Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices.

Q1 Medicine GMS German Medical Science Pub Date : 2024-10-11 eCollection Date: 2024-01-01 DOI:10.3205/000335

Andy Kahles, Hannah Goldschmid, Anna-Lena Volckmar, Daniel Kazdal, Ulrich M Gassner, Michael Vogeser, Monika Brüggemann, Karl-Friedrich Bürrig, Vanessa Kääb-Sanyal, Christa Flechtenmacher, Peter Schirmacher, Albrecht Stenzinger

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Abstract

Institutes for pathology act as operators, users and in-house manufacturers of in vitro diagnostic medical devices and are subject to national and European regulations depending on their function. The entry into force of the EU regulation on medical devices (Regulation (EU) 2017/745, MDR) and the EU regulation on in vitro diagnostic medical devices (Regulation (EU) 2017/746, IVDR) resulted in a need for regulatory adjustments to German medical device law. This has created a new legal framework in which institutes for pathology operate, depending on their function as users, operators or in-house manufacturers of in vitro diagnostic medical devices. This overview of the current legal situation represents a snapshot and provides an up-to-date overview of the landscape of European and German medical device law.

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欧洲和德国医疗器械法律框架下的病理学：体外诊断医疗器械的操作、使用和内部制造。

病理机构是体外诊断医疗器械的操作者、使用者和内部制造商，并根据其职能受国家和欧洲法规的约束。欧盟医疗器械法规（Regulation (EU) 2017/745，MDR）和欧盟体外诊断医疗器械法规（Regulation (EU) 2017/746，IVDR）的生效导致德国医疗器械法需要进行法规调整。这创建了一个新的法律框架，病理机构可根据其作为体外诊断医疗器械的用户、运营商或内部制造商的职能，在此框架内开展业务。对当前法律状况的概述是对欧洲和德国医疗器械法的一个缩影和最新概述。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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