New regulations have been introduced that require a different type of identification code for medical products. Our packaging has changed to reflect this.
What is the Unique Device Identification for medical devices?
New regulations have been introduced that require a different type of identification code for medical products to the traditional barcode that our products previously had. The Unique Device Identification (UDI) is a series of numeric or alphanumeric characters that is used to show the identification of a medical device on the market. In essence, the UDI allows for the capability to recognise, track individually, and locate specific medical devices through the supply chain and, importantly, into a patient pathway. This facilitates easier traceability of medical products and considerably improves the efficiency of the post-market safety-related activities for devices to allow for better monitoring by the competent authorities.
What products will it affect?
Unigloves’ medical grade disposable gloves on both the inner cartons and outer cases. The UDI is the same as the previous identification, but it is now bundled together with the lot number, manufacturing date and expiry date into a new style of barcode, which is a QR format. The UDI is in addition to the traditional barcode and will apply to both the inner cartons and outer cases, only affecting medical products. There is no change to non-medical gloves.
When will this change happen?
Two new regulations (Regulation (EU) 745/2017 on medical devices and Regulation (EU) 746/2017 on In Vitro diagnostic medical devices) come into force on 26th May 2021. The new stock is being phased into our supply chain.