title: Spain's competent authority initiatives.
abstract: In Spain, only the Active Implantable Medical Device Directive has been transposed into national legislation, with the Medical Device Directive relevant Decree still in a draft edition. However, the notification of serious adverse incidents is compulsory for manufacturers and users, both for CE-marked devices and non CE-marked devices. Manufacturers of all medical devices classes must be registered at the national competent authority, though the directives do not require it.
authors.affiliation: Spanish Ministry of Health, Madrid, Spain.
authors.forename: C A
authors.initials: CA
authors.lastname: Luna
mesh_terms: D004864:Equipment and Supplies / Q000592:standards; D017408:Guidelines as Topic; D007883:Legislation, Medical; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards; D013030:Spain