Category: IVDR
Urgent action needed to avoid widespread shortage of in-vitro diagnostic tests
In a new statement, BioMed Alliance highlights its increasing concern about the availability of In Vitro Diagnostic (IVD) testing devices in Europe.
New HemaSphere publication on IVDR implementation
The In Vitro Diagnostic medical devices Regulation (IVDR), which came in to force in May 2022 with the objective of safeguarding the quality and safety of diagnostic tests in the EU,…
New EU In Vitro Diagnostic medical devices Regulation (IVDR) comes into effect
On May 26, 2022, the new EU In Vitro Diagnostic medical devices Regulation (IVDR) came into effect, mandating stricter and more comprehensive certification and testing protocols for in vitro diagnostic…
Help disseminate IVDR Questionnaire - Share with diagnostic laboratories in your…
The new EU Regulation on in vitro diagnostic medical devices (IVDR) will come into full effect per May 26, 2022 and will have substantial consequences for diagnostic laboratories.