Adverse incident reporting for medical devices – A comparison with pharmacovigilance

Article type: Research Article

Authors: Jefferys, David

Affiliations: Senior Regulatory Strategic Adviser, Eisai Europe, 3 Shortlands, London W6 8EE, UK Tel. +44 1451 822 238, E-mail: [email protected]

Note: [] The opinions expressed are personal views and do not represent the views of the author's present or previous employers. Dr. Jefferys was formerly Chief Executive and Director of the UK Medical Devices Agency.

Abstract: 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.

Keywords: Medical devices, pharmacovigilance, vigilance, user error, drug/device combinations

Journal: International Journal of Risk and Safety in Medicine, vol. 18, no. 1, pp. 9-17, 2006