The European Commission has authored an information page on EUDAMED Actors registration module:
https://ec.europa.eu/health/md_eudamed/actors_registration_en
This module is used by medical device manufacturer, kit packer, importers, authorized representative to obtain a SRN (Single registration Number).
The module will be launched on 2020-12-01.
The ISO/IEC JTC1/SC31 meeting took place virtually in Cape Town. Please find the report in the report section.
(Picture:Xiaoyu YOU,CAICT)
In the "Identifier Forum" of the conference, the connection between the physical flow of goods and electronic communication was discussed and the crucial role that unique identification plays.The eEuropean Medical device manufacturer association published a very helpful document about the assignment of the Basic UDI-DI (BUDI):
https://www.medtecheurope.org/resource-library/medtech-europes-guidance-on-basic-udi-di-assignment/
We want to express our thanks to Medtech Europe.
The following article resumes the developpment of the GS1/HIBC BUDI checksum:
Die IFA GmbH wurde mit dem Durchführungsbeschluss von der EU Kommission vom 6. Juni 2019 als Zuteilungsstelle für UDI-DI benannt. Eine nach dem IFA Coding System auf der Packung kodierte Pharmacy Product Number (PPN) stellt damit eine MDR-konforme UDI-DI dar.
Weitere Informationen hier:
