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
{"title":"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。","authors":"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","doi":"10.3205/000335","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"22 ","pages":"Doc09"},"PeriodicalIF":0.0000,"publicationDate":"2024-10-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11570832/pdf/","citationCount":"0","resultStr":"{\"title\":\"Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices.\",\"authors\":\"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\",\"doi\":\"10.3205/000335\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":39243,\"journal\":{\"name\":\"GMS German Medical Science\",\"volume\":\"22 \",\"pages\":\"Doc09\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-10-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11570832/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"GMS German Medical Science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3205/000335\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/1/1 0:00:00\",\"PubModel\":\"eCollection\",\"JCR\":\"Q1\",\"JCRName\":\"Medicine\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"GMS German Medical Science","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.3205/000335","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/1/1 0:00:00","PubModel":"eCollection","JCR":"Q1","JCRName":"Medicine","Score":null,"Total":0}
Pathology in the legal framework of European and German medical device law: Operation, use and in-house manufacture of in vitro diagnostic medical devices.
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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