The following information is a summary of the requirements of the Directive. It is not an area in which we currently offer advice but you may find some useful information and links here.
This directive applies only to active implantable devices. To be classed as such a device must rely on a power source not provided by the body or gravity and be designed to be introduced into the body with the intention to remain there following the procedure. The Directive specifies that these products should meet essential safety requirements in terms of function, sterility, material compatibility, marking, user instructions and design documentation. In addition there are requirements for type approval, production quality management, clinical investigation and manufacturer registration. The Directive came into force in 1993 and all equipment within the scope must comply.
Amendments to the Active Implantable Medical Devices directive (2007/47/EC) came into force on 21 March 2010.