UK Updates Its Guidance on EU Vigilance System

To bring the UK’s guidelines in line with last year’s changes to the EU’s vigilance guidance system, the Medicines and Healthcare Regulatory products Agency (MHRA) updated its guidance on adverse incident reporting. The UK guidance provides information on the aim of the EU vigilance system, the role of vigilance systems within devicemakers’ postmarket surveillance systems, practical aspects of operating the EU system in the UK and cooperating with the MHRA on adverse events and product recalls.