Dealing with the Current Delays in EU Medical Device Regulation: Town Hall Session, Upcoming Webinar Hosted by Xtalks

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In this free webinar, the featured speakers will discuss the requirements of medical device registration processes for EU MDR and suggest best practices for EU EUDAMED product data management. They will explain the differences and similarities between FDA and EU UDI and the advantages of a comprehensive, global strategy for UDI compliance.

Xtalks Life Science Webinars

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.

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.

ABOUT XTALKS

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global life science, food and medical device community. Every year thousands of industry practitioners (from life science, food and medical device companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

To learn more about Xtalks visit http://xtalks.com
For information about hosting a webinar visit http://xtalks.com/why-host-a-webinar/

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Sydney Perelmutter
Xtalks
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