How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

doi:10.1016/j.cmi.2021.05.009

. 2021 Aug;27(8):1074-1075.

doi: 10.1016/j.cmi.2021.05.009. Epub 2021 May 9.

How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

Pieter Vermeersch¹, Emmanuel André²

Affiliations

¹ Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: pieter.vermeersch@uzleuven.be.
² Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.

PMID: 33979703
PMCID: PMC8106968
DOI: 10.1016/j.cmi.2021.05.009

How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

Pieter Vermeersch et al. Clin Microbiol Infect. 2021 Aug.

. 2021 Aug;27(8):1074-1075.

doi: 10.1016/j.cmi.2021.05.009. Epub 2021 May 9.

Authors

Pieter Vermeersch¹, Emmanuel André²

Affiliations

¹ Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Cardiovascular Sciences, KU Leuven, Leuven, Belgium. Electronic address: pieter.vermeersch@uzleuven.be.
² Clinical Department of Laboratory Medicine and National Reference Centre for Respiratory Pathogens, University Hospitals Leuven, Leuven, Belgium; Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium.

PMID: 33979703
PMCID: PMC8106968
DOI: 10.1016/j.cmi.2021.05.009

No abstract available

Keywords: COVID-19 testing; Diagnostic test approval; Europe; IVD; IVDR; In vitro diagnostic regulation; Lab-developed test; Medical device legislation.

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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. https://eur-lex.europa.eu/eli/reg/2017/746/oj Available from:
1. van Drongelen A., de Bruijn A., Pennings J., van der Maaden T. RIVM Letter Report 2018-0082; 2018. The impact of the new European IVD classification rules on the notified body involvement. A study on the IVDs registered in the Netherlands.
1. Vermeersch P., van Aelst T., Dequeker E.M. 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. Clin Chem Lab Med. 2020;59:101–106. - PubMed
1. Corman V., Landt O., Kaiser M., Molenkamp R., Meijer A., Chu D.K.W. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25:2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. - DOI - PMC - PubMed
1. Reusken B.E.M., Broberg E.K., Haagmans B., Meijer A., Corman V.M., Papa A. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020. Euro Surveill. 2020;25:2000082. doi: 10.2807/1560-7917.ES.2020.25.6.2000082. - DOI - PMC - PubMed

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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. https://eur-lex.europa.eu/eli/reg/2017/746/oj Available from:

[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. https://eur-lex.europa.eu/eli/reg/2017/746/oj Available from:

[3] van Drongelen A., de Bruijn A., Pennings J., van der Maaden T. RIVM Letter Report 2018-0082; 2018. The impact of the new European IVD classification rules on the notified body involvement. A study on the IVDs registered in the Netherlands.

[4] van Drongelen A., de Bruijn A., Pennings J., van der Maaden T. RIVM Letter Report 2018-0082; 2018. The impact of the new European IVD classification rules on the notified body involvement. A study on the IVDs registered in the Netherlands.

[5] Vermeersch P., van Aelst T., Dequeker E.M. 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. Clin Chem Lab Med. 2020;59:101–106. - PubMed

[6] Vermeersch P., van Aelst T., Dequeker E.M. 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. Clin Chem Lab Med. 2020;59:101–106. - PubMed

[7] Corman V., Landt O., Kaiser M., Molenkamp R., Meijer A., Chu D.K.W. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25:2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. - DOI - PMC - PubMed

[8] Corman V., Landt O., Kaiser M., Molenkamp R., Meijer A., Chu D.K.W. Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR. Euro Surveill. 2020;25:2000045. doi: 10.2807/1560-7917.ES.2020.25.3.2000045. - DOI - PMC - PubMed

[9] Reusken B.E.M., Broberg E.K., Haagmans B., Meijer A., Corman V.M., Papa A. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020. Euro Surveill. 2020;25:2000082. doi: 10.2807/1560-7917.ES.2020.25.6.2000082. - DOI - PMC - PubMed

[10] Reusken B.E.M., Broberg E.K., Haagmans B., Meijer A., Corman V.M., Papa A. Laboratory readiness and response for novel coronavirus (2019-nCoV) in expert laboratories in 30 EU/EEA countries, January 2020. Euro Surveill. 2020;25:2000082. doi: 10.2807/1560-7917.ES.2020.25.6.2000082. - DOI - PMC - PubMed

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How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

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How the European in vitro diagnostic regulation could negatively impact the European response to the next pandemic: an urgent call for action before May 2022

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