The European Database on Medical Services (EUDAMED) launch, delayed until May 2022, will support both medical devices and in vitro diagnostic devices, but there are certification processes required for MDR that are not delayed.
TORONTO (PRWEB) May 06, 2020
Due to impacts of the COVID-19 pandemic, the European Union (EU) Medical Device Regulation (MDR) Date of Application (DoA) has been delayed to 26 May 2021. Nevertheless, compliance preparation activity will continue to need detailed attention. Is the EU MDR certification plan and supporting documentation ready? Are there uncertainties on known requirements or timing?
The European Database on Medical Services (EUDAMED) launch, delayed until May 2022, will support both medical devices and in vitro diagnostic devices, but there are certification processes required for MDR that are not delayed. These certifications require documentation and product data, including Basic Unique Device Identification-Device Identifier (BUDI-DI).
This webinar is provided in a Town Hall format with an introductory presentation on current status, what has been learned via EUDAMED device registration testing and an extended Q&A session. Specific questions can be submitted concerning medical device registration scenarios, as well as BUDI-DI and EU UDI data elements and requirements. The speakers will review and provide clarity on currently posted guidance and answer questions on the differences between the FDA Global Unique Device Identification Database (GUDID) and EU EUDAMED.
Join Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech and John Lorenc, Senior Manager Regulatory Solutions, Reed Tech in a live webinar on Thursday, May 21, 2020 at 11am EDT (4pm BST/UK).
For more information or to register for this event, visit Dealing with the Current Delays in EU Medical Device Regulation: Town Hall Session.
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