title: How are medical devices regulated in the European Union?
authors.affiliation: Guildford Medical Device Evaluation Centre (GMEC), The Royal Surrey County Hospital, Egerton Road, Guildford, Surrey GU2 7XX, UK. elainefrench-mowat@btconnect.com
authors.forename: Elaine
authors.initials: E
authors.lastname: French-Mowat
authors.forename: Joanne
authors.initials: J
authors.lastname: Burnett
mesh_terms: D003406:Credentialing / Q000331:legislation & jurisprudence / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004869:Equipment Safety / Q000145:classification / Q000592:standards; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D005062:European Union; D033161:Government Regulation; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence* / Q000592:standards*; D007391:International Cooperation / Q000331:legislation & jurisprudence*; D007883:Legislation, Medical / Q000458:organization & administration; D011358:Product Surveillance, Postmarketing / Q000592:standards; D012015:Reference Standards