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The European Commission have designated five EU reference laboratories for high-risk in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2023/2713. These labs will enhance conformity assessments and advisory tasks for devices related to critical health areas like hepatitis, retroviruses, bacterial agents and life-threatening respiratory viruses. The labs are expected to start testing IVDs from October 1, 2024, for tasks outlined in Article 100(2) of Regulation (EU) 2017/746 (EU IVDR). This initiative, under Regulation (EU) 2017/746, marks a significant step in standardizing and elevating healthcare device safety.

 

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