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 in order 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. IVDR retains some concepts of IVD Directive such as CE marking or essential requirements (under IVDR called “general safety and performance requirements”). As in the past, the manufacturers have to demonstrate that they and their devices meet the requirements through conformity assessment procedure. Different from IVD Directive, however, IVDR introduced the riskbased classification (Figure 1).

Under IVDR devices are classified in four: The devices with highest risks are classified in class D. The class A devices have low risks and include products for general laboratory use, accessories which possess no critical characteristics.

The paper is available for downloading through the following link: