• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)?

作者信息

Barberis Massimo

机构信息

Clinic Unit Histopathology and Molecular Diagnostics, European Institute of Oncology, IRCCS, Milano, Italy.

出版信息

Pathologica. 2021 Apr;113(2):68-69. doi: 10.32074/1591-951X-237. Epub 2021 Mar 18.

DOI:10.32074/1591-951X-237
PMID:33955428
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8167396/
Abstract
摘要

相似文献

1
In vitro diagnostic medical device regulation (IVDR): the end of laboratory developed tests (LDT)?体外诊断医疗器械法规（IVDR）：实验室自建检测方法（LDT）的终结？
Pathologica. 2021 Apr;113(2):68-69. doi: 10.32074/1591-951X-237. Epub 2021 Mar 18.
2
Laboratory-Developed Tests: Design of a Regulatory Strategy in Compliance with the International State-of-the-Art and the Regulation (EU) 2017/746 (EU IVDR [In Vitro Diagnostic Medical Device Regulation]).实验室自建检测方法：符合国际最新技术水平及欧盟法规（EU）2017/746（欧盟体外诊断医疗器械法规）的监管策略设计
Ther Innov Regul Sci. 2022 Jan;56(1):47-64. doi: 10.1007/s43441-021-00323-7. Epub 2021 Jul 21.
3
Implementing Regulation (EU) 2017/746 of 5 April 2017 on In vitro Diagnostic Medical Devices (IVDR) in Medical Laboratories, especially in Ophthalmopathology.2017 年 4 月 5 日关于体外诊断医疗器械（IVDR）在医学实验室中的实施条例（EU）2017/746，特别是在眼病理领域。
Klin Monbl Augenheilkd. 2022 Jul;239(7):905-912. doi: 10.1055/a-1863-9331. Epub 2022 May 30.
4
Complex analytical procedures in diagnostic laboratories and the IVDR.诊断实验室中的复杂分析程序与体外诊断医疗器械法规。
Clin Chem Lab Med. 2020 Dec 11;59(3):457-458. doi: 10.1515/cclm-2020-1775.
5
ISO 15189 is a sufficient instrument to guarantee high-quality manufacture of laboratory developed tests for in-house-use conform requirements of the European -Diagnostics Regulation.ISO 15189是确保高质量生产符合欧洲诊断法规要求的内部使用的实验室自建检测项目的充分手段。
Clin Chem Lab Med. 2023 Jan 31;61(4):608-626. doi: 10.1515/cclm-2023-0045. Print 2023 Mar 28.
6
The new IVD Regulation 2017/746: a case study at a large university hospital laboratory in Belgium demonstrates the need for clarification on the degrees of freedom laboratories have to use lab-developed tests to improve patient care.2017/746 号新体外诊断法规：比利时一家大型大学医院实验室的案例研究表明，有必要明确实验室在使用实验室自建检测以改善患者护理方面的自由度。
Clin Chem Lab Med. 2020 Jul 21;59(1):101-106. doi: 10.1515/cclm-2020-0804.
7
Implementation of the new EUR IVD regulation and relation with ISO15189 accreditation: Guidance is urgently required for haemostasis testing.实施新的欧盟体外诊断医疗器械法规与 ISO15189 认可的关系：血栓与止血检验急需指导。
Int J Lab Hematol. 2022 Sep;44 Suppl 1:71-78. doi: 10.1111/ijlh.13936.
8
Advisory opinion of the AWMF Ad hoc Commission In-vitro Diagnostic Medical Devices regarding in-vitro diagnostic medical devices manufactured and used only within health institutions established in the Union according to Regulation (EU) 2017/746 (IVDR).德国医学科学学会（AWMF）特别委员会关于仅在根据法规 (EU) 2017/746（IVDR）在欧盟境内设立的医疗机构中制造和使用的体外诊断医疗器械的咨询意见。
Ger Med Sci. 2021 Jun 1;19:Doc08. doi: 10.3205/000295. eCollection 2021.
9
[Impact of the novel in vitro diagnostic regulation (IVDR) of the European Union on pathology laboratories. What's important?].[欧盟新型体外诊断法规（IVDR）对病理实验室的影响。要点有哪些？]
Pathologe. 2020 Dec;41(Suppl 2):129-133. doi: 10.1007/s00292-020-00867-9.
10
The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications.我们所熟知的实验室自行开发检测的终结？一个由实验室专家组成的全国多学科特别工作组关于体外诊断医疗器械法规（IVDR）解读及其并发症的建议
Clin Chem Lab Med. 2020 Nov 23. doi: 10.1515/cclm-2020-1384.

引用本文的文献

1
Molecular Genetic Techniques in Biomarker Analysis Relevant for Drugs Centrally Approved in Europe.分子遗传技术在生物标志物分析中的应用与欧洲批准的中枢药物相关。
Mol Diagn Ther. 2022 Jan;26(1):89-103. doi: 10.1007/s40291-021-00567-x. Epub 2021 Dec 14.
2
Companion Diagnostics: State of the Art and New Regulations.伴随诊断：最新技术水平与新法规
Biomark Insights. 2021 Oct 11;16:11772719211047763. doi: 10.1177/11772719211047763. eCollection 2021.
3
Temporary Regulatory Deviations and the Coronavirus Disease 2019 (COVID-19) PCR Labeling Update Study Indicate What Laboratory-Developed Test Regulation by the US Food and Drug Administration (FDA) Could Look Like.临时监管调整和 2019 年冠状病毒病（COVID-19）PCR 标签更新研究表明，美国食品和药物管理局（FDA）对实验室开发的检测的监管可能是什么样子。
J Mol Diagn. 2021 Oct;23(10):1207-1217. doi: 10.1016/j.jmoldx.2021.07.011. Epub 2021 Sep 16.
4
Status Assessment for Better Care of Early Stage Non-Small Cell Lung Carcinoma: What Is Changing in the Daily Practice of Pathologists?早期非小细胞肺癌的更好护理的现状评估：病理学家的日常实践中正在发生哪些变化？
Cells. 2021 Aug 21;10(8):2157. doi: 10.3390/cells10082157.

本文引用的文献

1
The end of the laboratory developed test as we know it? Recommendations from a national multidisciplinary taskforce of laboratory specialists on the interpretation of the IVDR and its complications.我们所熟知的实验室自行开发检测的终结？一个由实验室专家组成的全国多学科特别工作组关于体外诊断医疗器械法规（IVDR）解读及其并发症的建议
Clin Chem Lab Med. 2020 Nov 23. doi: 10.1515/cclm-2020-1384.
2
The New, Stringent MDR and IVDR Regulations: Viewing this Change as an Opportunity.
Chimia (Aarau). 2018 Jun 27;72(6):430-431. doi: 10.2533/chimia.2018.430.
3
Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century!医学检验的计量溯源与协调：在21世纪，需要实现巨大飞跃才能跟上全球化步伐并符合严格的体外诊断医疗器械法规！
Clin Chem Lab Med. 2018 Sep 25;56(10):1598-1602. doi: 10.1515/cclm-2018-0343.
4
Early failure of articular surface replacement XL total hip arthroplasty.XL 人工关节表面置换全髋关节置换术后早期失败。
J Arthroplasty. 2011 Sep;26(6 Suppl):14-8. doi: 10.1016/j.arth.2011.03.027. Epub 2011 May 8.
5
Rupture of PIP breast implants.PIP 隆胸假体破裂。
J Plast Reconstr Aesthet Surg. 2007;60(8):967-8. doi: 10.1016/j.bjps.2007.01.069. Epub 2007 Apr 20.