Transition to EU IVD Regulation (EU) 2017/746 and considerations for non-EU regulatory authorities on managing the impact to product registrations

More than 31,000 in vitro diagnostic medical devices (IVDs) are expected to transition to the European Union’s (EU) in vitro diagnostic medical devices Regulation (IVDR) 2017/746 within the next years. Non-EU regulators will see changes to these devices’ regulatory documentation and labelling arising from the transition to EU IVDR. Because so many of these devices are transitioning around the same time, it is important for non-EU regulators to consider how to minimise disruption to the supply of IVDs in their country:

• In most cases, changes to regulatory documentation and labelling do not impact on the device’s safety and performance – it will be the same IVD medical test with updated information.
• A pragmatic approach may be needed for handling e.g. change notification applications or other national regulatory requirements.

This document identifies considerations that can be shared with non-EU regulators on the recommended approach for handling changes deriving from the transition to the new EU regulatory framework. It builds on the experience gained so far with the transition as well as on a previous MedTech Europe’s publication which informed about the nature of the changes and their relevance for international registrations.