Effective field safety notices (FSNs): guidance for manufacturers of medical devices

The medical devices regulations require manufacturers to inform users about corrective actions involving their device as soon as possible using a Field Safety Notice (FSN). Manufacturers must keep records to help trace distributed products and provide supplementary information to the MEDDEV guidelines. FSNs should be written in a clear style, avoiding jargon or technical language, and include crucial instructions for recipients. The MHRA reviews and monitors FSNS, with specialists conducting initial reviews and management meetings reviewing them selectively. Field corrective actions may arise from minor device-related safety issues, but are not considered FSCAs unless they pose a risk of death or serious injury.