A comprehensive overview of the changes proposed by the MHRA
Many of the proposals in the consultation would have the effect of harmonising UK legislation with the EU Medical Devices Regulation (EU MDR) and the In Vitro Diagnostic Medical Devices Regulation (EU IVDR) but there are some notable differences. In this article, we pick out five key areas worth highlighting.
1. Software as a Medical Device (SaMD)
The consultation contains a proposal to introduce an “airlock classification rule” to enable temporary early market access for SaMD with an unclear risk profile. During this period, the SaMD would be subject to enhanced monitoring and restrictions as if the product were a high risk medical device. This could function as a testing environment or “sandbox” while the product is fully evaluated. It is unclear who would be making determinations of when SaMDs could take advantage of this procedure or proceed fully to market – in practice it might be the manufacturer, the MHRA, or someone else entirely – but it could provide a significant opportunity for developers seeking to clarify the SaMD’s risk profile.
There is also a promise to clarify whether software available from App store or other websites is “placed on the market”. It is unclear whether the goal is to bring these platforms into the economic operator framework or to exclude them. It would be a genuine divergence from the EU position if the UK decides that App stores and similar platforms are economic operators rather than agnostic facilitators for people seeking to access to SaMD Apps. Such a decision would be likely to radically reduce the number of SaMD available to UK patients – and for this reason the MHRA would be brave to take this approach.
2. Transitional arrangements
The MHRA clearly aims to achieve proportionality in the transition to the new requirements introduced by the UK MDRs. The MHRA hopes to avoid the challenges that dogged the drafting of Article 120 of the EU MDR, which deals with transitional provisions.
The applicable transitional period will depend on the device risk class, and post-market surveillance requirements will apply throughout this period. The length of the transition period will also likely depend on the source of the current certification for a medical device – devices with a UKCA mark could remain on the market until 2025 or 2026, while devices with a CE mark would be able to remain on the market until 2027 or 2028 subject to an additional “light touch” assessment. Again, it is not yet clear who will carry out these refresher assessments.
One important observation is that a clinical investigation commenced before 1 July will be allowed to continue under the previous framework, but will be subject to additional reporting obligations.
3. Conformity assessment
The volume of devices that require a UK Conformity Assessment with an Approved Body will increase. This is for multiple reasons, including updates to the regulation of implantable devices and SaMD.
Our overall impression is that the proposals will reduce flexibility of the conformity assessment process. Manufacturers will no longer be able to apply to multiple Approved Bodies in the hope that one of their applications succeeds. Approved Bodies will be subject to a time limit for responding to conformity assessment applications. Technical documentation will need to follow an approved structure and be retained for a longer period, potentially 15 years for an implantable device.
4. Implantable devices
The consultation seeks input on restricting the supply of implantable devices in the hope of making sure that there is adequate scrutiny and patient focus in the sector. As well as limiting supply of implantable devices to specialist centres with specialist practitioners, there are also proposals requiring proactive follow-up with patients to whom such devices are administered. The MHRA also proposes to reduce or eliminate reliance on equivalence in the assessment of implantable devices.
Implantable devices seem set to follow the EU MDR, in so far as the acronym stands for More Data Required, with additional pre-market requirements for implantables compared to general medical devices in the same classification and a new requirement to provide information to practitioners on the management and use of obsolete models of implantable devices. These obligations, along with others proposed in the consultation, mean a substantial burden will be placed on the manufacturers of implantable devices (to an extent even greater than under the EU MDR), and we hope that they will not reduce the supply available to UK patients.
5. Alternative routes to market
The MHRA proposes three new alternative routes to market, which it hopes will improve the supply of devices into the UK and bring the UK system into line with global practice.
Since 2021, the UK has been an observer of the MDSAP (Medical Device Single Audit Program) – a programme whose members include the US FDA, as well as authorities from Australia, Brazil, Canada and Japan. Under this programme, a single regulatory audit of a manufacturer’s QMS can satisfy requirements in multiple regulatory jurisdictions. It is expected that UK Approved Bodies will act as Auditing Organisations under MDSAP, and that these assessments will be taken into account by the MHRA.
A further pathway to market would allow the MHRA to accept approvals from other international medical device regulators, subject to an abridged assessment by a UK Approved Body.
The third and most eye-catching new pathway is for “Innovative Medtech”. This pathway will be restricted to devices that meet certain criteria that are likely to include factors such as (a) the size of the patient population (favouring rare conditions and small patient groups); (b) the scale of the innovation (favouring devices that will be “game changers” for end users); and (c) the size of the manufacturer (targeting small and medium-sized enterprises). Under this pathway, the MHRA would grant interim approval allowing the manufacturer to make the device available on the market before obtaining a UKCA Mark for the device. The MHRA would partner with NICE and other key healthcare stakeholders so that reimbursement for manufacturers could be integrated in the process. The manufacturer would then have to switch to the main Approved Body route for UKCA marking and post-marketing surveillance. This is the closest equivalent of a conditional marketing authorisation for medicinal products in the pharmaceutical regulatory framework – in both cases, the full suite of data will eventually be required, and the pathway is limited to situations where an unmet patient need is identified.
Conclusions, opportunities and omissions
The MHRA has made it clear that it does not want the UK to be a “dumping ground” where defective or low-quality devices can be rubber-stamped, instead hoping that the jurisdiction can become a “proving ground” for high quality and innovative medical devices. The Innovative Medtech pathway and the other hybrid approval pathways are clearly an attempt to strike this balance. It is not clear yet how the new directions on implantables will affect this aim – will the focus on experienced practitioners and centres drive specialisation and advances in this area? Or will a smaller pool of experienced people impede progress?
It is also unclear why the MHRA has such a concern about equivalence and has sought in numerous areas to make relying on it more difficult.
We believe that the proposals strike a good balance between harmonisation and divergence. However, the responses to the consultation are not due to be published until April 2022 and until then policy positions cannot be considered final. The consultation is open until the 25th of November.
You can watch a recording of the webinar here: Bristows reacts: the future regulation of medical devices in the UK