The Medicines and Healthcare products Regulatory Agency (MHRA) has opened an offering to provide regulatory advice meetings on medical devices and in vitro diagnostic devices for manufacturers, at a cost of £987 for one hour.
During the one hour meeting, the person or organisation requesting support is to begin with a short presentation outlining their questions and the “issues and controversies” surrounding them. The service aims to provide regulatory advice relating to medical devices, particularly if the application of existing regulatory guidance is not straightforward.
Consultancy cannot be provided for specific products, according to the MHRA, and the service also cannot provide insights into the development of future medical device regulations, long-term collaboration, or endorsement from the agency.
To request a meeting, interested parties should fill out a form in the first instance to provide details of intended users, uses, potential risks, and so on. For software and/or AI, the MHRA’s form asks questions about data inputs, computational tasks, how inputs are processed to retrieve outputs, and other functionality. The MHRA notes: “It is highly encouraged that you review all applicable published guidance before requesting a meeting. If your questions are covered in existing guidance, we will direct you to that guidance rather than offering you a meeting.”
Earlier this year, MHRA regulations entered into force requiring manufacturers to “actively monitor” the safety and performance of medical devices once on the market. The Medical Devices (Post-Market Surveillance Requirements) Regulations 2024 entered into law on 16 December 2024, taking effect from 16 June following a six-month implementation period. The regulations apply to all UKCA- and CE-marked devices placed on the GB market after 16 June 2025, including in vitro diagnostic devices, and active implantable medical devices such as pacemakers and hearing implants.
Key developments in MHRA regulation across health and care
Late last year, the Medical and Healthcare products Regulatory Agency selected five new technologies as part of the AI Airlock scheme, “to better understand how we can regulate artificial intelligence powered medical devices”. This includes medical devices for cancer, chronic respiratory disease and radiology diagnostic services.
The MHRA also published guidance in February focusing on developing safeguards, regulation and evaluation for UK digital mental health technologies including mental health apps, AI-powered assessments, and virtual reality therapy.
Earlier this year, the agency announced the launch of a digital hub in Leeds with a view to driving partnerships and innovation across the region. Set to be located in Wellington Place in Leeds city centre, the hub will initially be staffed by 30 permanent and highly-skilled roles that will sit within the Digital and Technology Group, focused on digital delivery, software development and data science.
