The Active Implantable Medical Device (AIMD) Directive 90/385/EEC defines an active implantable medical device as "any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure". As one of the highest risk categories of device, they are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the AIMD Directive also apply to any accessories that are used to enable the device to operate as intended, for examples leads, programmers, controllers, battery packs, software applications, implant kits and refill kits.
As a full scope Notified Body, BSI offers CE certification services to the AIMD Directive. Our AIMD team has a broad range of industry and regulatory experience, including product design and development, manufacture and regulatory expertise. The AIMD team also has specific expertise in radio telecommunications (R&TTE) and software development.