The MHRA has published updated guidance on how manufacturers can request regulatory advice meetings for medical and IVD devices in the UK. This service helps clarify complex regulatory questions but excludes product-specific consultancy. Discover fees, scope, limitations, and how to apply.

The MHRA has released updated guidance for clinical investigations of medical devices in the UK, outlining new requirements for manufacturers, including application validation, safety reporting, UKCA/CE/CE UKNI considerations, and updated processes for studies in Great Britain and Northern Ireland. Medical device manufacturers must review these regulatory changes to maintain compliance, ensure timely clinical investigation approvals, and prepare robust technical documentation aligned with UK and EU regulatory frameworks.

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.