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紧急呼吁欧盟委员会简化和将IVDR第5.5条置于特定和精确诊断的背景下

Christa Cobbaert1, Christian Schweiger2, Christoph Buchta3

  • 1Department of Clinical Chemistry and Laboratory Medicine, 4501 Leiden University Medical Center , Leiden, The Netherlands.

Clinical chemistry and laboratory medicine
|August 19, 2025
PubMed
概括

欧盟体外诊断法规 (IVDR) 面临着挑战. 建议修改第5.5条,以简化内部IVD (IH-IVD),确保患者安全和获得罕见疾病测试.

关键词:
欧洲委员会 欧洲委员会 欧洲委员会在IH-IVDs.第四十五条第五五条第五五五条不成比例的监管.精准诊断 精准诊断 精准诊断 精准诊断 精准诊断

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