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New report reveals ongoing industry challenges around EU’s IVDR and MDR compliance
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.
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Pharmacogenomics and IVDR: Overcoming transition challenges
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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Commercialising IVDs – The complex path towards access to early diagnosis
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 ...
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QGEN Stock to Gain From New IVDR Win for QIAstat-Dx Systems and Panels
Importance of QIAGEN’s New Regulatory Achievement Securing IVDR certification for the QIAstat ... are classified as Class A ...
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Biomerica Achieves IVDR Certification for Food Intolerance Products in European Market
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 ...
Business Wire6d
Agilent PD-L1 IHC 28-8 pharmDx Receives EU IVDR Certification as a Companion Diagnostic Test for Non-small Cell Lung Cancer and Melanoma Indications
IVDR compliance certification further enhances ... FDA-approved companion diagnostic and continues to deliver world-class CDx products in close collaboration with pharma partners.