Member

The instrument will provide greater detail for manufacturers on when and how to report serious incidents. The timelines for notifying the MHRA will be standardised throughout the UK, benefiting manufacturers that supply devices to both Northern Ireland and Great Britain and ensuring that safety issues are identified promptly, facilitating earlier interventions in order to safeguard patients. The introduction of new requirements to prepare regular reports summarising PMS data will ensure the continuous monitoring of device performance, with higher-risk devices subject to increased scrutiny.