title: The IVD directive: planning for compliance.
abstract: In less than 20 months, companies will only be allowed to place in vitro diagnostic (IVD) medical devices on the European market if they bear the CE mark. For this reason, the process of ensuring compliance with CE-marking requirements on or before the end of the transition period, if not already begun, should be initiated immediately. This article discusses important compliance issues.
authors.affiliation: donawa@srd.it
authors.forename: Maria E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D003132:Commerce / Q000592:standards*; D019719:Diagnostic Equipment / Q000145:classification / Q000592:standards*; D005060:Europe; D005062:European Union; D019983:Guideline Adherence; D006801:Humans; D066298:In Vitro Techniques; D010934:Planning Techniques