As is known, in the Medical Device Regulation published by the Official Gazette No. 31499 dated 02.06.2021, the Basic UDI DI “is the primary identifier of a device model. It is the DI assigned at the unit level of use of the device. It is the main key to registration in the UDI database and is referenced in the relevant certificates and EU declarations of conformity”.
Again, the medical device Coordination Group “published by MDCG 2018-1 v3 UDI-Di and the underlying changes in the UDI-Di is a guide for the” also Basic UDI-DI “Basic UDI-DI, with the same purpose, risk class, and the basic design characteristics and manufacturing devices to connect to the database and the related documentation (eg. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance are the main keys”.
The Termel UDI DI is contained in the following documents;
Technical File
Declaration of Conformity
Product Certification
Certificate of Free Sale
Summary of Safety and Clinical Performance
Clinical Research and Performance Study Applications after Market Supply
Vigilance and Post-Market Surveillance Report
The basic UDI DI is separate, independent of the device's packaging, labeling, and does not appear on any commercial product.
4 Barcode assignment organizations have been authorized under the MDR for basic UDI DI assignment. The following are the relevant organizations.
GS1 AISBL,
Health Industry Business Communications Council (HIBCC),
ICCBBA
Informationsstelle für Arzneispezialitäten — IFA GmbH
The Basic UDI DI assignment rules are included in the document titled “MDCG Guidelines on the Basic UDI-DI Rules of MDCG 2019-1 Allocation Organizations” published by the Medical Device Coordination Group. In this context, it is stated that the Basic UDI-DI code value will consist of no more than 25 characters, and the control digit / character will be part of the Basic UDI-DI.
The link address of the guide to the barcode assignment rules of the Main UDI DI designation organizations authorized by the EU Commission and the control character calculation pages are shared below.
GS1 :
https://www.gs1.org/docs/barcodes/GSCN_19-012_GlobalModelNumberUpdate_v3.pdf
https://www.gs1.org/services/gmn-generator
PERFORMANCE;
https://www.ifaffm.de/mandanten/1/documents/04_ifa_coding_system/IFA-Info_Spec_UDI_Code_EN.pdf
https://www.ifaffm.de/mandanten/1/documents/04_ifa_coding_system/IFA-Info_Check_Digit_Calculations_PZN_PPN_UDI_EN.pdf
HIBC;
https://www.hibcc.org/wp-content/uploads/HIBCC-Basic-UDI-DI.pdf
https://www.hibcc.org/basic-udi-di-generator/
ICCBBA
https://www.iccbba.org/standard-coding-and-labeling-medical-devices2
The translations of the guidance documents published by the Medical Device Coordination Group prepared by our institution can be found at the link below.
https://www.titck.gov.tr/faaliyetalanlari/tibbicihaz/tibbi-cihaz-mevzuati
Source:https://uts.health.gov.en/?p=3267
22 Oct 2021
