Implementation of the new EUR IVD regulation and relation with ISO15189 accreditation: Guidance is urgently required for haemostasis testing.
CE-IVD
ISO15189
IVDR
fibrinolysis
haemophilia
haemostasis
lab developed test
lupus anticoagulant
platelet function testing
research-use-only
Journal
International journal of laboratory hematology
ISSN: 1751-553X
Titre abrégé: Int J Lab Hematol
Pays: England
ID NLM: 101300213
Informations de publication
Date de publication:
Sep 2022
Sep 2022
Historique:
received:
20
04
2022
accepted:
24
06
2022
entrez:
8
9
2022
pubmed:
9
9
2022
medline:
14
9
2022
Statut:
ppublish
Résumé
On May 26th 2017 the European Parliament and the Council of The European Union adopted the new regulation on in vitro diagnostic medical devices (IVDR)-Regulation EU 2017/746-planned to be applied from May 26th 2022 in substitution to the previous IVD directives (IVDD 98/79 EC). After several health and legal causes due to medical device malfunctions, the European Union (EU) extensively reviewed the previous regulatory, which had remained unchanged since 1998. Aim of the work is to analyse the effects of the new IVDR on the field of haemostasis and thrombosis testing with particular attention to specific clinical conditions. Clinical laboratories will mainly deal with three different situations: (1) Diagnostic test performed with IVDR products used according with clinical indication certified by manufacturers. (2) Diagnostic test performed with certified IVDR products without clinical validation. (3) Diagnostic test performed with reagents classified as Research Use Only (RUO). At present, only few clinical laboratories through different European countries have been prepared to the new IVDR, while many laboratories are not yet aware about crucial aspects of the new process that deeply involves laboratory medicine. In conclusion, each laboratory should be aware of the IVDR certification of the reagents/instruments used in its laboratory. There are several urgent needs regarding IVDR certification: studies about the clinical performance of haemostasis tests, guidelines for LDTs (definition and documentation), internal and external quality controls for the tests recommended/suggested in the guidance/guidelines and finally implementation and/or update of clinical and laboratory guidelines.
Substances chimiques
Reagent Kits, Diagnostic
0
Types de publication
Journal Article
Review
Langues
eng
Sous-ensembles de citation
IM
Pagination
71-78Informations de copyright
© 2022 John Wiley & Sons Ltd.
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