Regulatory frameworks for medical devices mandate a Unique Device Identifier (UDI) system be put in place to allow for identification and facilitate traceability of devices. To ensure all markings on a medical device or its’ packaging continues to meet labelling regulatory and statutory requirements throughout its lifetime we perform assessments to validate their readability and durability.
Unreadable and misread barcodes can cause a breakdown in the supply chain, delaying deliveries and even put patients at risk meaning that verification should be considered as part of the risk management of a device. This can include ensuring that the etching/marking process successfully produces a compliant barcode or testing the corrosion and/or fading of the markings due to stresses that could occur during its life cycle.
With the changes in technology there are now a range of types of barcodes and different printing/finishing methods that can be selected to add markings containing essential information to devices and their packaging. When selecting the method to be used during production, the manufacturer must ensure there is no negative impact on product safety or interfere with the effectiveness of the device throughout the life cycle of the product. Once this has been selected, the quality and compliance against the requirements must be repeatably produced as well as withstand different stresses the product may be exposed to.