Directives Bulletin 3 - Guidance on the operation of the EU vigilance system in the UK

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).