UK's MHRA issues draft guidance on neurostimulators

The UK's Medicines and Healthcare products Regulatory Agency has issued draft guidance for manufacturers of neurostimulators, giving advice on reporting of adverse incidents involving their products under the Medical Devices Vigilance System.

The guidance is intended to facilitate the uniform application and implementation of the European Medical Devices Directive (93/42/EEC) and is supplementary to the European Commission guidelines on the medical devices vigilance system and associated MHRA guidance.

The medical device directives, the MHRA explains, require neurostimulator manufacturers to notify the national competent authority about reports of any deterioration or malfunctioning involving their products and about field safety corrective actions.

The guidance provides a non-exhaustive list of some incidents that would be reportable under the vigilance system. These include: telemetry failure (during or after implantation); fracture of accessory/introducer items; premature battery depletion; inability of rechargeable battery to hold charge; mechanical failure of pulse generator (including internal components); electrical failure of pulse generator; unexplained loss of therapy; neuropraxia; and tissue damage.

Stakeholders have until September 30 to submit feedback on the agency's proposals.