Section 2: NATURE OF THE CHANGE 1. Please provide a clear, detailed description of the change(s): Did the change(s) arise from a vigilance or performance Yes No 2. issue If “Yes” – please advice Has NSAI received the Vigilance Report(s) Yes No 3. If “Yes” please provide the relevant Unique Identifier number(s) – If “No” please: a. Justify b. If applicable, please submit a copy of the Competent Authority report(s) along with the completed NSAI Vigilance Form located at [ -“Vigilance Reporting”] to Has this product been the subject of product recalls or Incident Reports in other Regulatory 4. geographies outside EU? If yes, please summarize and provide details with supporting documentation. For those failure modes associated with the identified Root Causes, please clarify if the Occurrence Rates outlined in the Risk Management File required an update based on the 5 observed real world rates.
Section 2: NATURE OF THE CHANGE 1. Please provide a clear, detailed description of the change(s): 2. Did the change(s) arise from a vigilance or performance issue Yes No If “Yes” – please advice 3. Has NSAI received the Vigilance Report(s) Yes No If “Yes” please provide the relevant Unique Identifier number(s) – If “No” please: a. Justify b. If applicable, please submit a copy of the Competent Authority report(s) along with the completed NSAI Vigilance Form located at [ -“Vigilance Reporting”] to 4. Has this product been the subject of product recalls or Incident Reports in other Regulatory geographies outside EU? If yes, please summarize and provide details with supporting documentation. 5 For those failure modes associated with the identified Root Causes, please clarify if the Occurrence Rates outlined in the Risk Management File required an update based on the observed real world rates.