Directive 90/385/EEC of the European Union (EU) specifies the Essential Requirements manufacturers and importers must meet to apply the CE Mark and legally market or sell AIMDs in the EU. To demonstrate compliance with the requirements of the AIMD Directive, a manufacturer must develop technical documentation in order to properly evaluate their device. AIMD manufacturers must also establish a quality management system that complies with the Directive’s requirements.
AIMDs marketed or sold in the EU are also subject to other requirements and regulations, including EU Regulation 722/2012 regarding the use of materials of animal origin. This regulation requires manufacturers to utilize science-based processes to eliminate or inactivate TSE-infectious agents, and also requires post-production monitoring and data collection to identify and address possible safety issues.
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.
By achieving compliance with the Essential Requirements of the AIMD Directive, manufacturers may tap into the European market consisting of 500 million consumers. In addition, AIMDs bearing the CE Mark may achieve faster regulatory review and approval in other global markets.