Implementation of the new <scp>EUR IVD</scp> regulation and relation with <scp>ISO15189</scp> accreditation: Guidance is urgently required for haemostasis testing-Reference-Cited by-同舟云学术

Implementation of the new EUR IVD regulation and relation with ISO15189 accreditation: Guidance is urgently required for haemostasis testing

Published:2022-09 Issue:S1 Volume:44 Page:71-78
ISSN:1751-5521
Container-title:International Journal of Laboratory Hematology
language:en
Short-container-title:Int J Lab Hematology

Author:

Testa Sophie¹^ORCID,Meijer Piet²,Lasne Dominique³^ORCID,Mullier François⁴

Affiliation:

1. Haemostasis and Thrombosis Centre Cremona Hospital Cremona Italy

2. ECAT Foundation (External Quality Control for Assays and Tests) Voorschoten The Netherlands

3. Haematology Laboratory AP‐HP, Hôpital Universitaire Necker‐Enfants Malades Paris France

4. CHU UCL NAMUR, Namur Thrombosis and Hemostasis Center (NTHC) Université Catholique de Louvain Yvoir Belgium

Publisher

Wiley

Subject

Biochemistry (medical),Clinical Biochemistry,Hematology,General Medicine

Link

https://onlinelibrary.wiley.com/doi/pdf/10.1111/ijlh.13936

Reference59 articles.

1. Precision Medicine — Personalized, Problematic, and Promising

2. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices.https://eur-lex.europa.eu/legal-content

3. Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices.http://data.europa.eu/eli/dir/1998/79/oj

4. The EU's system for regulating medical devices

5. The scandal of device regulation in the UK

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