What is the New EU In Vitro Diagnostic Regulation (IVDR)?

In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 | Photo: Shimadzu Benelux

What is the New EU In Vitro Diagnostic Regulation (IVDR)?

New In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 was published in EU Official Journal in May 2017 to ensure a high level of safety and health whilst supporting innovation.

It applies from 26 May 2022 and replaced the previous IVD Directive (98/79/EC). This regulation set rules for in vitro diagnostic devices such as reagent, calibrator, kit, instrument, and software intended by the manufacturer to be used for diagnostic purposes.

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Shimadzu Benelux

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