Standards

Manufacturers of medical products must observe a number of obligations, noted in the Medical Devices Act and in different standards.

Standards apply to ensure safety and health protection of patients and users of medical devices. These guidelines that are released by the German Institute for Standardization (DIN) give important recommendations for the user-friendly conception and development of user interfaces.

According to the new medical engineering standard DIN EN 60601-1-6 and EN 62366, the usability engineering process for the development of medical devices must be conducted and documented following certain specifications. Thus, a standard-compliant usability file is the prerequisite for the certification by a notified body. To provide standard-compliant products, manufacturers also have to document the risk management process in a risk management file according to ISO 14971:2007.