The Active Implantable Medical Devices Directive

Summary

The ATEX Directive is a CE marking Directive that 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.

Contents

Purpose
Scope
Requirements
Application date
Further advice

Purpose

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.

Scope

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 In Vitro Diagnostic Medical 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.

Requirements

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.

Application date

The Directive was brought into force with effect from 1 January 1993. Transitional arrangements permitted equipment which complied with national regulations to be sold until 31 December 1994 but the AIMD directive is now fully in force and all equipment within the scope must comply.

Further advice

For further advice please contact us at Conformance where we will be pleased to discuss your needs.

The UK Medical Devices Agency also have a very useful website including lots of helpful publications to download.