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
- Permanent mark capable of lasting product life span
- High contrast marking
- Sterilisation resistant
- Hygienic and smooth
- Unaffected by passivation or other surface treatment
How Pryor can help with UDI
Pryor has a strong background working with medical device and instrument manufacturers and have developed our own laser and traceability solutions tailored towards UDI requirements.
Our expertise in the integration of vision systems is unrivalled in the marking industry. This enables us to validate and verify against industry standards, able to 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)