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Since the first, publicly viewable proposal of the EU for the Medical Device Regulation in 2012, over the publication of the final version in the EU Official Journal in 2017 and the postponement in…

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Scientific validity refers to the association of an analyte with a specific clinical or physiological condition. The IVDR demands that this relationship is scientifically proven. Scientific…

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Performance evaluation is an essential part of the life cycle of an IVD. It follows a well-defined and methodologically sound procedure and comprises evidence of scientific validity, analytical…

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