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 3: INTENDED USE OF THE DEVICE 1. Is there a change in Intended Use Yes No Please enter a full description of the revised intended use and/ or indications for use of the device- 2. Does this change impact the classification/rule Yes No 3. If “No” please justify -
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. SECTION 3: INTENDED USE OF THE DEVICE 1. Is there a change in Intended Use Yes No 2. Please enter a full description of the revised intended use and/ or indications for use of the device- 3. Does this change impact the classification/rule Yes No If “No” please justify -
GRF-25-43a.docx