UDI Marking

UDI Marking

UDI Regulations and Requirements

A directive from the United States Food and Drug Administration (FDA) and the European Commission has introduced legislation regarding the Unique Device Identification (UDI) of medical devices and instruments. From September 2016, all medical class III devices and instruments that require direct part marking (DPM) must also carry a UDI. Class II and Class I devices will require UDI from September 2018 and September 2020 respectively.

This system will allow greater accuracy in reporting and traceability as well as reducing medical errors by allowing health care workers to quickly identify instruments.

Why Laser Marking is an Effective and Suitable Solution



Permenant mark capable of lasting product life span

High contrast marking

Sterilisation resistant

Hygienic and smooth

Uneffected by passivation or other surface treatment

How Pryor can help with UDI

Pryor has a strong background in working with medical device and instrument manufactures and have developed our own laser and traceability solutions tailored towards UDI requirements.

Our expertise in the intergration of vision systems is unmatched in the marking industry. This enables us to validate and verify against industy standards, and even produce full reports and images of the process for a complete traceability and data capture solution.

We can offer the following benefits to our medical customers:



Full traceability and serialisation to ensure unique part marking

Mark Logos, serial numbers, 1D barcodes, 2D data matrix

Cognex integration for full part mark verification

Marking and quality inspection become a single operation, reducing critical cycle time

Customised software for UDI applications

Possibility to network our machines to your manufacturing execution system (MES)