Self-certification seemed (and perhaps still seems) very appropriate for many of the products considered as medical devices (e.g. syringes and sterile gloves), and even for most diagnostic tests where the interpretation of the result of the test is always in the context of a plethora of additional information. However, as the medical world has changed, the potential risks to patients from devices and diagnostics have become more obvious¹, and the interplay between devices, diagnostics and therapeutics can pose particular risks to patients. Obvious examples over the last decades include: drug eluting stents; inhaler devices; implantable devices (ranging from surgical meshes to defibrillators) and the emergence of “companion” diagnostics. Additionally, today there are entirely novel technologies emerging such as therapeutic apps, whole genome sequencing and pre-implantation genetic testing, where potential harms are far from fully understood.

The need for tighter control of the approval processes, and an emerging understanding of the importance of actual clinical data (safety in use, clinical validity and clinical utility) both pre-marketing and post-marketing (surveillance) has led to considerable rethinking of how devices and diagnostics should be regulated in Europe, and the new and much more stringent processes were to be implemented through EU legislation. The Regulations on Medical Devices (Regulation (EU) 2017/745) (in force as of 22 May 2021 after a year’s delay) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) (intended to be in force as of 26 May 2022, but delayed for perhaps 3-5 years depending upon the risk category of the IVD) changed the European legal framework for medical devices. They introduce new responsibilities for the EMA and for national competent authorities (e.g. the MHRA) in the assessment of certain categories of medical device and diagnostic that may place patients at a higher risk of harm.²

Brexit has undoubtedly caused confusion but has opened opportunities for the UK. The Medicines and Medical Devices Act 2021⁶ gives much greater flexibility for the UK to make its own decisions regarding healthcare product regulation. It allows for an extension of the remit of the MHRA towards a more direct role in the regulation of devices and diagnostics. The first and most direct example of this was the decision to replace CE-Marking for devices and diagnostics with a UK equivalent, the “UK CA”- mark, which was supposed to be required for products on the market 1 January 2021.⁷ On 24 August 2021, the MHRA announced that this requirement has been delayed by two years and on 1 January 2022 it was confirmed that EU CE-marking would still be recognised in the UK until mid-2023.⁷ Amongst these various announcements, two matters stand out: first, that the new UK-CA seems very similar in its scope, requirements for evidence and for audit to the EU MDR and EU IVDR (perhaps not surprisingly since the MHRA was intimately involved in the development of these directives); and second, that Northern Ireland sits in a unique position in the UK where products may still require CE-marking. As of 30 June 2021, only two UK organisations had been accredited as “UK Approved Bodies” and were able to grant UK Conformity Assessment for devices and diagnostics with a third organisation having a scope limited to Conformity Assessment of IVDs for the detection of trisomy 21. Since the UK CA mark is not recognised in the EU, the benefits to manufacturers in obtaining the “UK CA” do not seem obvious.

In the context of this rather unsatisfactory background, the MHRA has proposed a wide-ranging change in the way devices & diagnostics are regulated in the UK, including significant changes in the role of the MHRA itself. In a positive move, the purposes and intentions of these proposals have been explained in detail and a process of public consultation has been initiated⁸, to which the MDDNTEG, and colleagues from the Policy and Communications Group and other groups within FPM, has submitted a detailed response.

Although FPM’s submission does very much support the broad thrust of these proposals, perhaps because they are so all-encompassing, a first reading might lead to the view that the UK could become a rather unwelcoming geography for the discovery, development and marketing of devices & Diagnostics. Some of the proposals seem to be rather ad-hoc (e.g. some of the suggestions regarding genetics tests, IVF, IT etc.) and don’t fit neatly into the broader thrust of the regulations. Others seem to recognise how burdensome much of these regulations might be to SMEs and academic institutes, suggesting that exemptions might be granted, or alternatives offered, including (perhaps self-defeating) alternative routes to the market (e.g. mutual recognition processes) and transitional arrangements. There is also a slight sense that some of the proposals are already a little out of date; for example, many genetics and genomics tests are readily available from providers ex-UK, and therapeutic and diagnostic apps invented ex-UK are easily downloaded onto smartphones. Sometimes as a nation, we tend to forget that we represent only 1% of the world population and that a large majority of life sciences R&D and manufacturing is conducted elsewhere.

MDDNTEG and FPM wish the MHRA well with their intentions to improve the public health (and the safety of participants in clinical trials) through these new proposed regulations and we hope our responses to several hundred probing questions, accompanied by detailed text commentary, will help in the evolution of regulations which will benefit health whilst supporting the UK’s life sciences industry.

At the Mad Hatter’s tea party, the time was always six o’clock and though Alice moved from chair to chair as she, the Mad Hatter and the March Hare moved places around the table, Alice never actually got any tea to eat or drink. We really hope the MHRA can make genuine progress with their intentions and that time does start to move forwards again!