title: National handling of medical devices vigilance reports and the use of registers.
abstract: A compulsory incident reporting is operating in Norway, as part of the implementation of the medical devices directives (MDD). Incidents are being handled locally by the quality councils and only if they prove of importance they are entered into the central database. As for the MDD Vigilance, exchange of information concerning investigation and follow up of incidents is forming a different part of the reporting system. The different possibilities of use of registers, in Norway and accordingly in the European Union, is analysed further in this paper.
authors.affiliation: Norwegian Board of Health, Oslo, Norway.
authors.forename: J
authors.initials: J
authors.lastname: Nordan
mesh_terms: D003764:Dental Materials; D004864:Equipment and Supplies; D005062:European Union; D007595:Joint Prosthesis; D009664:Norway; D011358:Product Surveillance, Postmarketing / Q000379:methods; D012042:Registries