UK – September 2026: Medical device safety reporting is an important part of post-market surveillance and regulatory compliance for companies placing medical devices on the UK market. Manufacturers need effective processes to identify, assess, investigate and report relevant incidents while taking appropriate action when safety risks are identified.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating medical devices in the UK. Under the current Great Britain vigilance requirements, manufacturers must report serious incidents involving their devices when the applicable reporting criteria are met. The MHRA also requires reporting of relevant field safety corrective actions (FSCAs) and adverse trends.

The reporting process involves more than submitting an incident notification. Manufacturers are responsible for investigating incidents, assessing potential causes, reviewing similar events and determining whether corrective action is necessary. Where appropriate, a field safety corrective action can help reduce or prevent further safety risks associated with devices already placed on the market.

Current MHRA guidance states that serious incidents should be reported through the Manufacturer’s Online Reporting Environment (MORE). The maximum reporting period depends on the type of serious incident: serious public health threats must be reported within two calendar days, deaths or unanticipated serious deterioration in health within 10 calendar days, and other serious incidents within 15 calendar days.

Medical device safety reporting can cover a wide range of situations, including device failures, performance problems, labelling issues and incidents that could result in serious harm. Manufacturers should assess individual events against the applicable regulatory criteria rather than assuming that every complaint automatically requires a regulatory report.

Effective vigilance systems can therefore support manufacturers in maintaining regulatory documentation, monitoring post-market safety information and responding appropriately when potential risks emerge. Companies operating in the UK can benefit from structured procedures covering complaint handling, incident assessment, investigation, reporting, trend monitoring and corrective actions.

Company Acorn Regulatory

Acorn Regulatory provides regulatory support for pharmaceutical and medical device companies, including regulatory affairs, medical device regulatory consulting, regulatory compliance and vigilance-related activities. The company supports businesses seeking structured approaches to UK and Ireland regulatory requirements and medical device post-market activities.