BIVDA welcomed Dr Rob Reid and Nadine Neale from the MHRA to BIVDA’s Regulatory Affairs Seminar last week. They provided updates on the latest MHRA activity including the MHRA Fees consultation, GB Post Market Surveillance, the Pre-Market SI Consultation, and the AI Airlock Pilot, which members will find useful.
We have outlined all updates below:
MHRA Fees Consultation – The public consultation on proposals to update the statutory fees closed on 24 October 2024. Subject to government process, they anticipate the response to the consultation to be published in early March 2025, followed by the implementation of changes to fees and charges, in May 2025. They remain committed to informing stakeholders upon reaching important milestones.
Post Market Surveillance – Following the publication of updated PMS requirements in GB at the end of last year, which come into force 16th June 2025, the MHRA published a raft of associated ‘draft’ guidance. MHRA are asking for user feedback by 31st March. Please forward any comment to regulatory@bivda.org.uk where Neil Plumridge will be able to collate feedback to share with the MHRA. PMS feedback will be discussed at the next UKCA Sub Group meeting 25th Feb (online).
Pre-Market SI Consultation – MHRA has received 298 responses to the consultation, they are analysing the responses and will publish the government response together with the Common Specification/CTDA consultation in April, pending ministerial agreement. The provision to remove the sunset date of 25 and 26 May 2025 for the assimilated EU laws will be addressed immediately due to the impending date. The four pieces of assimilated EU law in UK legislation will not have a sunset date.
Their legal team are continuing to draft the pre-market statutory instrument and will include the feedback from the recent consultation. As soon as they have a solid draft statutory instrument, they will share this with Trusted Advisor Groups for review and comment, before submission to the WTO.
AI Airlock Pilot – In May 2024, the MHRA announced the AI Airlock initiative. The AI Airlock serves as a regulatory sandbox for Artificial Intelligence as a Medical Device (AIaMD), aimed at enhancing our understanding and expediting solutions to the novel regulatory challenges posed by AIaMD. The Prime Minister’s assessment of the government’s action plan for AI, “We will test and understand AI before we regulate it, to ensure that when we do so, it is proportionate and grounded in the science”, will underpin the approach of the AI Airlock.
Five innovative technologies have been selected for the AI Airlock pilot scheme. The pilot is currently in progress, with ongoing testing and iterations for each of the technologies. The pilot will conclude in March 2025, with the results intended to guide future regulations and guidelines.
Digital Mental Health Technologies – Digital mental health technologies (DMHTs) encompass software products and related hardware designed to support mental health and well-being. The MHRA has recently published guidance to assist manufacturers in defining the characteristics of their devices and determining the appropriate regulatory qualifications and classifications. The MHRA and NICE have developed this guidance to explain the regulation and evaluation of DMHTs, ensuring that only safe and effective products are accessible to patients and the public. Some DMHTs qualify as SaMD and must comply with the relevant medical device regulations. The guidance provides clarity on how to ascertain this and how UKCA/CE certification demonstrates compliance with these regulations.
Head of Software and AI medical devices – Dr. Marinos Ioannides has joined the Innovative Devices team as Head of Software and AI Medical Devices. Marinos comes to the MHRA from the Cabinet Office, where he successfully delivered complex technical programmes as Head of Data Science. He brings extensive experience in software development and the application of AI technologies, which are integral to the MHRA’s ongoing efforts in regulating software medical devices and advancing such innovations. Marinos holds two bachelor’s degrees in medicine and biomedical sciences (majoring in cardiology).
Medical Devices Regulatory Reform roadmap – Published in December 2024, you can find the roadmap here.
