Dr Laura Downey, Dr Rachael Dickson, and Prof Muireann Quigley
In September 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation seeking views on potential amendments to medical devices regulation in the UK. This is the latest activity in a two year period of uncertainty and flux. Amendments had been passed to maintain a continuing legal basis for medical devices regulations following Brexit, long awaited EU reforms were first mirrored then dropped late in 2020, and a dual system of regulation between Northern Ireland and the rest of the UK was introduced in line with the Northern Ireland protocol. The Medicines and Medical Devices Act (MMDA) was passed in early 2021 but provided little in the way of policy, instead establishing broad delegated powers for the Secretary of State to amend existing regulations.
The MHRA consultation hints at expected improvements, but a close reading of its content (and between the lines) indicates that some key issues may be left unresolved. With draft regulations expected in early 2022 there is still uncertainty ahead.
Enough Focus on Safety and Transparency?
Patient safety was a major sticking point of the MMDA during Parliamentary scrutiny; specifically, the framing of the delegated powers therein inadequately prioritised patient safety amidst other aims of the Act, such as market access. Although last minute amendments from the Government provided some improvements, arguably this issue remains of concern. The metal-on-metal hip and PIP implant scandals partially drove calls for reform which resulted in recent EU regulations (Medical Device Regulations (2017/745) (MDR) and the in vitro Diagnostic Medical Device Regulations (2017/746) (IVDR). During the drafting of the UK’s various EU Exit regulations, these EU changes were first adopted (Medical Devices (Amendment) (EU Exit) Regulations 2019), then withdrawn (Medical Devices (Amendment) (EU Exit) Regulations 2020). Nevertheless, with an already out of date regulatory framework, and systemic safety issues highlighted and criticised in the Cumberlege Review, the need for updated regulation to improve safety is clear.
The framing of, and questions contained in, the MHRA consultation suggests that there will be some important changes once new Regulations are laid before Parliament early this year. The tenor of the consultation is such that we would not be surprised if these were largely in line with what would have been done if the 2019 EU Exit Regulations had remained in place. Of particular note within the consultation was where views were sought on the need for more detailed essential requirements and the tightening of equivalence rules. The laxity of these within the current regime has been much maligned and widely viewed as one of the drivers of the aforementioned scandals. A key reason for this is that the current Regulations permit evidence of safety from existing devices to be used as evidence for new devices with ‘similar’ profiles. We say ‘similar’, because the reality is that devices may not be similar at all. It could be that only one component within a larger device is in fact equivalent or that over time progressively more changes to a device are made so that, down the line, the newer devices only bear a shadow of resemblance to the original device for which evidence exists/was presented. Following the consultation, this could change so that such evidence of equivalence is only permitted where the entire device is equivalent to that on which earlier evidence is based.
Increased documentation and reporting requirements for Approved Bodies (previously known as Notified Bodies) – who provide conformity assessments for devices – may increase to provide greater transparency. Again, Approved Bodies were heavily implicated in earlier device scandals as manufacturers would ‘shop around’ for those more likely to approve their product. However, it is not clear to what extent this problem will be addressed by the potential changes indicated.
The MMDA introduced a power to create a medical device database and the MHRA consultation begins to flesh this out by proposing a system for unique device identifiers (UDIs) and an accompanying database. This should, together with indicated proposals to introduce greater reporting requirements across the supply chain, increase traceability of devices and persons in whom they are implanted. Welcome as they are, the proposed changes seem exceedingly similar to the UDI system that had previously been set out in the 2019 Regulatory provisions mirroring the EU regulations (the MDR and IVDR).
Expanding Scope and Clarifying Definitions
Linked to safety concerns, the MHRA consultation also sought views on the potential up-classification of devices with similar risk profiles to medical devices, but which have no medical purpose within the definition of ‘medical device’. This would bring within regulatory control products such as coloured contact lenses and dermal-fillers.
Other potential changes to scope involve the definition of ‘intended purpose’. The current definition makes it clear that a device’s purpose is indicated according to the data supplied by the manufacturer on labelling and instructions for use. Additionally, for implantable medical devices it also requires that the purpose be that for which it is ‘suited’. The consultation suggests clarifying that ‘intended purpose’ be subject to an objective test; what an objective observer would think the intended purpose was based on the information provided by the manufacturer, not on what the subjective intention of the manufacturers is. Whilst such a change would simply replicate what MHRA guidance suggests ought to be done in practice, placing it on a statutory footing might ensure less room for creative compliance.
Software as a Medical Device
Clarification of definitions was also sought in the consultation in relation to software as a medical device (SaMD). We have previously highlighted how software fits uneasily within the medical device framework which was designed with physical products in mind and argued that definitional clarity is needed in relation to a number of facets of SaMDs. The consultation indicates that some progress here may be imminent.
A key ambiguity in this area is the question of what it means to ‘place on the market’. In a world in which software can be downloaded from anywhere in the world to anywhere in the world almost instantaneously, it is not clear at what point SaMDs can be said to be placed on the UK market. However, while the consultation sought views on how the concept might be clarified in order to capture SaMDs available via app stores and similar means, it provided no suggestions itself on how that might be done. It also did not address the implication – inherent to the current definition of ‘place on the market’ – that devices are offered and supplied in a commercial context. The consequence is uncertainty regarding this outwith such contexts; for instance, where SaMDs are developed and/or made freely available by community or patient-led initiatives, charities, or other entities that are not traditional manufacturers.
General opinions on the potential need for specific regulation for what it terms Artificial Intelligence as a Medical Device (AIaMD) were also sought. This is an area of growing attention, with the EU having recently released its own draft regulation. The UK Government has framed AI, and specifically AI in healthcare, as a key priority in their Life Science Sector deal and for their digital NHS policy in general. It will be interesting to see what may come of this down the line.
Continuing Uncertainty?
The MHRA consultation document indicates a direction of travel which will result in increased transparency and traceability of devices and more detailed essential requirements in relation to safety and performance. If many of the proposed amendments make it into draft regulations then there will be welcome improvements.
However, a large number of the proposed amendments are similar to – at times word for word – provisions that would have been in place had the 2019 EU Exit Regulations not been subsequently revoked. These by and large mirror the EU Regulations in the area, which raises the question as to why those provisions were removed in the first place. If these new recommendations are adopted without significant change after consultation, all that may have been achieved is a delay to much needed updates and the prolonging of regulatory uncertainty.
Still such uncertainty persists. The consultation proposals are just that, proposals. They may change depending on the weight of responses received. Further compounding this is the fact that the consultation proposals themselves proceed on the basis that the UK Government will work out a new deal with the EU on Northern Ireland. This is far from guaranteed and may mean a rethink of any draft regulations in the works, leaving us again unclear on the future extent of regulatory divergence between Northern Ireland and the rest of the UK.