Medical device product data management and health regulator news is always on the agenda here at Reed Tech. Our product managers recently gave a comprehensive update on key dates and requirements by region including South Korea MFDS, China NMPA, UK and others. We then reviewed the latest published news on EUDAMED and took a deep dive into the complexities of the dataset and how it differs from US FDA.
Activity is underway! The Actor Module went live at the end of 2020 and the database ‘playground’ became available again at the end of March 2021 for continued testing of data and business rules. The date of application (DOA) for the (MDR) Medical Device Regulation is going into effect on 26 May 2021.
In this one-hour presentation, we reviewed UDI preparation steps for EU EUDAMED with a short list of tasks that can be accomplished now. The latest in key timelines for MDD/AIMDD/IVDD Devices, Legacy Directive Devices and MDR/IVDR Compliant Devices were discussed. The main takeaway is getting ‘prepared now’. Locating data and making decisions on infrastructure and next steps takes planning.
You are invited to register to gain access to the one-hour recording and the informative slides that accompany the presentation.
- Preparing for EUDAMED UDI submissions
- What to know for EUDAMED device registration
- An update on other global health authorities
- How Reed Tech can help
Published guidance continues to develop for health authorities and can be quite nuanced from past learnings with the US FDA experience. Get in touch with Reed Tech to see how product data management can be handled with flexible team roles and data validation tools in a dedicated solution like Reed Tech SingleSource™ for Medical Devices.
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