INFORMATION ABOUT THE BASIC UDI DI
As it is known, in the Medical Device Regulation published in the Official Gazette dated 02.06.2021 and numbered 31499, Basic UDI DI is the primary identifier of a device model. It is the DI of the device assigned at the usage unit level. It is the master key of registrations in the UDI database and is referenced in the relevant certificates and EU declarations of conformity”.
Also in the “Guideline on Changes in MDCG 2018-1 v3 UDI-DI and Basic UDI-DI” published by the Medical Device Coordination Group, Basic UDI-DI “Basic UDI-DI, same intended use, risk class and basic design It is the master key in the database and related documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) for linking devices with manufacturing and manufacturing characteristics”.
Thermal UDI DI is included in the following documents;
Declaration of conformity
Free Sale Certificate
Safety and Clinical Performance Summary
Post-Market Clinical Research and Performance Study Applications
Vigilance and Post-Market Surveillance Report
The basic UDI DI is separate, independent of the device's packaging, labeling, and does not appear in any commercial product.
For the basic UDI DI assignment, 4 barcode assignment organizations are authorized under the MDR. Relevant organizations are listed below.
Health Industry Business Communications Council (HIBCC),
Informationsstelle für Arzneispezialitäten — IFA GmbH
Basic UDI DI assignment rules are included in the document named “MDCG Guidelines for Basic UDI-DI Rules of MDCG 2019-1 Allotment Organizations” published by the Medical Device Coordination Group. In this context, it is stated that the Basic UDI-DI code value will consist of a maximum of 25 characters, and the check digit/character will be a part of the Basic UDI-DI.
The link address containing the guide for barcode assignment rules and control character calculation pages of Basic UDI DI assignment organizations authorized by the EU Commission is shared below.