Euro Roundup: MHRA commission makes recommendations on AI regulatory framework in the UK
A commission set up by the Medicines and Healthcare products Regulatory Agency (MHRA) has shared 44 recommendations about the future regulatory framework for AI in the UK.
MHRA created the National Commission into the Regulation of AI in Healthcare in September to support the safe, fast, and trusted regulation, development, and use of the emerging technology. After running a research and engagement program, the commission has identified a need to move away from a system that relies heavily on one-off pre-market assessments and toward a lifecycle-based approach.
“A more tailored, flexible, and proportionate approach to regulation is required,” the commission said. “This can not only enhance safety but can foster an ecosystem that enables innovation through ensuring that the regulatory requirements are proportionate, and that they do not impose unnecessary regulatory burden that could hinder patient access to beneficial devices.”
The approach is intended to enable MHRA to focus its time and resources on devices that benefit from closer scrutiny and oversight. Levels of regulation for device types may need to be reviewed and updated over time, the commission said, to adapt oversight to evolving understanding of safety, performance, and ongoing controls.
MHRA should systematically review and update the existing UK Medical Devices Regulations to allow for a more tailored approach to software and AI-enabled medical devices, the commission said. Specific tasks included updating the definition of a medical device, for example to explicitly clarify exemptions for software used in healthcare administration, for wellbeing purposes, or for decision support.
In parallel, the commission wants MHRA to improve regulatory guidance. The new guidance should look at the application of the risk-based classification system to relevant software and AI-enabled devices and clarify how “intended purpose” is interpreted for such products.
The rise of software with a mix of features that meet the medical device definition and capabilities that are exempt informed the commission’s call for function-based regulation. Rather than review all aspects of, for example, an ambient voice technology that summarizes and transcribes speech, MHRA would only consider capabilities that may be classed as a medical device.
Other proposals include the introduction of staged-authorization pathways. Under that model, initial safety data and agreed risk controls and reporting would support use of an AI-enabled medical device in a tightly controlled scope. MHRA would expand its authorization as the device met prespecified evidence thresholds for performance and safety.
The commission believes MHRA needs enhanced enforcement mechanisms to regulate the technology. The enhanced mechanisms could include financial penalties for manufacturers that fail to comply with legal requirements and place patients at risk.
Having received the recommendations, the government will consider and act on the advice. MHRA envisions a continued collaboration between all affected stakeholders to build on the recommendations.
Commission Recommendations, Press Release
Drug and device groups welcome EU procurement proposals, push for changes
EFPIA and MedTech Europe have welcomed the proposed Public Procurement Act’s focus on moving away from price-only decisions about drug and device purchases.
Last week, the European Commission proposed the regulation to modernize and simplify the EU's public procurement framework. The act will make Best Price-Quality Ratio (BPQR) the standard award method, with quality criteria accounting for at least 30%. However, the proposal allows contracting authorities to deviate from the approach if they explain how quality will otherwise be ensured.
Pharma trade group EFPIA voiced support for the move to BPQR, calling it “an important shift away from procurement decisions driven primarily by the lowest price.” MedTech Europe, which represents medical device manufacturers, said “ending lowest-price buying is the single most important improvement.” Medicines for Europe, a trade group for off-patent drugmakers, also backed ending price-only tenders.
However, resilience and security proposals and an option for public buyers to apply European preference requirements raised concerns. The European preference requirements would allow public buyers to restrict participation, require minimum EU or covered origin, or grant evaluation preferences.
MedTech Europe called for the EU to reconsider the European preference proposal. “Origin rules focused on the place of final assembly risk overlooking the research, design, certification, and clinical support delivered in Europe, and requirements reaching down to individual components could delay patient access to the best available technology,” the trade group said.
EFPIA cautioned that “rigid geographical preferences or numerical localization thresholds risk restricting competition and weakening, rather than strengthening, security of supply.” Authorities must ensure that resilience and sustainability criteria are “proportionate, evidence-based, and non-discriminatory and do not become direct or indirect localization requirements,” EFPIA added.
The European Parliament and the Council of the European Union will now conduct negotiations based on the Commission’s proposal. The Parliament is aiming to conclude negotiations in the fourth quarter of 2027.
EFPIA Notice, MedTech Europe, More
EMA seeks feedback on updated guidance on migraine and cluster headache trials
The European Medicines Agency (EMA) has shared a draft guideline on migraine and cluster headache trials for consultation.
EMA adopted a guideline on migraine trials in 2004 and updated the document in 2007. The new draft revision provides clinical development recommendations for drugs to treat acute migraine attacks and to prevent episodic and chronic migraine.
The proposals reflect recent changes to recommendations for the clinical development of episodic and chronic migraine drugs, including new advice on trial design, patient selection, endpoints, and the use of active comparators. EMA has commented on the distinction between episodic and chronic migraine and changed its recommended primary endpoint for prophylactic migraine studies.
EMA has also proposed recommendations for acute and prophylactic treatment of episodic and chronic cluster headache. The cluster headache section covers study designs, patient populations, and primary and secondary endpoints.
The draft is open for comment until 31 January. EMA sought feedback on a migraine concept paper in 2016, at which time it planned to share a draft revision to the 2007 guideline in 2017.
MHRA shares guidance on electronic health records to support UK clinical trials
MHRA has published guidance on electronic health records (EHRs) to help clinical trial sites comply with UK regulations.
Responding to stakeholder queries, MHRA has provided points to consider when designing, building, and implementing EHR systems. The guidance is intended to provide clarity for commercial organizations sponsoring clinical trials within the UK healthcare service, as well as for study sites. Commercial sponsors may reject hospitals with non-compliant EHR systems during the site selection process, MHRA said.
“Ensuring robust, compliant electronic systems from the outset will enable the NHS to continue to be involved in hosting the highest standards of research in the UK,” MHRA said. “It is recommended that this is achieved by having an R&D representative on EHR project boards.”
The guidance lists EHR compliance issues, such as the inability to demonstrate investigator oversight and a lack of audit trails for tracking changes made to trial data. MHRA also provided guidance and factors to consider. The section covers details such as the need to establish quality control processes for editing images, for example to remove subject identifiers, before sharing the materials with sponsors.
Other News:
MHRA has updated its guidance on pre-submission requirements for innovative medicines applications. The update covered notification expectations, circumstances where MHRA may require pre-submission meetings, and information-sharing arrangements for the agency’s aligned pathway with the National Institute for Health and Care Excellence. MHRA Guidance