Guidance

Reporting adverse incidents: neurostimulators

For manufacturers reporting adverse incidents with neurostimulators under the vigilance system.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 1 June 2013
• Last updated: 15 January 2025
  Show all updates

  1. 15 January 2025

     Updated to reflect the laying of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024.

  2. 30 December 2020

     This page has been updated due to the end of the transition period.

  3. 1 June 2013

     First published.

Documents

Device-specific vigilance guidance: neurostimulators

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Guidance for manufacturers on reporting adverse incidents involving stimulators under the vigilance system.

To be read in conjunction with the guidelines on post-market surveillance.