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. Understanding the applicable scenarios, provisions for registration and the timing for each become important.
This presentation will cover ‘what to know’ concerning the category of ‘Legacy Devices’. Now that the MDR Date of Application has passed, these are the devices that (if they meet specific criteria), can continue to be placed on the market for a period of time. Legacy device registration is handled differently than Regulation compliant devices.
We are taking a deep dive into the published guidance and will illuminate some key areas:
• Legacy Directive Device definition, criteria and requirements
• MDR/IVDR Equivalent devices
• Compliance timelines based on scenario
• Legacy device reporting to the 6 modules of EUDAMED
• Compare Regulation and Legacy Devices registration requirements
• Compare and contrast Basic UDI-DI and UDI-DI to EUDAMED-DI and EUDAMED-ID
• Business Use case