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.
The intention of the Directive is to provide a harmonised regulatory environment to allow Active Implantable Medical Devices (AIMDs) to be sold throughout the European Economic Area without further national regulation.
The Directive applies only to active implantable devices - all non active devices medical devices are (or will be) covered under one of two other Directives - the Medical Devices Directive and the (proposed) In Vitro Diagnostic Devices Directive.
The definition of an active implantable medical device given in the Directive is as follows:
- 'active medical device' means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity;
- '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;
Examples of products within the scope of the Directive include cardiac pacemakers, neural stimulators and implantable infusion pumps and defibrillators and their accessories.
The requirements for devices within the scope of the Directive are essentially the same as for devices classified as class III under the Medical Devices Directive. These include essential safety requirements in terms of function, sterility, material compatibility, marking, 'user' instructions, design documentation and CE marking but also include requirements for type approval, production quality management, clinical investigation and manufacturer registration.
The Medicines and Healthcare products Regulatory Agency also have a useful website including several helpful publications to download.