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欧洲和德国医疗器械法规中的病理学：体外诊断医疗器械的操作、使用和内部制造。

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

机构信息

Institute of Pathology, Heidelberg University Hospital, Heidelberg, Germany.

Faculty of Law, Augsburg University, Augsburg, Germany.

出版信息

Ger Med Sci. 2024 Oct 11;22:Doc09. doi: 10.3205/000335. eCollection 2024.

DOI:10.3205/000335
PMID:39559338
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11570832/
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.

摘要

病理学研究所作为体外诊断医疗器械的经营者、使用者和内部制造商，根据其功能受到国家和欧洲法规的约束。欧盟医疗器械法规（(EU) 2017/745，MDR）和欧盟体外诊断医疗器械法规（(EU) 2017/746，IVDR）的生效，需要对德国医疗器械法进行监管调整。这为病理学研究所的运作创造了一个新的法律框架，具体取决于其作为体外诊断医疗器械的使用者、经营者或内部制造商的功能。本文概述了当前的法律状况，是对欧洲和德国医疗器械法领域的最新概述。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/0dec11cd4379/GMS-22-09-t-006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/07a5540f57db/GMS-22-09-t-001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/78c7489af25f/GMS-22-09-t-002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/09224b624628/GMS-22-09-t-003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/24791684c08c/GMS-22-09-t-004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/0dec11cd4379/GMS-22-09-t-006.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/07a5540f57db/GMS-22-09-t-001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/78c7489af25f/GMS-22-09-t-002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/09224b624628/GMS-22-09-t-003.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/24791684c08c/GMS-22-09-t-004.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7ce4/11570832/0dec11cd4379/GMS-22-09-t-006.jpg

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