UK MHRA issues Roadmap towards new medical devices rules

Back in September 2021, the UK MHRA launched a Consultation to overhaul the UK’s medical device regulatory regime - see our previous analysis here. While the Government’s detailed response to the Consultation was released in June 2022 (see our analysis here), no concrete changes have yet materialised. 

In January, the MHRA published a detailed Roadmap (with timelines) towards the future regulatory framework for medical devices, together with updated guidance on the implementation of future regulations.

No indication of substantive changes to the 2022 regulatory proposals 

The first headline point is that there is no indication of any significant departures in substance from the Government’s detailed 2022 position. 

However, no draft regulations accompany the publications and the “Core Regulations”, which will cover the main substantive changes (e.g. to classification of certain types of device; clarification of the requirements for economic operators; and determining applicable cybersecurity requirements for software as a medical device) are to be subject to further stakeholder discussions during 2024. 

Closer alignment to the EU regulatory regime

Where there is a perceptible shift, however, is with respect to potential closer anticipated alignment with the EU. 

In September 2021, we noted the attitude of the then-Secretary of State for Health and Social Care, Sajid Javid, who, when announcing the consultation, stressed the “newfound regulatory freedom and a unique chance to reshape our rules”, post-Brexit. Although the Government indicated in 2022 that it intended to align with international best practice in certain respects, it was clear that it also intended to go beyond the EU MDR and other international requirements in some areas. 

Now, however, the focus in the updated guidance is on regulations that will “bring the essential requirements for medical devices being placed on the market in [the UK] into greater alignment with those of the EU.” The Timeline, for example, specifically calls out future stakeholder discussions on core regulations as to international recognition. 

This perhaps reflects a more general shift in the last year or so in the MHRA’s attitude towards the regulation of medical devices in the EU, exemplified by the UK’s recent extended acceptance of CE marked medical devices.

The ABHI (Association of British HealthTech Industries) called out the international recognition and collaboration aspects of the recent publications, in particular, as an important step toward ensuring that UK patients maintain access to safe and effective HealthTech.

Timeline for implementation

Another aspect that is clear is that the timeline appears much more protracted than originally anticipated. 

In 2021, although a “stepwise” and “phased” approach was foreseen, with transitional provisions, it was expected that amendments to the scope of the UK medical device regulations would be in place by July 2023 “to align with the date from which the UK will stop accepting CE marked medical devices and will begin requiring UKCA marking.” Of course, the Government has since changed tack with respect to planned enforcement of UKCA marking with the significant extension of the acceptance of CE marked medical devices up to June 2030. 

The 2024 Roadmap envisages the introduction of some preliminary regulatory measures in the first half of 2024, including for new post-market surveillance regulations and for IVDR regulations to be in place in Northern Ireland. However, the IVD Roadmap is not anticipated until later this year, and for the Core Regulations for medical devices, these are not anticipated to be laid before the UK Parliament until some (unspecified) time in 2025. 

Comment:

• Industry groups have been broadly supportive of the development, including the ABHI and BIVDA (British In Vitro Diagnostics Association). 
• We still need to see the concrete proposals to assess their likely impact, including, for example clarification of the obligations to be placed on economic operators. It seems we will have to wait a while longer for these. 
• Now is a critical time for industry and interested stakeholders to participate in discussions to shape and influence how these proposals will come to life in draft legislation and further guidance.