The AI Airlock initiative, launched by the MHRA, is an innovative regulatory sandbox designed to support the development and evaluation of Artificial Intelligence medical devices (AIaMD). This controlled regulatory environment allows manufacturers of AI-based medical technology to test compliance approaches, clinical evidence and algorithmic validation prior to formal submission. With a focus on adaptive machine learning models, algorithmic security and continuous monitoring, AI Airlock represents a strategic opportunity to accelerate market access with UKCA compliance.

The MHRA has published a new Periodic Safety Update Report (PSUR) template for medical devices in the UK, in line with the UK MDR. The document details how manufacturers should structure their post-market monitoring (PMS) reports, including performance data, surveillance, PMCF and benefit-risk profile analysis.

The MHRA has published a new version of the guide to classifying borderline products with medical devices. This update clarifies the criteria used in the UK to determine whether or not a product is a medical device, with a direct impact on cosmetic products, food supplements and others with therapeutic claims. If you operate in this market, it is essential to review the declared purposes, clinical evidence and regulatory framework.

The MHRA has released an update on the registration of medical devices in the UK, specifying the requirements for domestic and international manufacturers. The MHRA reinforces the need for compliance with the new surveillance and registration requirements, ensuring that medical devices and IVDs meet UK regulatory requirements before they are placed on the market.

The MHRA has confirmed that four key EU regulations for the regulation of medical devices and in vitro diagnostic medical devices (IVDs) will be retained in the UK after May 26, 2025. The decision covers rules on common technical specifications, electronic instructions for medical devices, the use of tissues of animal origin and the supervision of approved bodies. In addition, the MHRA plans to update the legislation, replacing the reference to Regulation (EU) 207/2012 with the more recent Implementing Regulation (EU) 2021/2226. Meanwhile, further changes are expected with the upcoming "Pre-Market" legislation, which could impact the requirements for high-risk IVDs and remove temporary approvals for COVID-19 testing. Manufacturers and companies in the sector should follow these updates to ensure regulatory compliance in the UK market.