EUDAMED is one of the hot Regulatory topics that have shifted over the last year. It is time now to take attention. The first module will be launched at the end of 2020, just to remind you that is between now and 8 weeks. The first module will be on Economic Operator (EO) registration and will be on voluntary basis. The EO’s are manufacturers, system/procedure pack producers, authorized representatives and importers.
It is important to start the registration of EO as soon as the system is available (currently planned for December 2020), for the reason that the EO’s need a SRN (Single Registration Number). Only if you have a SRN it will be possible to utilize other EUDAMED modules and to apply for conformity assessment. The advantage to undertake the voluntary EO registration now is that manufacturers can wait without time pressure on the validation of the registration by the competent authority (CA). The EUDAMED modules on device & UDI registration and on certificates & notified bodies are planned to be launched by May 2021.
Learning Objectives of this Webinar:
- Introduction to EUDAMED
- EUDAMED readiness and timelines
- Data needed in the EO registration module for all actors
- Data needed in the device & UDI registration module
- practical guidance on operating EUDAMED, including outsourcing registrations