EC Issues Guidance on Vigilance System for Insulin-Infusion Pumps

The European Commission has released guidance for manufacturers of insulin-infusion pumps and integrated-meter systems to spell out the reporting requirements under the EU’s Medical Device Regulation.

The guidance outlines specific scenarios that should be considered when determining if an incident is reportable and it lists examples of device performance problems that should be reported.

The commission also highlights immediately reportable events and those that could be included in periodic summary reports.