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Hemasphere. 2021 Apr 21;5(5):e568. doi: 10.1097/HS9.0000000000000568. eCollection 2021 May.

The New EU Regulation on In Vitro Diagnostic Medical Devices: Implications and Preparatory Actions for Diagnostic Laboratories.

HemaSphere

Bart R Lubbers, Anke Schilhabel, Christa M Cobbaert, David Gonzalez, Isabel Dombrink, Monika Brüggemann, W Marieke Bitter, Jacques J M van Dongen

Affiliations

  1. Department of Immunology, Leiden University Medical Center, Leiden, The Netherlands.
  2. Department of Hematology, University Hospital Schleswig-Holstein, Kiel, Germany.
  3. Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, Leiden, The Netherlands.
  4. Centre for Cancer Research and Cell Biology, Queen's University Belfast, Belfast, United Kingdom.

PMID: 33898932 PMCID: PMC8061679 DOI: 10.1097/HS9.0000000000000568

[No abstract available.]

References

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  2. Hemasphere. 2020 Jun 08;4(3):e412 - PubMed
  3. Clin Chem Lab Med. 2020 Dec 11;59(3):457-458 - PubMed
  4. Lancet. 2018 Aug 11;392(10146):521-530 - PubMed
  5. Clin Chem Lab Med. 2020 Nov 23;: - PubMed
  6. Clin Chim Acta. 2014 Jan 1;427:49-57 - PubMed

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