医疗器械警戒系统指南-MEDDEV-2.12-1-REV.8-January-2013.pdfVIP

MEDDEV 2 12-1 rev. 8 Vigilance EUROPEAN COMMISSION DG Health and Consumers (SANCO) Directorate B-Consumer Affairs Unit B2- Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDDEV 2.12-1 rev 8 January 2013 GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM The present guidelines are part