Collection

Medical devices: guidance for manufacturers on vigilance

Information for manufacturers of medical devices about reporting adverse incidents and corrective actions to MHRA.

You must report adverse incidents with your medical device to the competent authority where the incident happened.

See the European Commission’s detailed guidance on what, how and when to report an adverse incident to MHRA.

You should also check our guidance below on what to report for certain types of devices.

Report adverse incidents via MORE or with the active PDF forms listed in section 2.12 market surveillance under Guidance MEDDEVs.

See the field safety notice (FSN) flyer to send alongside your FSN explaining what they are and why they are important to act on.

To get better response rates to your FSNs use the Medical Devices Safety Officer (MDSO) network. You can access this if you sign up to Manufacturers’ Online Reporting Environment

Further guidance on producing and distributing effective field safety notices is available

There is now a template field safety notice for you to use, available on the European Commission’s website under Guidance MEDDEVs, within section 2.12 Market surveillance. We recommend also reading the accompanying Q&A document.

Documents

Published 26 January 2015
Last updated 20 November 2018 + show all updates
  1. Further guidance on producing and distributing effective field safety notices has been added.
  2. Link to European Commissions detailed guidance updated
  3. First published.