title: European medical device regulation: a new era?
abstract: By the spring of 2005, the European Commission hopes to present the first draft of the revisions to the Medical Device Directive to the European Council and Parliament. However, these revisions represent only part of the changing European regulatory scenario. This article discusses a tangible shift in European medical device regulatory policy and some actions that companies can take to understand and prepare for these policies.
authors.affiliation: Donawa & Associates Ltd, Rome, Italy. medonawa@donawa.com
authors.forename: Maria
authors.initials: M
authors.lastname: Donawa
mesh_terms: D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards*; D004864:Equipment and Supplies / Q000592:standards*; D005062:European Union; D033161:Government Regulation; D019983:Guideline Adherence; D017408:Guidelines as Topic; D011358:Product Surveillance, Postmarketing / Q000592:standards* / Q000639:trends