Using Laser Marking For Traceability in the Medical Industry

Unique Device Identification (UDI) is a standardisation system implemented by legislation by the Food and Drug Administration (FDA) in the USA and the European Commission in Europe, for identification in medical production. Since 2020 all classes of medical devices have been required to be marked with a UDI and from May 2021 the EU will require the same standardisation.

A UDI is a mark consisting of two parts, this needs to be two codes, one that is machine-readable and the other is readable by humans. The machine-readable part is a 2D data matrix code or a linear barcode, the human-readable part is comprised of numbers and letters.

Why Laser engrave UDI CODES?

Medical devices are made from all sorts of materials and have a variety of uses, many surgical instruments such as scalpels are made of steel, cobalt or ceramics whereas dental implants are made of titanium. It is essential that these materials are not weakened and the surface state is not changed when marking the UDI, the window for precision is also small but requires a high definition of detail to allow both codes to be identified by machines and humans alike. 

Direct Part Marking (DPM) with an N-Lase Laser System allows for a permanent, legible and consistent mark that complies fully with the FDA and EC standards. As medical devices will see an amount of wear and abrasion as well as frequent sterilisation cycles, other marking technologies on this equipment will not be as efficient or effective (e.g. Ink marking) as the transferred ink will deteriorate over time and washes.

Laser Marking medical instruments and devices allow for a permanent, tamper-proof mark that can be achieved quickly by an environmentally sustainable process. Our N-Lase Desktop Pro provides this solution to ensure that all medical devices comply with the FDA and EC UDI requirements. If you are looking for a solution to fit into your current production line or you are looking to mark larger parts or larger marks then our N-Lase Integrated could be the best fit for your business.