Key result
New European IVDR implementation requires urgent guidance for haemostasis testing, LDTs, and updated quality controls.
Why the study?
The new EU IVDR regulation replacing the previous IVD directives has significant implications for haemostasis and thrombosis testing, requiring analysis and guidance for clinical laboratories.
The implementation of the new EU IVDR regulation requires clinical laboratories to urgently adapt their haemostasis testing procedures, highlighting the need for clinical performance studies and updated guidelines.
Urgent IVDR guidance needed for haemostasis labs; leaves open standardized performance studies and LDT frameworks.
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.
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Testa et al. (2022) conducted a review in Haemostasis and thrombosis testing. New European regulation on in vitro diagnostic medical devices (IVDR) vs. Previous IVD directives (IVDD 98/79 EC) was evaluated. The implementation of the new European IVDR requires urgent guidance for haemostasis testing, including clinical performance studies, LDT guidelines, and updated quality controls.
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