Department of Pharmaceutical Biosciences, Uppsala University, Uppsala, Sweden.
JMIR Mhealth Uhealth. 2020 Jun 26;8(6):e17567. doi: 10.2196/17567.
The Poly Implant Prothèse (PIP) scandal in France prompted a revision of the regulations regarding the marketing of medical devices. The new Medical Device Regulation (MDR [EU]) 2017/745 was developed and entered into force on May 25, 2017. After a transition period of 3 years, the regulations must be implemented in all EU and European Economic Area member states. The implementation of this regulation bears many changes for medical device development and marketing, including medical device software and mobile apps. Medical device development and marketing is a complex process by which manufacturers must keep many regulatory requirements and obligations in mind. The objective of this paper is to provide an introduction and overview of regulatory affairs for manufacturers that are new to the field of medical device software and apps with a specific focus on the new MDR, accompanying harmonized standards, and guidance documents from the European Commission. This work provides a concise overview of the qualification and classification of medical device software and apps, conformity assessment routes, technical documentation, clinical evaluation, the involvement of notified bodies, and the unique device identifier. Compared to the previous Medical Device Directive (MDD) 93/42/EEC, the MDR provides greater detail about the requirements for software qualification and classification. In particular, rule 11 sets specific rules for the classification of medical device software and will be described in this paper. In comparison to the previous MDD, the MDR is more stringent, especially regarding the classification of health apps and software. The implementation of the MDR in May 2020 and its interpretation by the authorities will demonstrate how app and software manufacturers as well as patients will be affected by the regulation.
法国的 Poly Implant Prothèse (PIP) 丑闻促使人们修订了有关医疗器械营销的法规。新的医疗器械法规 (MDR [EU]) 2017/745 于 2017 年 5 月 25 日制定并生效。经过 3 年的过渡期，该法规必须在所有欧盟和欧洲经济区成员国实施。该法规的实施给医疗器械的开发和营销带来了许多变化，包括医疗器械软件和移动应用程序。医疗器械的开发和营销是一个复杂的过程，制造商必须牢记许多监管要求和义务。本文的目的是为医疗器械软件和应用程序领域的制造商提供一个关于监管事务的介绍和概述，特别关注新的 MDR、配套协调标准和欧盟委员会的指导文件。本文提供了医疗器械软件和应用程序的资格和分类、合格评定途径、技术文件、临床评估、通知机构的参与以及独特器械标识的简明概述。与之前的医疗器械指令 (MDD) 93/42/EEC 相比，MDR 对软件的资格和分类要求提供了更详细的信息。特别是，规则 11 为医疗器械软件的分类制定了具体规则，本文将对此进行描述。与之前的 MDD 相比，MDR 更加严格，特别是在健康应用程序和软件的分类方面。MDR 于 2020 年 5 月的实施及其在当局的解释将展示法规将如何影响应用程序和软件制造商以及患者。
