Please provide the document number and location of the 2. Clinical Evaluation Report (CER) - 3. Does the supporting documentation submitted to NSAI include: Literature search protocol Full text of articles referenced in the CER. If not please explain: Does the CER comply with MedDev 2.7.1 Yes No 4. Version of MedDev used: 5. a. Does the CER address the relevant risks of predicate Yes No device If “No” please justify - b. Does the CER address Post market surveillance and or Yes No PMCF ie. Registry or study (reference MED DEV 2.12 /2 ) c. How often is the CER updated with data from the post market surveillance (reference Annex X 93/42/EEC How often is the CER updated? Please provide justification for the frequency of update Please identify the individual(s) who performed the clinical evaluation - 6. Is their CV included? Yes No Is a declaration of interest of the evaluators included Yes No If “No” please justify - Please provide justification of the choice of evaluator(s) 7. Was a clinical investigation completed to demonstrate the Yes No 8. safety and performance of the device
2. Please provide the document number and location of the Clinical Evaluation Report (CER) - 3. Does the supporting documentation submitted to NSAI include: Literature search protocol Full text of articles referenced in the CER. If not please explain: 4. Does the CER comply with MedDev 2.7.1 Yes No Version of MedDev used: 5. a. Does the CER address the relevant risks of predicate device Yes No If “No” please justify - b. Does the CER address Post market surveillance and or PMCF ie. Registry or study (reference MED DEV 2.12 /2 ) Yes No c. How often is the CER updated with data from the post market surveillance (reference Annex X 93/42/EEC How often is the CER updated? Please provide justification for the frequency of update 6. Please identify the individual(s) who performed the clinical evaluation - Is their CV included? Yes No Is a declaration of interest of the evaluators included Yes No If “No” please justify - 7. Please provide justification of the choice of evaluator(s) 8. Was a clinical investigation completed to demonstrate the safety and performance of the device Yes No
GRF-25-45a.docx