For IVDR compliance, Class D IVDs must transition to being compliant under the new regulation by 31 December 2027, Class C by 31 December 2028, and Class B and A-Sterile by 31 December 2029.

After several high-profile scandals surrounding medical devices, where irresponsible manufacturers’ malpractice in cutting corners showed how easy it was to abuse the Directive, the IVDR came ...

Importance of QIAGEN’s New Regulatory Achievement Securing IVDR certification for the QIAstat ... are classified as Class A ...

Within the EU IVDR, IVDs have been divided into four classes, based on both their intended purpose and its inherent risks. The four classes are: Class A (low individual risk and low public health ...

IVDR compliance certification further enhances ... FDA-approved companion diagnostic and continues to deliver world-class CDx products in close collaboration with pharma partners.

Biomerica, Inc. has achieved IVDR certification for its food intolerance products designed for managing Crohn's Disease and Ulcerative Colitis, marking a significant step in compliance with ...

March 10, 2025--(BUSINESS WIRE)--Agilent Technologies Inc. (NYSE: A) today announced its PD-L1 IHC 28-8 pharmDx kit has received two new companion diagnostic indications approvals under EU IVDR 1 ...