What is a significant change? New MDCG Guidance for IVD legacy devices

The new Regulation on in vitro medical devices (IVDR) will start to apply on May 26, 2022. For manufacturers, we want to highlight two crucial points. The first aspect concerns the transition periods: manufacturers can place their IVD compliant devices after May 26, 2022 under certain conditions and only until the respective (delete: different) different transition periods end (the so-called “grace period”). The second key information regards the characteristics and requirements under which manufacturers can place their devices on the . . .


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