Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.
Please note that we are reviewing our document in light of revision 6 of the European Commission MEDDEV 2.12/1 on the medical devices vigilance system.
This document provides guidance for manufacturers and authorised representatives on:
- the aim of the EU vigilance system (also known in the UK as the ‘adverse incident reporting’ system) as specified in the directives
- the role of the vigilance system within manufacturers’ post-market surveillance systems
- the practicalities of the operation of the EU vigilance system in the UK, including how it operates alongside the existing voluntary reporting systems in the UK
- working effectively with the MHRA on adverse incidents and Field Safety Corrective Action (recalls)
This Directives Bulletin supersedes the publication 'Guidance on the Recall of Medical Devices' PDF (July 2000).
Vigilance MEDDEV rev 6 
