EU and US clinical investigation adverse event reporting.
Revised international standards on clinical investigations were recently published. ISO 14155 consists of two parts under the general title Clinical Investigation of Medical Devices for Human Subjects. This article outlines the requirements of the revised standard and contrasts these with United States reporting requirements.
Crowley
Gordon
G
MedNova Ltd, Galway, Ireland. gcrowley@mednova.ie
D002986:Clinical Trials as Topic / Q000592:standards*; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards*; D004282:Documentation / Q000379:methods / Q000592:standards; D004868:Equipment Failure; D004864:Equipment and Supplies / Q000009:adverse effects* / Q000592:standards*; D005060:Europe; D038622:Internationality; D019221:Mandatory Reporting; D011358:Product Surveillance, Postmarketing / Q000379:methods / Q000592:standards*; D014481:United States