Roche Diabetes Care, as a manufacturer of medical devices, certified to European standards, complies with all applicable European directives. The lancing device is CE (Conformité Européene) labeled, which means that the product meets the safety and normative requirements of those European directives. The European regulations are valid and recognized under mutual recognition agreements with many countries, including Canada, LATAM, APAC and Japan. The lancing device also complies with laws such as the US Needlestick Safety and Prevention Act, the TRBA 250 (Germany) or the NR 32 (Brazil) and others.