Michael Vogeser, Monika Brüggemann, Kristina Brandt, Uta Ceglarek, Volker Gieskes, Niclas Hitziger, Andy Kahles, Ernst Klar, Dirk Roggenbuck, Henning Schliephake, Ortwin Schulte, Sascha Wettmarshausen, Uwe Zimmermann, Ulrich Sack, Albrecht Stenzinger
{"title":"欧盟体外诊断医疗器械 (IVDR) 法规在实践中的实施与应用--德国科学医学协会 (AWMF) 于 2023 年 3 月组织的一次公开活动的成果。","authors":"Michael Vogeser, Monika Brüggemann, Kristina Brandt, Uta Ceglarek, Volker Gieskes, Niclas Hitziger, Andy Kahles, Ernst Klar, Dirk Roggenbuck, Henning Schliephake, Ortwin Schulte, Sascha Wettmarshausen, Uwe Zimmermann, Ulrich Sack, Albrecht Stenzinger","doi":"10.3205/000327","DOIUrl":null,"url":null,"abstract":"<p><p>In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became clear that the implementation of the IVDR still poses significant challenges for laboratory medicine and pathology. Corrections at the political level and implementation with a sense of proportion are required. Before the long-term goal of the IVDR, i.e. the increase in patient safety, can be realized, the prevention of disadvantages for patients due to gaps in care must be strived for in the medium term by all parties involved.</p>","PeriodicalId":39243,"journal":{"name":"GMS German Medical Science","volume":"22 ","pages":"Doc01"},"PeriodicalIF":0.0000,"publicationDate":"2024-01-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10952015/pdf/","citationCount":"0","resultStr":"{\"title\":\"Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und Anwendung - Ergebnisse einer öffentlichen Veranstaltung der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) im März 2023.\",\"authors\":\"Michael Vogeser, Monika Brüggemann, Kristina Brandt, Uta Ceglarek, Volker Gieskes, Niclas Hitziger, Andy Kahles, Ernst Klar, Dirk Roggenbuck, Henning Schliephake, Ortwin Schulte, Sascha Wettmarshausen, Uwe Zimmermann, Ulrich Sack, Albrecht Stenzinger\",\"doi\":\"10.3205/000327\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became clear that the implementation of the IVDR still poses significant challenges for laboratory medicine and pathology. Corrections at the political level and implementation with a sense of proportion are required. Before the long-term goal of the IVDR, i.e. the increase in patient safety, can be realized, the prevention of disadvantages for patients due to gaps in care must be strived for in the medium term by all parties involved.</p>\",\"PeriodicalId\":39243,\"journal\":{\"name\":\"GMS German Medical Science\",\"volume\":\"22 \",\"pages\":\"Doc01\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2024-01-29\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10952015/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"GMS German Medical Science\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.3205/000327\",\"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/10.3205/000327","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}
Die EU-Verordnung für In-vitro-Diagnostika (IVDR) in der Praxis: Umsetzung und Anwendung - Ergebnisse einer öffentlichen Veranstaltung der Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften (AWMF) im März 2023.
In order to discuss first experiences with the implementation of the EU Regulation on In Vitro Diagnostic Medical Devices (IVDR) about one year after its entry into force, the German Association of the Scientific Medical Societies (AWMF e.V.) organized a full-day public webinar. Overall, it became clear that the implementation of the IVDR still poses significant challenges for laboratory medicine and pathology. Corrections at the political level and implementation with a sense of proportion are required. Before the long-term goal of the IVDR, i.e. the increase in patient safety, can be realized, the prevention of disadvantages for patients due to gaps in care must be strived for in the medium term by all parties involved.