Obligations on manufacturers for reporting adverse incidents and field safety corrective actions to the MHRA.
General information on the vigilance system can be found in Bulletin No 3 - Guidance on the operation of the EU vigilance system in the UK. This guidance clarifies the role played by the manufacturer or their authorised representative and by the MHRA in ensuring efficient and effective adverse incident investigation and field safety corrective action (FSCA) in the UK. It also explains how these systems operate in practice alongside the existing voluntary reporting systems in the UK.
It replaces previous MHRA vigilance and recall guidance and provides advice on the nature and timing of information which should be submitted by the manufacturer or their authorised representative to the MHRA for assessment. Details of the nature of the MHRA’s assessments and of EU and MHRA expectations for information to be provided during the course of the investigation or FSCA are also included.
Our guidance endorses the use of MEDDEV 2.12/1 Market surveillance, medical devices vigilance system' (external link), published on the European Commission website. The latest version, revision 6, was published in December 2009.
