警戒系统表单.pdf

MEDDEV 2 12-1 rev. 8 Vigilance 10.3 ANNEX 3 - REPORT FORM FOR MANUFACTURER’S TO THE NATIONAL COMPETENT AUTHORITY v.01.13 Report Form Manufacturer’s Incident Report Medical Devices Vigilance System (MEDDEV 2.12/1 rev 8) 1. Administrative information Recipient Stamp box for the Competent Name of National Competent Authority (NCA) Authority (~ 60 x 40 mm) Address of National Competent Authority Date of this report Reference number assigned by the manufacturer Reference number assigned by NCA Type of report Initial report Follow-up report Combined Initial and final report Final report Does the incident represent a serious public health threat? Yes No Classification of incident Death Unanticipated serious deterioration in state of health All other reportable incidents Identify to what other NCAs this report was also sent 2. Information on submitter of the report Status of submitter Manufacturer Authorised Representative within EEA, Switzerland and Turkey Others: (identify the role) : 40 MEDDEV 2 12-1 rev. 8 Vigilance 3. Manufacturer information Name Contact name Address Postcode City Phone Fax E-mail