Australas Phys Eng S
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The new European system for the regulation of medical devices is currently being introduced incrementally, having begun in 1993 with a view to completion around the turn of the century. Although still it its relative infancy there has already been valuable experience gained in relation to certain device types. The system is based upon three EC Directives; the first covering active implantable devices is now fully in force; with the second covering most other devices, currently within a transition phase. ⋯ Ongoing improvements to the Guidelines appear to be the best way to try to "level the playing field" across the EEA. Considerable effort continues to be made to fine tune this document with input representing regulatory and industry interests and it is hoped that a second revision may be available next year. Vigilance is gaining popularity as a model for adoption outside the EEA, particularly as it begins to overcome the operational hurdles characteristic of the first "live running" of any new system.