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