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FDA-Cleared 12-Panel At-Home Drug Test Kit Empowers Families and Workplaces with Rapid Screening
2025-06-01
Conlight Diagnostics launches an FDA 510(k)-cleared immunoassay urine cup test, enabling self-administered screening for 12 common drugs of abuse in under 10 minutes.
Shanghai, China - June 2025
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The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application
2025-05-16
In March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent ...
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The Shift from IVDD to IVDR—and the Challenges
2025-05-08
The shift from IVDD to IVDR represents a major change in how the IVD industry is regulated. While the EU Commission maintains that the system’s overall structure and approach remain consist...
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The In Vitro Diagnostics (IVD) market is undergoing significant transformation
2025-03-07
The In Vitro Diagnostics (IVD) market is undergoing significant transformation, driven by technological advancements, shifting market dynamics, and evolving regulatory landscapes. As we navigate th...
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In Vitro Diagnostic Regulation (IVDR)
2025-03-07
The In Vitro Diagnostic Regulation (IVDR) replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of applicationIn March 2023, the IVDR was amended as regards to transition...
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detail