Guide to the EU Active Implantable Medical Devices Directive

摘要

This guide (prepared under contract by Helen Delaney and Rene van de Zande, DVZJoint Ventures) is an easy-to-use introductory reference for industry and government officials on the requirements of the European Union's (EU) Active Implantable Medical Devices Directive (AIMD) (90/385/EEC). The Active Implantable Medical Devices Directive applies to devices and their accessories. The AIMD covers implantable products such as cardiac pacemakers, defibrillators, infusion pumps, diaphragm stimulators, bladder stimulators, and neurostimulators. In addition, the Directive covers accessories and software such as image-enhancing software intended for diagnostic purposes. 'Active' implies that the function of these devices is dependent upon a source of electrical energy.