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。

Q1 Medicine
GMS German Medical Science Pub Date : 2024-01-29 eCollection Date: 2024-01-01 DOI:10.3205/000327
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
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引用次数: 0

摘要

为了讨论欧盟体外诊断医疗设备法规(IVDR)生效约一年后的初步实施经验,德国科学医学协会(AWMF e.V.)组织了一次全天公开网络研讨会。总体而言,IVDR 的实施显然仍对实验室医学和病理学构成重大挑战。需要在政治层面上进行纠正,并以适度的方式实施。在实现 IVDR 的长期目标(即提高患者安全)之前,有关各方必须在中期内努力防止因护理差距而对患者造成的不利影响。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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.

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来源期刊
GMS German Medical Science
GMS German Medical Science Medicine-Medicine (all)
CiteScore
6.30
自引率
0.00%
发文量
10
审稿时长
11 weeks
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