Article by Hill Dickinson
Authors are Jamie Foster (Partner) and Jasmyn Spanswick (Trainee Solicitor).
Earlier this year we published an article considering the regulatory landscape for medical devices as it then was. Since then, we have seen a new Government and even more developments culminating most recently in the release of new draft regulations. The regulatory landscape for medical devices is undoubtedly fast-moving. Here we summarise the latest developments and consider the impact of these for those in the sector.
MHRA Roadmap updates
Following the election in July, the Medicines and Healthcare products Regulatory Agency (MHRA) published an update on plans for Med Tech regulatory change, announcing that the ‘shape’ of the roadmap announced in January 2024 will largely remain the same, with the only differences being in the timings and some of the detail. The MHRA is currently working on a revised roadmap for publication before the end of the year that will outline these differences. The intention is to update the current regulations through statutory instruments (SI) – a Post Market Surveillance SI now having been released in draft and a Pre-market SI due to be released in 2025.
Post Market Surveillance regulations
The draft Post Market Surveillance Statutory Instrument(PMS SI) is the first major update to the framework of medical device regulations. This draft introduces regulations on monitoring and reporting devices once they are on the market. The clearer and more robust measures have been introduced to improve patient safety and reduce adverse incidents by requiring manufacturers to identify and address issues earlier.
Risk-proportionate requirements should also facilitate greater traceability of incidents and reporting trends, as well as encouraging further growth and innovation within the sector. The MHRA hopes that comprehensive guidance aimed at providing manufacturers with support with both implementation and compliance will be published once the Parliamentary process has concluded with the draft being approved. There is then a proposed six-month implementation period meaning that the regulation will likely become law in Summer 2025.
Pre-Market regulations
In its update on plans for Med Tech regulatory change, the MHRA also outlines its plan to introduce Pre-Market regulations to improve both patient safety and access. We understand that drafting of the Pre-Market statutory instrument is already well advanced and includes:
- measures increasing the classification and therefore the level of scrutiny of medical devices, to increase patient safety;
- measures introducing a legal requirement for unique device identifications (UDIs) to make it easier to identify products where there are concerns about patient safety;
- a requirement for manufacturers of implantable medical devices to provide ‘implant cards’ to patients; and
- new rules on what can be claimed publicly about a device.
These new measures are in response to the Independent Medicines and Medical Devices Safety review and are intended to enable the whole health system to better protect patients. Multiple checks and balances still need to take place however before this SI can be laid in Parliament.
A consultation is also expected before the end of 2024 where additional measures to improve patient access will be considered. The consultation will cover proposals such as taking account of decisions made by comparable regulators when deciding whether products should be used in Great Britain and proportionate regulation of In Vitro Diagnostic devices (IVDs) to enable earlier action to delay or prevent the need for treatment.
The results of the consultation are intended to be published at the beginning of 2025. The MHRA intends to publish the full text of the Pre-Market SI by Spring 2025 on the WTO website.
Software Roadmap
The MHRA also continues to deliver on the existing roadmap for Software as a Medical Device. It aims to publish draft guidance on ‘Digital Mental Health Technologies’, and AI Development and Deployment by the end of March 2025.
IVD Roadmap
The MHRA’s IVD Roadmap is yet to be published. This is currently in draft form, but the MHRA are taking the opportunity to review this given the prioritisation of diagnostics in Lord Darzi’s review and the Budget. The intention is therefore for the revised roadmap to be published in Spring 2025.
EU Medical Devices Regulation
The European Parliament (EP) adopted a resolution on 23 October 2024 calling for urgent revisions to the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), specifically regarding the availability, affordability and safety of medical devices. The EP calls for transparent and binding timelines for procedural steps in conformity assessment by notified bodies including the creation of stop clocks, elimination of unnecessary re-certification of products, and fast-track and prioritisation pathways for the approval of innovative technologies.
This resolution is particularly important for those within the UK who have CE marked devices.
Implications and conclusions
As can be seen above, many steps have already been taken to implement the MHRA’s Roadmap for the future regulatory framework for medical devices since our last update in June 2024.
The awaited publication of the revised regulatory roadmap will give a better understanding of the further developments we can expect over the next couple of months, ahead of the future core regulations for medical device regulation in the UK which are intended to be laid in Parliament and in force by the end of 2025. From the information that has been released so far, it appears that the new measures will result in a regulatory framework that has greater certainty and clarity. Additionally, the focus on increasing patient safety can only be beneficial to the wider public and the robust regulations will assist with achieving this.