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.