Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics.

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Christa Cobbaert, Christian Schweiger, Christoph Buchta, Thomas Streichert, Florent Vanstapel, Francois Mullier, Lucas Biaggini, Ettore Capoluongo, Patrick Bossuyt, Harjit Pal Bhattoa, Tom Melvin, Michael Neumaier
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Abstract

The European Commission (EC) started targeted evaluations and public consultations regarding the EU IVDR 2017/746 to assess its effectiveness, efficiency, relevance, and EU-added value. The goal is to identify implementation challenges and unintended consequences, experienced by either IVD-manufacturers that put CE-IVDs on the EU market or by medical laboratories that establish and operate in-house-IVDs (IH-IVDs) in their healthcare institution (network). Based on stakeholder feedback the EC aims to be informed about potential regulatory revisions by late 2025. As IH-IVDs, used in different modes, have a vital role in the EU healthcare system, the authors make the statement that Article 5.5 of the IVDR should be systemically amended, removing conditions (a) and (d) through (i) for in-house tests, while retaining conditions (b) and (c). Having the prime objectives of the IVDR in mind, i.e. patient safety and clinical utility, this opinion paper urges the EC to revise IVDR Article 5.5 to prevent disservices to patients and caregivers by taking into account available quality management infrastructure in ISO 15189:2022 accredited medical laboratories and guaranteed professionality of registered laboratory specialists, both already monitored at the level of the EU member states. By abandoning unnecessary, non-valuable requirements from Article 5.5 overregulation is prevented and the sustainability of important specialty and orphan tests, essential for patients with rare diseases, is guaranteed.

紧急呼吁欧盟委员会简化IVDR第5.5条并将其背景化,以进行量身定制的精确诊断。
欧盟委员会(EC)开始对欧盟IVDR 2017/746进行有针对性的评估和公众咨询,以评估其有效性、效率、相关性和欧盟附加值。目标是确定将ce - ivd投放欧盟市场的ivd制造商或在其医疗机构(网络)中建立和操作内部ivd (ih - ivd)的医学实验室所经历的实施挑战和意外后果。根据利益相关者的反馈,欧盟委员会的目标是在2025年底之前了解潜在的监管修订。由于以不同模式使用的ih - ivd在欧盟医疗保健系统中发挥着至关重要的作用,作者声明,IVDR第5.5条应该进行系统修改,删除内部测试的条件(a)和(d)至(i),同时保留条件(b)和(c)。考虑到IVDR的主要目标,即患者安全和临床效用,本意见文件敦促欧盟委员会修改IVDR第5.5条,通过考虑ISO 15189:2022认可的医学实验室的可用质量管理基础设施和注册实验室专家的保证专业性,防止对患者和护理人员造成伤害,这两者都已经在欧盟成员国层面进行了监控。通过放弃第5.5条中不必要的、无价值的要求,可以防止过度监管,并保证对罕见疾病患者至关重要的重要专业和孤儿检测的可持续性。
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来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
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