Now that the new year is here, we discuss what businesses can expect in the changing landscape of medical devices regulation.
The revised roadmap replaces the previous version published in January 2024. Reform milestones have now been helpfully grouped into four work streams:
It is important to note that the roadmap is a living document and so we should expect some adjustment, but the current timelines are as follows:
Now that the new regulations have been signed into law, businesses have six months to get their ducks in a row before implementation. The roadmap sets out that guidance on the requirements will be published in the early part of this year - so, watch this space.
The Government is currently working on the statutory instrument for the new pre-market requirements. According to the roadmap, we can expect this to be introduced to Parliament towards the end of the year. For now, consultation processes remain ongoing and first insights into the new requirements can be expected in late Spring. Businesses should then prepare for implementation to take place in 2026.
Along with regulatory implementation, the MHRA will also be turning its head to policy development. By the middle of the year, we can expect new (or refined) guidance on the following aspects:
The MHRA is also busy developing its regulation of software as a medical device. In the early part of the year, we can expect guidance on good machine learning practice and digital mental health tech. Later in the year, the MHRA is preparing to publish guidance on AI development and deployment and cybersecurity with regards to software as a medical device. This guidance is part and parcel of regulators getting with the times and keeping up with new technologies, as discussed in my previous article.
Ultimately, the nature and scale of the UK reforms remain uncertain for the time being, but we know from the roadmap that the new pre-market requirements will be the MHRA's focus for this new year.
The statutory instrument to bring in the amended post-market surveillance regulations was made on 16 December 2024 - but there is now a 6-month implementation period to prepare before these come into force in June. During this time, manufacturers should focus on getting to grips with the new requirements.
Post-market surveillance (PMS) is a term which refers to the activities undertaken by manufacturers to collect and review information relating to devices they have made available on the market. This enables any necessary corrective or preventative actions to be identified and applied. Under the new regulations, manufacturers must have a PMS system, based on a PMS plan. There are also changes in relation to investigation, reporting and preventative and corrective action requirements.
The PMS plan must be "clear, organised and searchable", and must be maintained by manufacturers for the lifetime of the device. The regulations set out the information the plan must provide. This is extensive and includes processes relating to the collection of information on incidents and side-effects, as well as processes for investigating complaints and analysing feedback on user experience. Businesses should consult the regulations and seek early legal advice to make sure that they have compliant PMS plans in place.
The MHRA remains focused on improving patient and public safety following the findings and recommendations of the Independent Medicines and Medical Devices Safety Review. The new regulations are a key part of this aim and the MHRA will be watching to make sure businesses do not cut corners. With this in mind, businesses should take their PMS responsibilities seriously to avoid regulatory action and public criticism.
Changes are also happening in the EU. In December 2024, the Commission launched a consultation and call for evidence in relation to EU regulations 2017/745 and 2017/746 on medical devices and in vitro diagnostics. This consultation has already sparked a lot of interest, with over 120 responses at the time of writing. The responses make for an interesting read. The submissions criticise the significant compliance burden imposed by the EU regulations, citing difficulties, delays and high costs associated with certification processes. They also express frustration at requirements for low-risk devices being challenging and onerous. The consultation is scheduled to close after 21 March 2025. It will be interesting to see what changes the Commission will propose to improve certification processes and whether there will be any relaxation of the compliance burden imposed by the EU regulations.
In its blog post of 1 November 2024, the MHRA said that it will be keeping an eye on the Commission's consultation and review. The MHRA also commented on the scale of what the EU attempted and reiterated that it is taking a more stepped approach and not ruling out further changes in the future. This comparatively cautious approach brings the promise that the teething issues experienced by businesses in complying with the EU Regulations can be avoided in the UK regulatory reforms.
The updated roadmap and the MHRA's comments should reassure businesses that, although substantial regulatory change is coming, the MHRA is keen to take a slow, considered approach. Given this approach, the roadmap may be updated in response to the outcome of the EU Commission's consultation.
As with all major changes in regulation, watch the UK and EU carefully and start preparing for change early. If you need support with developing a compliant PMS plan or understanding your obligations under the new post-market surveillance regulations, please reach out to our team.