title: French homologation for medical devices: past and future.
abstract: The French approval procedure for medical devices, known as homologation, is considered to be one of the most complicated national approval processes in Europe.  This article outlines some of the key elements of homologation and the major changes that have been introduced since 1991.  In addition, homologation will not survive in its present form when the EC Directives come into force.  The author outlines current expectations.
authors.affiliation: TUV Product Service, München, FRG.
authors.forename: J
authors.initials: J
authors.lastname: Rader
mesh_terms: D002986:Clinical Trials as Topic; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D005544:Forecasting; D005602:France; D006801:Humans; D007349:Insurance, Health, Reimbursement; D007883:Legislation, Medical; D011785:Quality Assurance, Health Care / Q000331:legislation & jurisprudence / Q000639:trends