According to the global initiative to prevent low-quality and falsified products from entering the legal supply chains, specific requirements are set for assigning a unique code to the packaging of each product and printing this code on the packaging by any method.
Pharmaceutical serialization is a process of assigning a unique serial number to each pharmaceutical package, goods can be identified and tracked throughout the entire pharmaceutical supply chain. Information including the product origin, expiry date, and the batch number could be identified and associated with the serial number, enabling Track and Trace from the production cycle to the end-user. Serialization and traceability can standardize and harmonize operational processes across manufacturers, parallel distributors, warehouses, 3PLs, hospitals, and pharmacies resulting in a synchronized workflow.
From 26th of May 2024 all medical devices placed on the market must be in conformity with the Medical Devices Regulation (MDR) (2017/745/EU) and In vitro Medical Devices Regulation (IVDR) (2017/746/EU). And that includes mandatory requirement of serialization.
Traceability has a key role in the monitoring, supervision, and improvement of the overall quality of medical devices and in-vitro devices.
Serialization, by assigning a unique serial number to a medical device despite its manufacturing origin around the world, is the first step for a traceability solution.
SoftGroup® SaTT EUDAMED Gateway (automatic connection) is a web-based service, part of SoftGroup® SaTT Cloud, that allows an automatic and secured connection, and data exchange between manufacturers and authorized representatives of medical devices, and the European database on medical devices (EUDAMED system).
SoftGroup® SaTT Labeling machine is a specially designed automatic machine for medical devices serialization with the capability to print on labels and verify the 2D Data Matrix and human-readable elements according to EU MDR requirements and GS1 standards. The machine provides second manual verification of the readability of 2D Data Matrix codes via a handheld barcode reader. The machine supports easy changeover of the label templates and different label designs.
SoftGroup® SaTT Labeling
machine with surface camera
SoftGroup® SaTT Labeling machine with surface camera is a specially designed automatic machine for medical devices labeling and serialization according to EU MDR requirements and GS1 standards. The machine is equipped with additional automatic verification of the readability of 2D Data Matrix codes via а surface camera, grading the quality of printed data after applying the labels. The machine supports easy changeover of the label templates and different label designs.