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.
Click here to see the contribution of Harald Oehlmann.

 

The virtual event, which was attended by about 100 participants, aimed at updating information on UDI implementation in accordance with the Medical Devices Act. The topics ranged from UDI-compliant marking to the required product registrations in the UDI database EUDAMED to the practice at the manufacturer site. The summary provides an overview on UDI and its implementation specialities for Europe. Additional information can be found in the UDI book published by Beuth-Verlag, second edition, for details on UDI (see link below).

Technical questions can be sent to the speakers by email: This email address is being protected from spambots. You need JavaScript enabled to view it..

Link for access and trial reading of the UDI book II:https://www.beuth.de/de/publikation/udi-unique-device-identification/320019099

Summary of the "virtual" 28th HealthCare Barcode User Day

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.