ADC and MDR, based on GS1 Standards
Multiple international legislations, such as UDI and MDR, are about to be implemented in Europe. These laws oblige the suppliers of medical devices to supply their products with a Unique Device Identifier (UDI). A British distributor was the first to ask Endoss for standardization. This distributor was, in turn, compelled by the National Health Service (NHS), with a deadline of October 2017. In England, the choice was made to implement these laws using the GS1 standard for barcodes, because GS1 is the accredited agency for UDI identification.
Nastasja Kuipers, international account manager: “We created a graduation project out of it. Michael Raats, studying MER at the AVANS Hogeschool, wrote a clear Thesis that we could implement directly. Amongst other things, he researched in different countries and at our clients how a supplier could best implement the standard.”
Kuipers and Vincent Van der Meer (Quality Assurance & Regulatory Affairs Specialist) emphasize that Endoss chose to implement the GS1 Standard. They aim to comply to the new impending legislations such as the ADC (Agreements Unique Coding) and MDR (Medical Device Regulation).