Regulation of medical devices in the European Union.
Chai
J
J
Northwestern University Dental School, 240 East Huron Street, Chicago, Illinois, 60611, USA. jchai@nwu.edu
D002986:Clinical Trials as Topic; D003132:Commerce / Q000331:legislation & jurisprudence; D018795:Device Approval / Q000331:legislation & jurisprudence* / Q000592:standards; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000145:classification / Q000592:standards; D005062:European Union / Q000191:economics / Q000458:organization & administration*; D006801:Humans; D007221:Industry / Q000331:legislation & jurisprudence / Q000592:standards; D017149:Private Sector / Q000458:organization & administration; D019736:Prostheses and Implants / Q000592:standards; D011786:Quality Control; D018570:Risk Assessment