Complex analytical procedures in diagnostic laboratories and the IVDR

doi:10.1515/cclm-2020-1775

Editorial

. 2020 Dec 11;59(3):457-458.

doi: 10.1515/cclm-2020-1775.

Complex analytical procedures in diagnostic laboratories and the IVDR

Michael Vogeser¹, Monika Brüggemann²

Affiliations

¹ Institute of Laboratory Medicine, University Hospital, LMU Munich, Munich, Germany.
² Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany.

PMID: 33554564
DOI: 10.1515/cclm-2020-1775

Free article

Editorial

Complex analytical procedures in diagnostic laboratories and the IVDR

Michael Vogeser et al. Clin Chem Lab Med. 2020.

Free article

. 2020 Dec 11;59(3):457-458.

doi: 10.1515/cclm-2020-1775.

Authors

Michael Vogeser¹, Monika Brüggemann²

Affiliations

¹ Institute of Laboratory Medicine, University Hospital, LMU Munich, Munich, Germany.
² Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany.

PMID: 33554564
DOI: 10.1515/cclm-2020-1775

No abstract available

Keywords: Regulation (EU) 2017/746; in vitro diagnostic medical device regulation (IVDR); laboratory-developed tests (LDT).

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References

1. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj.
1. Vermeersch, P, Van Aelst, T, Dequeker, EMC. The new IVD Regulation 2017/746: a case study at a large university hospital in Belgium demonstrates the need for clarification on the degree of freedom laboratories have to use lab-developed tests to improve patient care. Clin Chem Lab Med 2021;59:101–6. https://doi.org/10.1515/cclm-2020-0804.
1. Macintyre, E, Gribben, J, Döhner, K. EU-wide access to high-quality, affordable precision diagnostics: an EHA position paper. HemaSphere 2020;4:3. https://doi.org/10.1097/HS9.0000000000000412.
1. Dagher, G, Becker, KF, Bonin, S, Foy, C, Gelmini, S, Kubista, M, et al.. Pre-analytical processes in medical diagnostics: new regulatory requirements and standards. New Biotechnol 2019;52:121–5. https://doi.org/10.1016/j.nbt.2019.05.002.
1. CLSI. Quality systems regulations for laboratory-developed tests: a practical guide for the laboratory. CLSI document QSRLDT. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.

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[1] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj.

[2] Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Available from: https://eur-lex.europa.eu/eli/reg/2017/746/oj.

[3] Vermeersch, P, Van Aelst, T, Dequeker, EMC. The new IVD Regulation 2017/746: a case study at a large university hospital in Belgium demonstrates the need for clarification on the degree of freedom laboratories have to use lab-developed tests to improve patient care. Clin Chem Lab Med 2021;59:101–6. https://doi.org/10.1515/cclm-2020-0804.

[4] Vermeersch, P, Van Aelst, T, Dequeker, EMC. The new IVD Regulation 2017/746: a case study at a large university hospital in Belgium demonstrates the need for clarification on the degree of freedom laboratories have to use lab-developed tests to improve patient care. Clin Chem Lab Med 2021;59:101–6. https://doi.org/10.1515/cclm-2020-0804.

[5] Macintyre, E, Gribben, J, Döhner, K. EU-wide access to high-quality, affordable precision diagnostics: an EHA position paper. HemaSphere 2020;4:3. https://doi.org/10.1097/HS9.0000000000000412.

[6] Macintyre, E, Gribben, J, Döhner, K. EU-wide access to high-quality, affordable precision diagnostics: an EHA position paper. HemaSphere 2020;4:3. https://doi.org/10.1097/HS9.0000000000000412.

[7] Dagher, G, Becker, KF, Bonin, S, Foy, C, Gelmini, S, Kubista, M, et al.. Pre-analytical processes in medical diagnostics: new regulatory requirements and standards. New Biotechnol 2019;52:121–5. https://doi.org/10.1016/j.nbt.2019.05.002.

[8] Dagher, G, Becker, KF, Bonin, S, Foy, C, Gelmini, S, Kubista, M, et al.. Pre-analytical processes in medical diagnostics: new regulatory requirements and standards. New Biotechnol 2019;52:121–5. https://doi.org/10.1016/j.nbt.2019.05.002.

[9] CLSI. Quality systems regulations for laboratory-developed tests: a practical guide for the laboratory. CLSI document QSRLDT. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.

[10] CLSI. Quality systems regulations for laboratory-developed tests: a practical guide for the laboratory. CLSI document QSRLDT. Wayne, PA: Clinical and Laboratory Standards Institute; 2015.

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Complex analytical procedures in diagnostic laboratories and the IVDR

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Complex analytical procedures in diagnostic laboratories and the IVDR

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