Review a webinar featuring Reed Tech subject-matter experts and some of our industry friends and colleagues on preparing data for EUDAMED.
Panelists from Reed Tech, GMDN Agency, Greenlight Guru and Vyaire Medical engage in a roundtable discussion of questions from regulatory compliance teams on EUDAMED status as of Oct 2021.
Register for this webinar for a virtual panel discussion of some of the critical questions being asked about medical device requirements for global health authorities with special emphasis on EU EUDAMED. The panel will discuss topics like:
- What should I know about existing CE marking and future requirements?
- For IVDR, who decides what class a product falls into and can I ‘self-certify’ under the IVDR?
- Are there some products that have resulted in reclassification to a ‘higher class’ for EU-MDR, what are some examples?
- When the UDI/Device Registration Module opens, will EUDAMED already be populated with existing ‘Directive’ device info? If I participate in the voluntary period, does that count as an ‘official’ submission or do I re-submit when EUDAMED goes live?
- For EUDAMED device registration, what is the difference between Regulation and Legacy requirements?
- What Quality Management changes need to occur to comply with MDR/IVDR?
- What are the main differences between GMDN and EMDN? Is mapping available between the two standards?