arcoro Glossar

Regulatory Affairs

Regulatory Affairs examines national and international laws and regulations in relation to standards and policies that are required for the approval of medical devices. The Medical Device Directive, the MDR and the MEDDEV guidelines are the most decisive guidelines. In order to remain competitive as a manufacturer, a well-founded and continuous update of the state of knowledge about all practiced regulations and standards is required for the purpose of applying them accurately to the product categories, their markings and tests before and after the market launch. Additionally, the creation and maintenance of the technical documentation must meet the underlying requirements of the MDR.