Thursday, August 19th at 11am ET / 4pm London
In Part I, we covered a deep dive of into the published guidance on Legacy devices. As the MDR DoA (date of Application) has now passed, these are the devices that (if they meet specific criteria), can continue to be placed on the market for a period of time. As medical device manufacturers transition from the Medical Device Directives (MDD/AIMDD/IVDD) to the new regulations of the Regulation (MDR/IVDR), a new set of compliance rules and requirements come into play. We will do an in-depth walk-through of a ‘business use case’, describing the scenario, options and timelines. Registration of Legacy device versus Regulation compliant devices will also be reviewed.
This 30 minute presentation covers a business use case as one company assesses next steps based on their portfolio and sets expectations for MDR activity. Incoming questions from webinar Part I (recorded July 20, 2021) will also be discussed. We will review the following:
• Questions and comparisons of Regulation and Legacy Devices registration requirements
• MDR/IVDR Equivalent devices
• Business Use case
For regulatory teams working on EU MDR/IVDR data, this webinar will be a helpful walk-through of the main takeaways in the published information from the European Commission and the Medical Devices Coordination Group concerning Directive Devices that will continue to be placed on the market.
Gary Saner is a subject matter expert on medical device unique device identification and other structured content reporting to regulatory agencies and commercial organizations. He has over 30 years of experience in software development, process management and data administration with the last 15 years focused on the life sciences industry. 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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Unique Device Identification (UDI)
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