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EC Plans New Structures For Manufacturers Of High-Risk IVDs Soon

 
• By Amanda Maxwell

Among the missing elements of the EU IVD Regulation are designated reference laboratories, which are to play a key role in assessing class D IVDs. That should change by around early 2024.

IVDs
• Source: Shutterstock

The European Commission has shortlisted five EU reference laboratories for designation in the context of the IVD Regulation, and an implementing act finalizing the designations is expected by the end of 2023.

The EURLs should then start fulfilling their role in the conformity assessment of devices several months after designation. 

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