As part of the Notified Body assessment, a manufacturer must develop technical documentation in order to properly evaluate their device, and establish a quality management system that meets the requirements of the Directive. Manufacturers must also comply with EU Regulation 722/2012 regarding the use of materials of animal origin and which requires manufacturers to utilise science-based processes to eliminate or inactivate TSE-infectious agents.
By complying with the Essential Requirements of the EU’s MDD and other regulations that apply to medical devices, manufacturers can tap into the European marketplace which consists of 500 million consumers. In addition, medical devices bearing the CE Mark may achieve faster regulatory review and approval in other global markets.
TÜV SÜD is the world’s largest EU Notified Body for AIMDs and other medical devices. Our extensive network makes TÜV SÜD an effective single source for manufacturers seeking expertise in the testing and certification of AIMDs and other medical devices to EU requirements, as well as regulations applicable to these devices in the U.S., Japan and other major markets.