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Performance studies using in-vitro diagnostics (IVDR)
On 26 May 2022, EU Regulation 2017/746, also known as the In-Vitro Diagnostics Regulation (IVDR), entered into force.
IVDs must comply with the new European rules from May 26, 2022.
Information on the submission, review and conduct of performance studies on in vitro diagnostic medical devices (IVDs) can be found on the website of the CCMO.
Participating institutions: UMC Utrecht, Prinses Máxima Center for pediatric oncology and Antoni van Leeuwenhoek