Dealing with the Current Delays in EU Medical Device Regulation: Town Hall Session

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. 

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Speakers

Gary Saner, Sr. Manager, Information Solutions Life Sciences, Reed Tech

Gary Saner is a subject matter expert (SME) on medical device unique device identification (UDI) and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in the areas of software development, process management and data administration, with the last 15 years focused on the life sciences industry. With an understating of regulations, business requirements and systems, he has helped shape and implement solutions at Reed Tech for data management, validation and processing of drug labeling and medical device UDI content. He serves as co-chair of the industry’s Structured Product Labeling Technical Team and on the Advisory Board of the Medical Devices Group.

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John Lorenc, Senior Manager Regulatory Solutions, Reed Tech

John Lorenc directs electronic submission and regulatory requirement initiatives that impact both the medical device and pharmaceutical industries. He has advanced experience with electronic drug product labeling and listing requirements and global UDI submissions. He participated as an industry resource in the original FDA pilot in 2012 and is currently focused on the present day requirements for EU UDI and South Korea and China. He represents Reed Tech in membership with MedTech Europe.

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