MANDATORY REGISTRATION AND PRESERVATION OF THE UDI CODE
Dear Customer,
in view of the entry into force, as of January 15, 2024, of the obligation for the dental implants to register and keep the UDI code by the operators, we would like to clarify that this registration must take place only for devices registered according to MDR 2017/745 regulations.
Titanmed has certified its devices still according to MDD 93/42CEE, so they do not fall under this obligation.
Precisely because we are working to comply with the MDR regulation, we have, in our warehouses, the presence of production lots with a label in which there is no UDI code (Ex.1) and production lots with a label bearing UDI codes (Ex.2).
Our customers must continue to apply the traceability system applied so far, record the lot number and CE marking, or more simply apply the labels that come with our devices, on the medical record and implant passport that will be delivered to the patient.
It will be our concern, upon obtaining MDR 2017/745 certification, to give notice and guidance on the registration requirements for our devices.
Titanmed's quality office remains available for any clarification: tel: 0341 363504 int. 4; email: quality@titanmed.it.
Kindest regards
Titanmed Srl
