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EU Regulation on medical devices for in vitro diagnostics applicable
IVDs must comply with new European rules from May 26, 2022. Specific rules for the submission, assessment and conduct of performance studies on in vitro diagnostic medical devices (IVDs) are laid down in the EU Regulation 2017/746, also known as the In Vitro Diagnostics Regulation (IVDR).
For more information, please visit CCMO's website: