The European Union’s Regulation on in Vitro Diagnostic Medical Devices, commonly referred to as IVDR, replaces the EU’s former directive on in vitro medical devices (IVDD). The new regulation means major changes to how IVD manufacturers obtain CE Marking and maintain access to the European market.

We’re proud to say that Precision BioLogic is IVDR-ready.

We received our IVDR QMS certification on June 19, 2023, and the following CRYOcheck™ products are IVDR-compliant:

• Pooled Normal Plasma
• Normal Reference Plasma
• Reference Control Normal
• Abnormal 1 Reference Control
• Abnormal 2 Reference Control
• Lupus Positive Control
• Weak Lupus Positive Control
• Lupus Negative Control
• Factor II Deficient Plasma
• Factor V Deficient Plasma
• Factor VII Deficient Plasma
• Factor VIII Deficient Plasma
• Factor VIII Deficient Plasma with VWF
• Factor IX Deficient Plasma
• Factor X Deficient Plasma
• Factor XI Deficient Plasma
• Factor XII Deficient Plasma
• LA Check™
• LA Sure™
• Factor VIII Inhibitor Kit
• Chromogenic Factor VIII
• Chromogenic Factor IX
• Hex LA™

Our IVDR Quality Certificate, along with our other quality certificates, is available from the Quality Management section of our website.

View a list of our international distributors.