MDD 医疗器械分类指南.pdfVIP

EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES: Guidance document MEDDEV 2.4/1 Rev.8 July 2001 GUIDELINES FOR THE CLASSIFICATION OF MEDICAL DEVICES The present Guidelines are part of a set of Guidelines relating to questions of application of EC- Directives