Adverse incident reporting for medical devices - A comparison with pharmacovigilance

This paper reviews the European Union mandatory Vigilance Reporting System and voluntary user reporting systems for medical devices. Differences between these systems and the reporting system for pharmaceuticals are highlighted. Device vigilance is run as a single harmonized system within the European Union and increasingly there are international links. Recent trends in reporting patterns within the United Kingdom are highlighted along with initiatives to improve the number and accuracy of reports. Drug/device combination products are becoming increasingly important. The handling of adverse events for these and other new technology products are described.