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.