A UK medical devices regulator's perspective on registries.
Registries are powerful tools to support manufacturers in the fulfilment of their obligations to perform post-market surveillance and post-market clinical follow-up of implantable medical devices. They are also a valuable resource for regulators in support of regulatory action as well as in providing information around the safety of new and innovative technologies. Registries can provide valuable information on the relative performance of both generic types and manufacturer's individual products and they complement other sources of information about device performance such as post-market clinical studies and adverse incident reporting. This paper describes the experience of the UK medical device regulator - the Medicines and Healthcare Products Regulatory Agency (MHRA) - of working with registries to monitor the safety and performance of medical devices. Based upon this experience, the authors identify a number of attributes for a registry which they consider to be key if the registry is to contribute effectively to the work of regulators on patient safety monitoring and medical device regulation.
John
J
Wilkinson
Andy
A
Crosbie
D006801:Humans; D019736:Prostheses and Implants / Q000009:adverse effects* / Q000592:standards; D062486:Public Health Surveillance; D011785:Quality Assurance, Health Care; D012042:Registries; D012308:Risk Management; D012449:Safety; D006113:United Kingdom