Medicines & Healthcare Products Regulatory Agency openness over UK medical technology safety investigations:
This article was originally published in Clinica
Executive Summary
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) has begun to publish medical device manufacturers' field safety notices on its website. The initiative is intended to improve public access to the alerts and provide greater transparency on its role in overseeing corrective actions. Field safety notices are issued when a medical device needs to be recalled for technical or medical reasons, also triggering an MHRA investigation. The dedicated webpage enables the status of the investigation to be monitored.