Egbosimba David
Maetrics Ltd, Nottingham, United Kingdom (UK).
Ann Biol Clin (Paris). 2019 Oct 1;77(5):514-516. doi: 10.1684/abc.2019.1473.
In order to achieve regulatory compliance and acquire authorisation for sale in Europe, each medical device must be supported by a clinical evaluation report (CER) which documents the clinical evaluation process in its entirety. This is not a new requirement but highly publicised scandals caused by defective medical devices increased scrutiny of notified bodies (the organisations designated by the European Union to evaluate medical device compliance) meaning they are more liable and must strengthen their inspections of medical device manufacturers. Manufacturers are already under increased pressure due to the new EU Medical device regulation published in 2017. The scope of the new regulation requires many manufacturers to evaluate the documentation for their whole product portfolio. CERs are an important part of regulatory compliance and are also one of the biggest challenges for manufacturers who do not have sufficient resources and do not dedicate enough time to this task. This article examines the background of this requirement while offering medical device manufacturers advice for successful clinical evaluation reports.
为了符合监管要求并获得在欧洲销售的授权，每台医疗设备都必须有一份临床评估报告（CER）作为支撑，该报告要完整记录临床评估过程。这并非新要求，但由有缺陷的医疗设备引发的广为人知的丑闻增加了对公告机构（欧盟指定的评估医疗设备合规情况的组织）的审查，这意味着它们责任更大，必须加强对医疗设备制造商的检查。由于2017年发布的新欧盟医疗器械法规，制造商已经面临更大的压力。新法规的范围要求许多制造商评估其整个产品组合的文件。临床评估报告是监管合规的重要组成部分，对于没有足够资源且未投入足够时间完成这项任务的制造商来说，也是最大的挑战之一。本文在探讨这一要求背景的同时，为医疗设备制造商提供撰写成功临床评估报告的建议。
