The new regulation is a fundamental revision to better control and identify medical devices products and improve safety and transparency through clear accountabilities, standard processes and data, technological advances and the establishment of an EU database (Eudamed).
PRISYM ID’s print on demand solution, has enabled this blue chip medical device provider to print single-language Instructions for Use (IFU) at the time of shipment. This means that rather than their manufacturing sites including 23 Language IFUs with the product, they can instead print a country-specific IFU based on the intended destination of each product, and add it to the package at the time of shipment.
Managing change is a constant challenge. This is particularly true in life science industries where regulatory changes, product innovations and the drive to achieve supply chain efficiencies are ever present.