As an AIMD manufacturer, you must ensure that your product meets the relevant regulatory requirements before being placed to the market.
According to the MDR an Active Implantable Medical Device is:
Its functioning depends on an energy source other than that generated by the human body for that purpose or by gravity, and which acts by changing the density of or converting that energy.
It is to be totally introduced into the human body or used to replace an epithelial surface or the surface of the eye by clinical intervention and is intended to remain in place after the procedure.
It is intended to be partially introduced into the human body by clinical intervention and to remain in place after the procedure for at least 30 days.
AIMDs are subject to rigorous regulatory controls both pre- and post-market. The regulatory controls set out in the MDR also apply to any accessories that are used to enable the device to operate as intended, such as, battery packs, controllers, implant kits, leads, programmers, refill kits, and software applications.
Active Implantable Medical Devices and their accessories are classified as Class III and therefore subject to the most rigorous regulatory controls.
