AIMDs are typically high risk devices and are subject to rigorous standards and definitions before they can reach global markets. Directive 90/385/EEC regulates the market readiness and service parameters for active implantable medical devices (AIMDs). In order to meet regulations under 90/385/EEC, a product must meet the directive’s definition of an AIMD: a medical device that is – at the same time – both “active” and “implantable”.
Quote from the directive “Active implantable medical device" means 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.”
This definition may apply to an entire system or to interchangeable parts intended to form a system (together along with other devices). In these cases, each part belonging to a system is covered under the Directive – regardless of whether such part on its own is 'active', 'active and implantable' or not.
Examples of AIMDs include: