On 9 January 2024, the MHRA published a new Regulatory Roadmap, which sets out the expected timeline and key milestones on the way to the introduction of a new medical device regulatory framework for Great Britain. This long-awaited new framework will modernise the existing Medical Devices Regulations 2002 (UK MDR). Accordingly, we refer to the new medical device regulatory framework as the ‘Revised UK MDR’.

According to the two-page Regulatory Roadmap, the core of the Revised UK MDR is intended to enter into force some time in 2025. What the Regulatory Roadmap does not mention is that this represents a delay of around 12 months from the date on which the Revised UK MDR was previously intended to come into force, namely July 2024.

As we wrote previously, when July 2024 was announced as the target date for the entry into force of the Revised UK MDR, this also represented a delay of some 12 months. When the UK government first consulted on the introduction of a new medical device regulatory framework for Great Britain back in 2021, the expected date for its entry into force was July 2023.

Altogether, the Revised UK MDR is now intended to come into force two years later than when it was originally proposed. This is quite remarkable given that the public consultation back in 2021 indicated that the Revised UK MDR would effectively adopt the rules found in the EU’s then new Medical Device Regulation 2017/745 (EU MDR) and In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR).

This latest delay is frustrating as the modernisation of the UK MDR is long overdue.

To begin with, the UK MDR is based on the old EU medical device directives, which first came into force in the 1990s and have since been replaced in the EU and in Northern Ireland by the EU MDR and IVDR. The UK MDR is not well-equipped to cope with the proliferation of new and emerging medical device technologies, including such hot topics as AI systems and companion diagnostics.

Further, the UK MDR was forced to undergo a number of amendments to ensure that it continued to function following the UK’s exit from the EU. These amendments included a plethora of transitional provisions, the introduction of new concepts such as the UK Responsible Person, and various other changes to give effect to the Northern Ireland Protocol, which made Northern Ireland subject to the EU MDR and IVDR. The consequence of these eclectic amendments, hastily made, is that the UK MDR has become more or less unreadable. Certain individual provisions of the UK MDR are not even internally consistent with themselves.

Implications of the Regulatory Roadmap for the content of the Revised UK MDR

As well as indicating when the Revised UK MDR is now planned to come into force, the Regulatory Roadmap also refers to a number of milestone events which need to take place between now and 2025. Some of these milestone events are interesting and have implications for the eventual content of the Revised UK MDR.

First, the Regulatory Roadmap refers to extensive stakeholder discussions planned throughout 2024 on foundational topics such as:

• Scope and classification;
• Essential requirements;
• Obligations of economic operators;
• Quality management systems; and
• Clinical investigations.

It is intriguing that the MHRA considers these topics to be open. We had understood that the draft legislation for the Revised UK MDR would reflect the outcome of the public consultation in 2021 (i.e. reflect the rules found in EU MDR and IVDR).

To the extent that there are points requiring clarification, these should be a matter for regulatory guidance documents which could be produced after the Revised UK MDR is already in force. The need for so many stakeholder discussions at this stage might indicate that the MHRA intends to adopt a different approach to that indicated in the original consultation outcome. If so, the eventual Revised UK MDR could look quite different to the regulatory framework which we anticipated two or more years ago.

Second, the Regulatory Roadmap refers to a public consultation in late 2024 on ‘future enhancement regulations’. We have not seen any clear indication of what these consultations will entail. However, based on the contents of the Regulatory Roadmap, we can speculate as to what they will not entail:

• Matters which were included in the original public consultation on the Revised UK MDR back in 2021 – including those which were rejected in the consultation response. By way of example, the original consultation included unworkable proposals such as implantable medical devices only being made available via expert clinical centres of excellence;
• Matters which are the subject of stakeholder discussions on the future core regulations, including on international recognition;
• The AI Airlock regulatory sandbox.

With those broad categories excluded, it is difficult to think of any regulatory proposal which the MHRA has recently mooted which could be the subject of this public consultation. Conceivably, the MHRA could consult on placing the Innovative Devices Access Pathway (IDAP) on a statutory footing. It might also consult on a dedicated regulatory framework for AI medical devices or on special regulatory incentives for medical devices for orphan conditions or for paediatric populations.

While all of this is pure speculation, we hope that this is the kind of thing which will be the subject of the public consultation on the ‘future enhancement regulations’ for the Revised UK MDR. It would be very disappointing if the ‘future enhancement regulations’ only contained mundane matters which the MHRA did not manage to include in the core regulations.