欧盟医疗器械指令 警戒系统 MEDDEV-2-12-1-REV-6 WORD版.docxVIP

1EUROPEAN COMMISSIONDG ENTERPRISE AND INDUSTRYDirectorate F-Consumer GoodUnit F3- Cosmetic and Medical DevicesMEDICAL DEVICES: Guidance documentMEDDEV 2.12-1 rev 6December 2009GUIDELINESON A MEDICAL DEVICES VIGILANCE SYSTEMThe present guidelines are part of a set of guidelines relating to questions