Vigilance

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 (updated February 2008).

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 in the UK. It will also explain 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 be included.

The above bulletin endorses the use of MEDDEV 2.12-1 Rev 5 of the 'Guidelines on a Medical Devices Vigilance System' which was published on the European Commission website in July 2007. The updated MEDDEV is the culmination of a major revision exercise. The European Commission states that these revised guidelines came into force on 1 January 2008.

The MHRA has produced a short article highlighting some of the major changes.
› MEDDEV guidance Rev 5 review