This post discusses the Government’s response to the MHRA’s consultation on the future of medical device regulation.
In October 2021, the Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation on proposed changes to the Medical Device Regulations 2002. As we have written previously, the consultation comes within a period of flux for medical devices regulation in the UK. This changing (or as we contend below, not so changing) landscape includes the passage of a number of EU Exit Regulations (first introducing, then removing provisions mirroring the long awaited EU Medical Device Regulations and In Vitro Device Regulations), as well as the introduction of the Medicines and Medical Devices Act 2021 (MMDA). As we have also noted previously whilst the latter is now the primary legislation in this area, currently it is little more than a framework act empowering the Secretary of State to make secondary legislation in its target areas. And this is where the MHRA consultation comes in. The proposals in the consultation relate to potential new regulations to be made using the broad delegated powers contained in the Act. Whilst there is as yet no sign of these, the Government’s response to the consultation, published in June 2022, provides further insight into their intended shape.
As we will see, the Government’s response shows an intention to take forward improvements with respect to safety and transparency, whilst displaying a piece-meal approach which would better (but not completely) align the UK variously with aspects of EU and US medical devices regulation, as well as with some international standards. Despite this, and given the strong political pronouncements of change following Brexit, the overall landscape is uncannily familiar. The situation is (to our minds at least) best summed up by the French phrase ‘plus ça change, plus c’est la même chose’, meaning ‘the more things change, the more things stay the same’.
Safety and Transparency Revisited
The MMDA sets out 3 considerations to which the Secretary of State must have regard when using the powers of the MMDA to amend the existing medical device regulations. These are the safety of medical devices, availability of medical devices, and the favourability of the UK as being seen as a place to develop and supply medical devices. Improving safety, in particular, was an issue made all the more pressing by the publication, during the passage of the Bill, of the Cumberlege Review findings into the failings concerning sodium valproate, hormone pregnancy tests, and vaginal mesh.
In their response, it is clear that the Government intends to take forward a number of proposals, including more stringent essential requirements for medical devices and increased pre- and post-market requirements, in order to address safety considerations and meet public health objectives. Confirmed in the response are changes to clinical studies and performance evaluations. Amongst other things, these are to include more detailed requirements relating to informed consent and the conditions for inclusion of minors and pregnant women. There are also proposed changes to the requirements around the inclusion of participants in such studies in emergency situations where prior consent cannot be obtained. Device classifications are also to be subject to some change bringing different devices into higher risk groups. Specifically, vaginal mesh is being moved to a Class III device, something which is good news in light of the findings of the Cumberlege Review. Further, proposed changes to the scope of the regulations to include devices that do not have a specific medical purpose, but have a similar risk profile to medical devices, were met with a positive response from the Government. This includes devices such as coloured contacts and dermal fillers.
Of special note are the intended changes to the equivalence exception. Currently this exception allows devices that are similar to a previously approved device to use the (evidence relating to) the prior device as evidence of the new device’s safety. In practice, however, the exception was relied on even where only parts of devices were similar. The result is that over time a succession of changes means that eventually devices have been approved which bear little or no resemblance to the original approved device. The Government’s intention, as detailed in the response, is to tighten the rules regarding this so that only total equivalence (on clinical, biological and technical bases) of devices will engage the exception. If brought in, this will, according to the Government, represent a stricter regime than the reformed provisions in the EU MDR. The latter requires only that consideration be had to the similarity of devices such that there would be ‘no clinically significant difference in the safety and clinical performance of the device’. We shall need to wait to see the final draft of any intended regulations to assess whether and to what extent there is a difference between the two approaches.
Meanwhile, the Government’s commitment to the creation of a Unique Device Identifier (UDI) system and a medical device database have been affirmed in the response to the consultation. These are to be accompanied by increased requirements on reporting and post-market surveillance. Such changes should increase the traceability of devices and ensure that important information is not only captured but more easily accessed, something which came through strongly in the Cumberlege Review. However, it is also clear that the so-called database will be part of a series of integrated databases probably building around existing systems such as the Breast and Cosmetic Implant Registry and National Joint Registry created on the back of the PIP scandal and the 3M Capital Hip Implant Failure Report. As such, it is not clear how this integrated database will work or how accessible it will be in reality.
International and EU Alignment
Interestingly, the changes outlined above bear a striking resemblance to provisions in the EU MDR and IVDR. Changes in scope to include devices without a medical purpose, but similar risk profile and the upclassification of certain devices are both contained in the EU MDR. Likewise, the proposed UDI system, increased requirements relating to registration, reporting, and the conduct of clinical investigations and performance studies are all similar to provisions in the EU MDR. Given this, there are questions as to why, when we had provisions mirroring the main aspects of the EU MDR and IVDR in the Medical Devices (Amendment etc)(EU Exit) Regulations 2019, they were removed, only to seemingly be reconfigured as potential future regulations. That being said, there are points of departure in the intended changes.
Changes to the classification of in-vitro devices, as discussed in the Government’s response, are not to be in line with the EU IVDR, but with the international standards of the International Medical Device Regulators Forum (IMDRF). Meanwhile, many of the Government’s intended changes in relation to software as a medical device (SaMD) reflect international and US approaches intermixed with that of the EU MDR. A definition of software as ‘a set of instructions that processes input data and creates output data’ taken from the EU’s MEDDEV 2.1/6 is to be inserted into regulations. Additionally, extra essential requirements relating to cybersecurity (among others) are to be added akin to those in the EU MDR General Safety and Performance Requirements (GSPR) of Annex I para 17 and IVDR GSPR 16.4 as we highlighted in a previous post. The Government’s response also confirmed that they will indeed be exploring the introduction of Predetermined Change Controls Plans (PCCP) for software (again outlined in a previous post). This is similar to the approach being piloted by the FDA on a voluntary basis.
This mix and match approach, and the creation of regulation ‘fit for the future’ of software and artificial intelligence, is part of how the Government justifies meeting some of its obligations (set out earlier) under the MMDA; that is, to promote availability of, and for the UK to be a favourable place to develop, medical devices. Their approach stated at the outset of the response document is to align ‘with international best practice where this is to the benefit of UK patients and diverging only where advantageous to do so’. As part of this they also intend to progress with introducing alternative routes to market. These include the introduction of a pre-market approvals route to place innovative devices into service for a specified period of time in certain scenarios. Additionally, other pathways that utilise the Medical Device Single Audit Program (MDSAP) developed by the IMDRF, as well as a so-called Domestic Assurance Route which relies on approvals from other countries, have been mooted. These alternative routes to market may serve to increase availability of devices on the UK market and make it seem a more favourable to international manufacturers as a place to in which to supply such devices.
Increasing Divergence or More of the Same?
The piece-meal approach to alignment with ‘international best practice’ can be seen in light of the MHRA’s general aim to push for international alignment regarding medical devices. However, it is interesting that the bulk of the proposed amendments – that the Government has indicated it will take forward – closely mirror the position of the EU MDR and IVDR. Indeed some intended changes are, in places, almost word-for-word identical to their EU MDR and IVDR counterparts. Such alignment, together with the intended introduction of alternative routes to market for devices may go some way to ensuring that international manufacturers continue to place their devices on the UK market post-Brexit. But barriers will still remain, and it is not clear that there will ever be a reciprocal route to market for UK manufacturers in respect of the EU and other jurisdictions.
With respect to increasing safety, a hot button topic that dogged the passage of the MMDA, there are welcome strides being made; particularly in relation to stricter equivalence provisions which are set to go beyond those contained in the EU legislation. But even with this welcome divergence, the majority of changes aimed at safety were those that would have been brought in with the 2019 Regulations and via the EU MDR and IVDR. Given this, and as we have argued before, it is hard to understand why these important changes were removed from the 2019 Regulations only to be reinstated now. As we noted at the beginning, plus ça change, plus c’est la même chose!
Written by: Laura Downey and Muireann Quigley
Funding: Work on this was generously supported by a Wellcome Trust Investigator Award in Humanities and Social Sciences 2019-2024 (Grant No: 212507/Z/18/Z)