Jefferys D B
Medical Devices Agency, Hannibal House, Elephant and Castle, London SE1 6TQ.
Br J Clin Pharmacol. 2001 Sep;52(3):229-35. doi: 10.1046/j.0306-5251.2001.01416.x.
This article reviews the regulation of medical devices in the UK and Europe and compares the regulatory regime with that for pharmaceuticals. The regulation of devices follows the 'New Approach' policy of the EC Commission and involves more self-regulation and conformity assessment. The controls are relatively recent beginning in 1993 for Active Implantable Devices and concluding with the In Vitro Diagnostic Directive implemented in June 2000. The article describes how the directives have been implemented in the UK, the role of the Notified Bodies and the role of the Medical Device Agency (MDA) as the competent authority. In particular the Agency's compliance and standards work is described along with the strategy and post marketing surveillance and adverse incident scheme. The MDA is a key international device regulatory agency and its international role is discussed. So too is its device evaluation programme for the NHS and how this complements the work of NICE. The article also considers the future direction of the MDA and changes in the device sector.
本文回顾了英国和欧洲对医疗器械的监管情况，并将监管制度与药品监管制度进行了比较。器械监管遵循欧盟委员会的“新方法”政策，涉及更多的自我监管和合格评定。这些管控措施相对较新，始于1993年对有源植入性器械的管控，止于2000年6月实施的体外诊断指令。本文描述了这些指令在英国是如何实施的，公告机构的作用以及作为主管当局的医疗器械局（MDA）的作用。特别介绍了该机构的合规和标准工作，以及其战略、上市后监督和不良事件计划。MDA是一个关键的国际器械监管机构，并讨论了其国际作用。还讨论了其针对国民健康服务体系（NHS）的器械评估计划以及该计划如何补充国家卫生与临床优化研究所（NICE）的工作。本文还考虑了MDA的未来方向以及器械领域的变化。
