title: Notifying the competent authorities.
abstract: The Medical Device Directive requires manufacturers or persons designated by them to provide Competent Authorities with certain types of information on some categories of medical devices. However, this requirement is often misinterpreted and there are some national variations related to the notification of Competent Authorities. This article will discuss Article 14 of the Directive, some frequent misinterpretations and, briefly, Germany's notification requirements.
authors.affiliation: Donawa and Associates Ltd, Rome, Italy. donawa@srd.it
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D004864:Equipment and Supplies / Q000592:standards*; D005060:Europe; D006076:Government; D019983:Guideline Adherence; D006801:Humans; D007255:Information Services; D011358:Product Surveillance, Postmarketing