The transition to a new regulatory framework for in vitro diagnostic medical devices in the European Union

This document provides an overview of the transition period from the IVD Directive 98/79/EC to the IVD Regulation (EU) 2017/746. It explains the impact for in vitro diagnostic (IVD) medical devices being placed on the market during the transition period.

Summary:

• From May 2017 to May 2022, IVDs will start to transition from being CE marked under the current IVD Directive 98/79/EC to being CE marked under the new IVD Regulation (EU) 2017/746.
• However, the transition may last until at least May 2024 for those IVDs that are certified by a Notified Body under the current Directive.  No new certifications under the current Directive can take place after 26 May 2022.
• EU Member State authorities and Notified Bodies will continue to oversee the EU market, ensuring that all IVDs are fit for purpose and reliably provide information to be used for diagnostic purposes, regardless of whether they are CE marked under the current Directive or the Regulation.
• An IVD is not inferior simply because it is CE marked under the current Directive instead of under the new Regulation.
• Regulatory documentation – such as Declarations of Conformity, certificates, labels and instructions for use – issued under the current Directive, may remain valid until up to approximately May 2024, and can both continue to be used and will lawfully remain in circulation.