Instytut Mikromechaniki i Fotoniki, Politechnika Warszawska, Warszawa, Polska.
Ortop Traumatol Rehabil. 2021 Oct 31;23(5):381-387. doi: 10.5604/01.3001.0015.4360.
This article has the form of a communication presenting recent legal changes in relation to medical devices. Until 26 May 2021, three medical directives were in force, namely Directive 98/79 / EC, Council Directive 93/42/ EEC and Council Directive 90/385 / EEC. They have been replaced by two regulations: Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices. The article presents the reasons for introducing the changes and the new obligations that these changes bring for manufacturers of medical devices, in particular, products manufactured individually on a special order as necessary for the implementation of personalized therapies in clinical practice. There are also forecasts for the industry and end users of medical devices manufactured to order and used individually at medical centers.
这是一篇通讯形式的文章，介绍了医疗器械领域的最新法律变化。截至 2021 年 5 月 26 日，共有三项医疗指令生效，即指令 98/79 / EC、理事会指令 93/42 / EEC 和理事会指令 90/385 / EEC。它们已被两项法规取代：医疗器械法规 (EU) 2017/745 和体外诊断医疗器械法规 (EU) 2017/746。本文介绍了引入这些变化的原因，以及这些变化为医疗器械制造商带来的新义务，特别是为了在临床实践中实施个性化治疗而按特殊订单制造的个别医疗器械产品。对于按照订单制造并在医疗中心个别使用的医疗器械的行业和最终用户也进行了预测。
