Transcription of (MEDDEV 2.12/1 rev 8) v.01.13 1. Administrative Information
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(MEDDEV 2.12/1 rev 8) v.01.13 1. Administrative Information
field safety corrective action report form Medical Devices Vigilance System (MEDDEV rev 8) Page 1 of 5 1. Administrative Information Destination Ministry of Health Vigilance on Medical Devices Via Giorgio Ribotta 5, IT - 00144 Roma Italy Type of report Initial report Follow up report Final report Date of this report 30 October 2015 Reference Number Assigned by Manufacturer 21833502-01/19/2015-001-R FSCA Reference Number Assigned by NCA 2015/001/029/071/001 Incidence Reference Number Assigned by NCA N/A Name of the Coordinating National Competent Authority (if applicable) MHRA 2. Information on Submitter of the report Status of submitter Manufacturer Authorised Representative within EEA, Switzerland and Turkey Others: (identify the role): Smiths Medical Risk Management Specialist on Manufacturer s Behalf 3.
Field Safety Corrective Action Report Form Medical Devices Vigilance System (MEDDEV 2.12/1 rev 8) v.01.13 Page 5 of 5 Submission of this report does not, in itself, represent a conclusion by the manufacturer and / or
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