title: Regulatory requirements for medical devices in the European Union.
authors.affiliation: Department of Surgery, University Hospital Utrecht, The Netherlands.
authors.forename: B C
authors.initials: BC
authors.lastname: Eikelboom
authors.forename: P
authors.initials: P
authors.lastname: Duijst
mesh_terms: D000818:Animals; D002986:Clinical Trials as Topic; D004864:Equipment and Supplies / Q000592:standards; D005060:Europe; D005062:European Union; D017408:Guidelines as Topic; D006805:Human Experimentation; D006801:Humans; D007883:Legislation, Medical; D008422:Materials Testing / Q000592:standards; D011785:Quality Assurance, Health Care; D012107:Research Design