title: Great regulatory expectations.
abstract: In a remarkably short time, the European regulatory landscape for medical devices has changed dramatically and permanently. The speed of this change will continue to accelerate until a fully matured body of rules is in place. This article will examine the current status of regulations in Europe, and some areas that will need to be addressed in the next century.
authors.affiliation: Donawa and Associates Ltd, Rome, Italy. donawa@srd.it www.donawa.com
authors.forename: M
authors.initials: M
authors.lastname: Donawa
mesh_terms: D004867:Equipment Design / Q000592:standards*; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D005544:Forecasting; D006801:Humans; D013677:Medical Laboratory Science / Q000331:legislation & jurisprudence / Q000592:standards*; D011050:Policy Making; D011640:Public Policy