MHRA neurostimulator guidance
This article was originally published in The Gray Sheet
Executive Summary
U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) is accepting comments through Sept. 30 on its 1draft guidance on adverse events involving neurostimulators, released on its Web site July 31. The draft states that manufacturers of neurostimulators should notify MHRA if problems related to their device result in a clinically relevant increase in the duration of a surgical procedure, as defined by the operating surgeon, if the cause for the neurostimulator incident is not well defined and the manufacturer is unable to obtain further information in the reporting timescale, and if the device has been subject to a field safety corrective action. The guidance also provides a list of reportable adverse events specific to neurostimulators, and defines cases where periodic summary reporting and adverse incident trending are appropriate