News Official start of the EU MDR: May 26, 2021
Since the end of May 2021, the UDI (Unique Device Identification) enables the unique identification and secure traceability of medical devices as part of the European MDR (Medical Device Regulation) and improves patient safety.
Deadlines for Direct Marking
On May 26, 2021, the MDR (Medical Device Regulation) officially came into force for Europe. This also marked the start of the regulations, deadlines and the obligation for UDI direct marking of medical devices. In the below table, we summarize the implementation deadlines for the MDR start in a nutshell:
|Direct marking of re-usable products (MDR Article 123 (3) (g), Article 27 (4)*|
|Implantable products and Class III products||must be marked directly with the UDI code as of 26.05.2023|
|Class IIa and Klasse IIb products||must be marked directly with the UDI code as of 26.05.2025|
|Class I products||must be marked directly with the UDI code as of 26.05.2027|
If you have any further questions regarding the laser marking of the above mentioned medical devices subject to UDI, please do not hesitate to contact us
We will be pleased to support you at any time with the laser marking of your medical devices in compliance with the regulations.