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
{"title":"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。","authors":"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","doi":"10.1515/cclm-2025-1033","DOIUrl":null,"url":null,"abstract":"<p><p>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.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics.\",\"authors\":\"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\",\"doi\":\"10.1515/cclm-2025-1033\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>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.</p>\",\"PeriodicalId\":10390,\"journal\":{\"name\":\"Clinical chemistry and laboratory medicine\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.7000,\"publicationDate\":\"2025-08-20\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical chemistry and laboratory medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1515/cclm-2025-1033\",\"RegionNum\":2,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICAL LABORATORY TECHNOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical chemistry and laboratory medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1515/cclm-2025-1033","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics.
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.
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!