UDI

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.

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The ISO/IEC JTC1/SC31 meeting took place virtually in Cape Town. Please find the report in the report section.

 Foto Vortrag Xiaoyu YouCaict

(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.

 210224 SCreenshot public udi vddi 2021 people

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

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

E-D-C registers and maintains ISO/IEC 15459-2 compliant "Company Identification Codes (CIN)". From now on, each new CIN from E-D-C will get a certificate that includes ISO/IEC 20248 Digital Signature (DigSig) in the form of a QR code. The QR contains a DigSig URL. If the QR is scanned and the URL is posted to the Internet, then the verification data of the owner of the CIN will be accessed and the validity information to the registered ID will be opened automatically.

 DigSig Certificate PIC 210714

This solution for verification of a CIN (used for globally unique marking and identification of products, locations, processes, etc.) was realized with the help of IT service provider and specialist in authentication and verification "TRUEVOLVE", Cape Town (SA). TRUEVOLVE is hosting the DigSig domain for the verification process (https://www.truevolve.com).


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.

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:

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