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New report reveals ongoing industry challenges around EU’s IVDR and MDR complianceFor 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 ...
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Zacks.com on MSNQGEN Stock to Gain From New IVDR Win for QIAstat-Dx Systems and PanelsImportance 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 ...
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