The EU MDR (EU 2017/745) date of application, 26 May 2021, is quickly approaching, and if your 2021 distribution strategy involves marketing medical devices in the European Union, it is critical to have a plan for submitting UDI data in compliance with the EU MDR. With the EU MDR following the FDA’s lead in requiring a UDI, regulatory affairs teams must be ready to update many of their processes to be able to register their products in the EUDAMED database. Additionally, certain best practices should be followed for creating structured device registration and Unique Device Identification (UDI) data, as well as for implementing EU MDR compliant product labels in order to comply with the date of application (DoA) requirements.
Your RA/QA team needs a solidified plan of action for how you will address these expanded regulations. Join us to hear from the perspective of our medical device subject matter experts, John Bradsher and Sharma Pokkuluri.