an opportunity at domestic level post Brexit.

Regulating medical devices for quality and safety: The role of the EU

Prior to the EU’s involvement in the area of medical device regulation, the United Kingdom developed good manufacturing practice guidelines for the industry in the 1980s. ¹² In addition, certain devices were also regulated as ‘medicines’, including contact lenses and intrauterine contraception. ¹³ It was, however, the involvement of the EU which provided the major drive for regulation with different types of medical devices being regulated through EU Directives since the 1990s. ¹⁴ Nonetheless, there has long been a tension in this area between the pressures of the marketplace and those of safety. ¹⁵ As Hodges has argued, the EU system

can also be criticized on the ground that the jurisdictional basis of the legislation is that of the facilitation of trade rather than of safety. It is true that as with all New Approach legislation, the medical devices Directives state that the achievement of a high level of health and safety is mentioned in the preamble but this is not strictly [the](SIC) legal basis on which the legislation is founded. ¹⁶

In ascertaining whether quality standards are met, there can be difficulties concerning which standard it is proposed to apply. Currently, a manufacturer can select to be assessed by any standard, including those national standards which are in conformity with harmonized EU standards. ²⁰ This gives rise to a real risk of problems due to the diversity in regulatory standards.

In the case of some devices which are specifically ‘custom made’ for the sole use of a particular patient, CE authorization is not needed but further specific criteria are required including retention of documentation for the competent authority. Confirmation of compliance with essential requirements must be based on clinical data, typically the compilation of relevant scientific literature or an appropriate written report with critical evaluation. In some instances, a clinical investigation itself may be required and where this is the case, this would need to be undertaken subject to research ethics committee requirements. An example here would be the introduction of a completely new form of device into clinical practice where the components are previously unknown.

One concern regarding the medical devices approval process relates to that of transparency. Since 2007, there has been a requirement in the United States that trial studies and results concerning medical devices must be published by the US Food and Drug Administration. However, there is no such requirement under the Medical Devices Directive. The level of information required for device approval is also very different than that needed by pharmaceutical regulatory processes. In evidence submitted to the House of Commons Science and Technology Select Committee’s review of medical devices regulation in 2016 by the Centre for Evidence-Based Medicine, it was stated that the amount of clinical evidence needed for approval ‘could be minimal’ and that moreover, the fact that existing studies published in the literature were accepted was ‘one of the main drivers of poor quality under-researched devices on the market today’. ²¹ Similarly, the Faculty of Pharmaceutical Medicine of the Royal College of Physicians expressed concern about the use of equivalence data and that unpublished safety issues could have arisen in relation to devices already certified. Devices may be produced with ‘subtle differences’ but not requiring new authorization meaning that certain safety/effectiveness issues may not as a result be explored. In addition, as the Faculty commented

as time goes on each iteration of a device rests its case on a previous iteration, each a little different to the next one, after several years devices may be approved that are very different to the original marketed devices. ²²

At present, there is some engagement at EMA level between devices and medicines regulation. This is firstly because the EMA does have the role of providing scientific opinions regarding the quality and safety of medical devices which include medicinal substances where these can have an ancillary action on the patient’s body. In these cases, the notified body is required to consult the EMA for a scientific opinion. Secondly, there is also an ad hoc European Medicines Agency/Committee for Advanced Therapies and Medical Devices Notified Body (EMA/CAT-NB) Collaboration Group concerned with the facilitation of some parts of Regulation (EC) No. 1394/2007, which deals with advanced therapy medicinal products. ²⁶ Such products may be a gene therapy medicinal product, a somatic cell therapy medicinal product or a tissue-engineered product. ²⁷

What could appear to be an obvious solution would be to totally align the processes for pharmaceuticals and for medical devices. ²⁸ This would provide the EMA with oversight and this could be matched by independent oversight from the competent authority at member state level – for the United Kingdom, the MHRA. However, those involved in the medical device industry have been strongly opposed to this. It is the case that there are some practical distinctions between drugs and devices which inevitably impact upon the precise manner in which their safety is reviewed. So for example, it can be argued that clinical trials concerning drugs are simply and inevitably practically different – put bluntly, it is easier to stop a participant taking a trial drug than to remove an implant. Moreover, as devices are designed to last several years, follow-up of a device during a trial would take considerable time. In contrast, the MHRA has commented that the use of notified bodies needs to be seen in the context of the sheer scale of the medical devices market with at that time there being some 400,000 devices across the EU. ²⁹ The MHRA also saw an advantage in that notified bodies could ‘specialise in certain areas and react to market demand adding expertise and capacity when required, which would not be possible for public sector bodies’. ³⁰

While the use of notified bodies can be seen as a practical compromise, nonetheless concerns have been rightly identified over many years as to the lack of conformity in approach taken by such bodies across jurisdictions. The number of such bodies varies between Member States. That is not by itself necessarily a problem, given that this may be reflective of different demands for approval from state to state. More worrying is that evidence has emerged over time of a lack of consistency in decisions taken by oversight bodies and questions as to the effectiveness of the oversight of such bodies. In addition, manufacturers have the ability to ‘shop around’ between notified bodies. They are able to select which body to approve their device rather than approval being entrusted to a national regulator. This practice is made easier by the fact that there is no central database that records approvals. ³¹ This gives rise to the very real risk that if some bodies are less rigorous than others, certain less scrupulous manufacturers may decide to target them. In addition, there is evidence that some notified bodies have been prepared to act as consultants to companies to assist them to get approval, when in fact they are not allowed to do this. ³²

In the wake of the PiP scandal investigations, a Joint Action Plan was established between the EU Commission and the EU Member States in 2012. ³³ This focused upon the functioning of notified bodies, market surveillance coordination in relation to vigilance and transparency and communication. ³⁴ Member States were requested to reinforce market surveillance ³⁵ and also to better coordinate their activities. ³⁶ Voluntary joint audits were undertaken of notified bodies by teams drawn from Member States and the Commission. While some good practice was identified, concerns were also raised as to the operation of notified bodies. ³⁷ These included notable variation in internal audits and follow-ups, limited or no procedures to deal with conflicts of interest, ³⁸ evidence of poor documentation and delays, ³⁹ inadequate information supplied to the Commission ⁴⁰ and diversity in the nature of liability insurance required. ⁴¹

Subsequently, the number of such bodies has dropped from some 80 to 56. ⁴² Some certificates already awarded were withdrawn as a result. Measures were introduced with the aim of addressing some of the problems highlighted in this audit process. In 2013, a Commission Implementing Regulation was introduced, intending to clarify the criteria that were required by notified bodies. ⁴³ Joint audits are now mandatory for new designations and for resignations of notified bodies. The Commission introduced monthly vigilance teleconferences with Member States. In addition, trends concerning safety-related incidents are now under examination by the EU Commission’s Joint Research Centre in Ispra. As we shall see below, the new EU Medical Devices Regulations will further tighten regulatory processes, but real concerns remain regarding the fact that the approvals themselves are left to private sector bodies.

Finally, one common method of EU regulatory oversight is the use of databases enabling pertinent information to be made available across Member States to facilitate safety vigilance processes. In the context of medical devices, the current database, EUDAMED, was established in 2010 and became operational from 2012 with Member States being required to enter all data into this by that date. ⁴⁴ Information stored in the database includes that relating to manufacturers, authorized representatives and also certificates. It also contains some basic data on vigilance and clinical investigations in the form of the title of the protocol and the primary objective. This provides an important source of information though as the PiP scandal demonstrates its operation does depend upon effective cooperation by notified bodies.

The UK regulation of medical devices is thus underpinned by EU law; however, various aspects of this regulatory process can be seen as problematic at present. Could Brexit, with its prospect of decoupling from EU regulatory regimes, provide potential opportunities with the development of a new specific United Kingdom-based scheme or will Brexit itself cause potential risks to patient safety in this area in the future? We consider these issues below.

Medical devices regulation and the Brexit effect

At the time of writing and following the Article 50 notification issued by the United Kingdom to the EU in 2017, the United Kingdom is due to leave the EU at 11 p.m. GMT on 29 March 2019. There has already been considerable concern expressed by those working in this area as to the impact that Brexit may have on the operation of medical device regulation in the future. The regulation of medical devices and the industry around it has clearly been seen as a matter of some importance by the Government. ⁴⁵ However, as with many issues concerning Brexit, its precise impact remains a matter of considerable uncertainty. This section considers the effect of the possible legal alternatives flowing from Brexit. A number of issues are examined in turn. Will this in principle be seen as an area for continued regulatory alignment, or one for a ‘Bonfire of the Regulations’? Secondly, if continued and future alignment is sought, then how can this be achieved? Here, the new EU Devices Regulations, which will be fully implemented in 2020 and 2022, respectively, are discussed in relation to the impact of a ‘deal’ or ‘no-deal’ scenario between the United Kingdom and the EU.

Is it likely that the area of medical devices is one which will be subject to a ‘Bonfire of the Regulations’? As with other aspects of Brexit, this may be viewed by some as a very real opportunity to decouple from EU regulatory processes. In the past, there have been suggestions by some UK Government ministers that certain EU Regulations in the area of healthcare can be seen as inhibitors of scientific development, for example, in the context of clinical trials. ⁴⁶ In an article in the British Medical Journal (BMJ), it was reported that George Freeman, the UK Life Sciences Minister whose brief includes the MHRA, had written to Carlos Moedas who is the EU Research, Science and Innovation Commissioner. He asked him to ‘tackle the increasingly precautionary “anti-science” trend in EU legislation’ as this could be seen as deterring investment. Concerns as to such an approach were highlighted in the same BMJ paper by Martin McKee, Professor of European Public Health at the London School of Hygiene and Tropical Medicine and a leading international authority on EU health regulation, who stated that

Once again the European Union is prioritising patient safety over the narrow interests of industry, protecting us from the policies pursued by our own government. We give up this protection at our peril. ⁴⁷

The new Medical Devices Regulations and the potential implications of deal or no deal

If alignment is sought with EU medical devices regulatory processes, then how can this be achieved? The UK Government is seeking a transition period as part of its Withdrawal agreement. Initially, it indicated that it wanted an agreement with the European Union which would include a 2-year transition period. ⁵¹ However, the EU took a slightly more restrictive approach and currently the transitional period is due to end in December 2020. ⁵² If that remains the case and forms part of the final agreement, then the United Kingdom will remain subject to existing EU law during this period and furthermore will need to comply with new EU law which is to be implemented during transition. This raises important practical issues due to the fact that a new EU Medical Devices Regulation is due to be fully implemented in 2020 (discussed below). Moreover, as will become clear, full compliance will require reciprocity which will necessitate an agreement to be reached with the EU.

First, the aim of the European Union (Withdrawal) Act 2018 is to transpose existing EU law into UK law. Thus legal continuity is intended to be assured and medical devices regulation within the United Kingdom itself would appear to be able to continue to be undertaken by notified bodies as at present. The 2018 Withdrawal Act only translates certain provisions and, by itself, cannot address a number of practical problems which are likely to emerge in such a situation. Unless there are specific sectoral agreements being made with the EU, the United Kingdom will be unable to participate in those parts of the Devices Directives and, subsequently, Regulations in the future which require reciprocity and cross-EU collaboration. Indeed, the existing Withdrawal agreement expressly precludes the United Kingdom’s participation in EU computer databases post Brexit. ⁵³ Without a special agreement, the United Kingdom would be unable to access EUDAMED. ⁵⁴ The United Kingdom would be excluded from existing vigilance systems. The decisions made by notified bodies would no longer be automatically recognized in other EU Member States, as we would have third country status at that point. Thus, attaining an additional specific agreement concerning medical devices is likely to be of great importance.

Secondly, there is the question of compliance with new EU law provisions during the transition period. This is a major concern regarding medical devices and it is likely to come into sharp relief because two new EU Regulations have come into force to replace the existing Devices Directives. The new EU Regulations that are due to be implemented post March 2019 are Regulation EU 2017/745 of the European Parliament and the Council of 5 April 2017 on medical devices ⁵⁵ and Regulation (EU) 2017/746 of the European Parliament and the Council of 5 April 2017 on in vitro diagnostic medical devices. ⁵⁶ If we move into transition then we will have to comply with the medical devices regulation which is due to be implemented in 2020. In contrast, the in vitro regulation does not have to be implemented until 2022. But if the United Kingdom were within a transitional period we would be expected to comply with the Regulations but this would require agreement from the EU that we would continue to for example access EU vigilance systems. A specific deal concerning devices therefore becomes critically important.

First, what are the differences between the existing Directives and the new Regulations? What is notable is that they build upon the approach taken by the Directives, while at the same time evolving and tightening the regulatory processes. As with the Directives, the final form of the Regulations can be very much seen as a compromise between considerations of business and regulation. The Commission stated that such regulation

Should be supportive of innovation and the competitiveness of the medical device industry and should allow rapid and cost-efficient market access for innovative medical devices, to the benefit of patients and healthcare professionals. ⁵⁷

Rather than a wholly radical reframing of the law, the Regulations build upon the current approach with continued requirements for CE marks, ⁵⁸ the use of notified bodies and an oversight body for notifiable bodies at member state level. However, in some respects, they do expand the scope of regulation. Critically, higher risk devices such as those in Class C III for medical devices will now be subject to much stricter pre-market review than was previously the case. For in vitro devices, some 80–90% will now need to be subject to a conformity assessment. ⁵⁹ Manufacturers will have to supply information drawn from systematic clinical investigations to notified bodies. These are required to identify the safety and the performance of the device and, in addition, have the task of establishing its ‘clinical benefit’. ‘Clinical benefit’ is defined as being the positive impact of a device on an individual’s health, which is determined by reference to what are meaningful, measurable and patient-relevant clinical outcomes. For some time, there has been concern in relation to the safety of certain cosmetic procedures, notably the use of facial fillers. Certain new aesthetic devices, which have the same risk profile and characteristics as medical devices, are now included under the Regulations. Where products combine medicinal product and devices, these will also now need to be assessed under the marketing authorization criteria for medicinal products.

In the past, there has been concern in relation to the diversity in standards applied when assessing medical devices. ⁶⁰ The Regulations are driving towards alignment of approach. The EU Commission is to establish panels of experts to advise on whether a high-risk device should be approved who will be organized through the EU Joint Research Centre, a specialist EU research unit based in Ispra in Italy. ⁶¹ The expert panels will operate on an ad hoc basis and will comprise volunteers. Concerns remain as to whether sufficient resources will ultimately be devoted to this task, and how effective these panels will be. ⁶² As Professor Alan Fraser commented in evidence to the House of Commons Health Select Committee in January 2018, the group in DG Grow concerned with devices and the staff at the Joint Research Centre are currently limited in numbers

these two groups have few staff dedicated to medical devices (recently the total was less than 15 whole-time equivalents, but it has been projected to increase to more than 30) and their number includes very few technical specialists (recently, there were only 2 medical doctors). ⁶³

A new procedure has been developed to deal with cases where it is intended to undertake clinical assessments in more than one Member State. This will work initially on a voluntary basis, but 7 years from the implementation of the Regulation Medical Devices, the procedure will become binding. This will enable a single application to be made for assessment, something which potentially will work towards greater centralization and standardization of processes concerning medical devices than exists at present. This would potentially provide the first steps towards aligning the structure of centralized processes for drugs and for devices.

The new Regulations also use a common EU regulatory approach in the area of health law, that of the ‘qualified person’. ⁶⁵ Manufacturers must ensure that a person is responsible for regulatory compliance, conformity and post-market surveillance. ⁶⁶ This person is required to have specific expertise, including the requisite university-level academic qualifications and scientific or regulatory experience. ⁶⁷ In the case of very small businesses, they will not have to have such a person on their staff, but they will need to have access to them. ⁶⁸ Alignment with EU standards would require such persons to be employed post Brexit. But if the United Kingdom leaves the EU, it is possible that some existing notified bodies in the United Kingdom may decide to relocate and, as a result, those individuals with highly specialized qualifications in this area may also decide to seek employment in notified bodies in other EU Member States. This could adversely impact the operation of such bodies and their business models.

A further concern raised in relation to the safety of devices is what would happen when things went wrong and the nature of liability of manufacturers for their devices, something brought into sharp focus by PiP and other ongoing litigation. The new devices Regulations introduce the role of the ‘sponsor’, something which has been included in the scrutiny of clinical trials on medicinal products both in the original EU Clinical Trials Directive and also the new Clinical Trials Regulation. ⁶⁹ The sponsor is a ‘backstop’ in terms of liability and accountability. The Regulations also require that there is the need for sufficient financial coverage in relation to manufacturers’ potential liability. ⁷⁰ These are notable steps forward, but they do not provide a panacea. There is no requirement for a Member State to set up a specific compensatory system in relation to the potential harms resulting from such medical devices. This is an issue which requires greater consideration at domestic and EU level. ⁷¹

The Regulations include a range of other new safety-related measures, including requiring manufacturers to produce an annual safety report along with tighter reporting timescales for vigilance information. ⁷² Traceability is another common regulatory strategy utilized in European Health Law. Tracking and tracing is used in the context of tobacco regulation and in relation to tissue and cells through the Single European Code enabling identification of material. ⁷³ This approach is now being introduced in relation to medical devices. Distributors and importers are required to cooperate with manufacturers in relation to the traceability of devices. ⁷⁴ In addition, there will be a unique device identification (UDI) system to enable the traceability of devices, ⁷⁵ linked to a new UDI database accessible to the public free of charge. ⁷⁶ Manufacturers will be required to include devices, other than custom-made devices, in this database. ⁷⁷ Without a specific agreement, the United Kingdom would not have access to this database.

The existing EUDAMED approach will be continued and extended through an expanded computer database. ⁷⁸ This will enable information to be added in relation to the registration of devices, economic operators, UDIs, notified bodies and clinical investigations and so on. There will also be a new central registration database which will be interoperable with the new Clinical Trials Database. This database is being introduced in 2019 as part of the implementation of the new EU Clinical Trial Regulation (which is replacing the EU Clinical Trials Directive which currently regulates trials on medicinal products). This bringing together at least one further part of pharmaceutical regulatory approaches can be seen as symbolically very important. While devices have for many years been treated separately and while the EMA is not a central regulator, nonetheless, this in the future may be regarded as an important step in bringing the regulation of pharmaceuticals and devices together. Again, the United Kingdom will not have access to these new databases without a specific agreement being negotiated to apply after we leave the EU.

One feature of pharmaceutical regulation has long been that of patient information. The Pharmaceutical Directives led to information being provided to patients via information sheets having to be included in marketed packs of medicines. ⁷⁹ Greater information provision can be seen as a means of facilitating patient consent to treatment – something which at EU level is included as a requirement in the EU Charter of Fundamental Rights. ⁸⁰ This approach is now being developed in relation to medical devices through the requirement of the provision of an ‘Implant card’. ⁸¹ This will provide information regarding implantable medical devices for patients. It can be seen not only as following the trend in pharmaceuticals but also the lack of information provided in the past to patients with PiP implants. Patients will be given enhanced information regarding technical specifications including information in relation to the UDI, the serial number of the device, whether devices will be affected by security scanners and the life of the device itself. Information is to be made available in a comprehensible manner, updated as needed and will be available to patients via a website. ⁸² This can be seen as a very important development for patients, particularly in the light of the recent confirmation from the Supreme Court in Montgomery v. Lanarkshire that informed consent is part of English law and that a dialogue between a doctor and a patient is a necessary part of this. ⁸³ It can be argued that disclosure of the risks of treatment should include such information in relation to technical specifications. The implant card can be seen as something which can effectively be built into the consent process. The EU’s engagement with and requirement of the provision of such enhanced information to patients could frame future judicial understanding of what a responsible patient (and what this particular patient) would want to know about the implications of their medical treatment where that treatment includes a medical device. Both the implementation of these provisions and continued future alignment can be seen as particularly important to ensure that patient choice is facilitated in the future.

What will be the impact of Brexit upon UK implementation of these new EU Regulations? In the case of a Brexit transition period, the United Kingdom would need to align and participate with these developments concerning the general Devices Regulation, due to be fully implemented in 2020 (though not the In Vitro Devices Regulation which will only be fully implemented after 2022). There is a further complexity here which is that, at the present time, the MHRA has already advised that as it is the case that the Regulations are in force, albeit full implementation is not for some time, some firms may decide to have their devices approved under the new Regulations. ⁸⁴

This, however, only takes the implementation of medical devices so far. As we have seen, unless there is a specific agreement either in relation to the transition period or subsequently, the United Kingdom stands to lose a range of benefits which it currently possesses, and which it would normally have had access to through the implementation of the new Regulations.

What could then be done to address this issue? The July 2018 White Paper suggests the prospect of an ongoing Association Arrangement between the United Kingdom and the EU, with provision for ‘regular dialogue between UK and EU leaders and ministers, commensurate with the depth of the future relationship and recognising the significance of each other’s global standing’. ⁸⁵ It is envisaged that in some situations, the United Kingdom will remain part of a ‘Common rulebook’ so that products should only have to be tested in one market – United Kingdom or EU – to be recognized. The intention is that this would be accompanied by adherence to compliance frameworks’. The 2018 White Paper also makes reference to conformity assessments and necessary labels/marks which would, it appears, include the CE marking. It is also envisaged that conformity assessment bodies would be accredited and there would be adherence to manufacturing and quality assurance processes. The White Paper also proposes continued recognition of approvals completed before the end of the implementation period itself. ⁸⁶

This approach appears to be in line with that of ‘mutual recognition’. Switzerland provides one example of a non-EU Member State where there is agreement to facilitate regulatory alignment in relation to medical devices. A mutual recognition agreement (MRA) operates by setting out conditions under which the non-EU country will accept conformity assessment results undertaken by EU conformity assessment bodies to show compliance with the non-EU member’s country, and vice versa. ⁸⁷ Such agreements include relevant lists of designated laboratories, inspection bodies and conformity assessment bodies in both the EU and the third country. There are also MRAs for medical devices between the EU and Therapeutic Goods Administration of Australia, and with New Zealand and Canada. This does depend upon negotiations and consequent financial agreements reached in relation to access. It remains uncertain as to whether the EU will be prepared to support this type of agreement. Nor does it seem aligned with the approach currently sought by the United Kingdom which appears to be a sectoral deal hybrid approach which would enable us to retain involvement with the EMA and consequent participation in EU databases. Thus, while the United Kingdom appears to be moving in this direction as to how it wants to proceed in negotiations, whether this option will prove realistic to attain is very unclear.

There are, as have been outlined, a myriad of remaining uncertainties dependant not only on the negotiations, but also on the willingness of the UK Government to continue to align longer term with the regulatory standards in this area. Medical devices regulation is currently undergoing a major revision. The United Kingdom can unilaterally, if it chooses, align with various parts of the new EU Medical Devices Regulations. However, without an agreement, the United Kingdom will be excluded from the EU networks, databases and mutual recognition processes, and agreements between the EU and United Kingdom will be needed to cover both transition and post-transition for this to be the case. It remains, of course, uncertain whether such an agreement will be possible. Some may see Brexit as an opportunity for regulation to enable the establishment of new approaches in this area in the future. The concluding section examines whether Brexit could provide potential for a new regulatory approach.

Conclusions

The implications of Brexit for health law in the United Kingdom in general and on medical devices in particular are riven with uncertainty. ⁸⁸ Nonetheless, there is a possibility that some may see the withdrawal from the EU as an opportunity to reframe medical devices regulation and, indeed, rather than reduce regulation recognize the potential to provide more rigorous scrutiny than that which is currently applied. As noted above, medical devices regulation is complex and its effectiveness is a matter of controversy and, while reforms are being introduced, it can be argued that they do not yet go far enough. If there was a ‘no-deal scenario’, this could potentially allow the United Kingdom to introduce quite major reforms at domestic level. The UK Government could decide that in the light of the complexity of the regulatory system and the concerns in relation to safety thrown up by the PiP, metal hip implants and vaginal mesh controversies, what is needed is a radical revision of the system. It could decide to move away from the current decentralized system with its myriad of private ‘notified bodies’ and instead move towards a centralized regulation system. This was rejected when the EU considered reform of the various medical devices directives, but the United Kingdom could decide to take this forward at domestic level. Either a new Medical Devices public regulatory body could be established ⁸⁹ or, alternatively, this role could be entrusted to the existing MHRA. Were the MHRA to be given this role, it would of course need to be accompanied with enhanced staffing and financing. Giving this task to the MHRA would have the advantage that decisions regarding approvals of medical devices were entirely entrusted to an independent regulator rather than a commercial company, which could help to restore public trust. While this would clearly involve fairly extensive costs, particularly in the initial establishment phase, it could be argued that these could be seen as appropriately proportionate in terms of ensuring safety in relation to medical devices. The new Agency could take forward the beneficial aspects of the existing EU schemes, such as the implant card and tracking and tracing of products. This would not, however, address the question of reciprocity. Unless there is a separate sectoral agreement, the United Kingdom would still be excluded from the cross-EU recognition of device approval and from the ability to share information as part of vigilance activities. Whether access would be allowed to the full EU databases themselves remains questionable at present. A new UK regulatory scheme could also address the concerns noted above in relation to compensation for medical devices. It could, for example, establish a specific no-fault compensation scheme in this area, but in reality given the unwillingness to introduce such schemes generally in the United Kingdom (with very limited exceptions), this is unlikely to be taken forward, at least in the near future. ⁹⁰

While such an entire reframing of medical device regulation itself may provide an effective solution in the long term, there are several reasons why this particular option is very unlikely to be taken forward by the UK Government. The first is clearly that of time. Unless the clock is stopped on Article 50 and/or unless there is a much longer transitional period negotiated than currently envisaged by either of the parties to the negotiations, the UK Government’s role in relation to regulation up to Brexit will be concentrated on ‘firefighting’ across a range of fronts. As we have seen in relation to devices, and this is a problem across all other sectors, not simply health, a vast range of matters will need to be resolved before we leave to ensure effective operations of systems which cannot be resolved by the European Union (Withdrawal) Act 2018 itself. This is simply not the time for a calm and considered thorough domestic overhaul of the medical devices regulatory system. What the Government has indicated in the technical notices published in August 2018 in preparation for a no-deal scenario is that it is currently working on contingency plans for supply of such devices. ⁹¹ It has indicated that in the case of a no-deal arrangement, the United Kingdom will continue to recognize CE-marked devices approved for the EU market at least initially, and there will also be consultation ‘in due course’ as to what happens after this initial arrangement. ⁹² Moreover, the MHRA would not be able to provide oversight for notified bodies as at present. It is intended that the MHRA would take over national decisions as to post-market surveillance. The intention seems very much for an approach, at least initially, of a holding operation and continuity.

Secondly, even if time was not a factor, there would be a further practical problem here. There has been a steady trend over the last two decades by UK Governments to reduce the number of arm-length bodies as a means of reducing cost. ⁹³ This current Government has shown no signs of reversing this trend, nor is it noted for taking forward the introduction of new regulatory regimes in the area of healthcare (in contrast to the previous Labour Government with, e.g., its introduction of groundbreaking regulation in the area of human material through the Human Tissue Act 2004). Without the necessary political will, the prospect of the creation of alternative regulatory bodies and bespoke new innovative regulatory structures in relation to medical devices is likely to simply remain within the pages of academic journals and not to enter the statute books.

The best-case scenario at present to help reduce future risks to patient safety will be for the United Kingdom to align with the new Medical Devices Regulations. This will require active continued alignment during the transitional period in relation to the General Devices Regulation. In the subsequent period after transition, it would be necessary for the United Kingdom to ensure compliance with the new In Vitro Regulation which is due to come into force in 2020. In addition, the UK Government should explore the prospect for a sectoral deal relating to devices and pharmaceuticals. Given the existing EU negotiation strategy, this may prove ultimately impossible, and if that is unsuccessful, a MRA should be sought. The Government should also attempt to ensure ongoing liaison with the Joint Research Centre and Expert Working Groups developing standards in this area and seek an observer role on the new Medical Devices Coordination Group which the EU is establishing. Such proactive steps to facilitate regulation are critical. As we have seen in relation to PiP, vaginal mesh and metal hip implants, we simply cannot afford to be complacent about the risks that medical devices can pose to patients. The recent EU initiatives demonstrate that there is a real need to ensure that standards are not reduced. As elsewhere, patient safety is a critical factor in a healthy Brexit.