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 new version of the MIR 7.3.1 form, published by the European Commission, brings relevant changes for manufacturers of medical and in vitro diagnostic devices. The updated form is mandatory in the context of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), and is aligned with post-market surveillance (PMS) requirements and the future use of the EUDAMED system. Manufacturers must ensure that they use the new MIR model, with updated fields, IMDRF coding, EMDN nomenclature and structured data such as UDI-DI, Basic UDI and SRN.