Section 14 – Clinical Performance (Human) 14.1 Clinical Evaluation 3. 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 explain - Please provide justification of the choice of evaluator(s) - Has a clinical investigation been performed to demonstrate the Yes No safety and performance of the device If “No” please explain - 4. 5. For this device : a. Are any further clinical investigations planned Yes No b. Are any further clinical investigations on-going Yes No c. Are any other relevant clinical investigations completed Yes No d. How often is the CER updated with data from the post market surveillance(reference Annex X 93/42/EEC If “Yes” please provide additional information including study identifier and status (note – not limited to EU S&P studies / Investigations, i.e. include reference to Other Geographical Reg Requirements, studies/investigations for reimbursement purposes, etc) 6. For clinical investigations please submit the following: Letter of no objection from Competent Authority(s) (CAs) or other regulatory agency(s) as appropriate Clinical investigation plan and amendments for which no grounds for objection were raised Ethics committee opinion(s) and comments arising from their review Signed and dated final report (signed by the sponsor, the co-ordinating clinical investigator – if appointed – and principal investigator at each site).
Section 14 – Clinical Performance (Human) 14.1 Clinical Evaluation 3. 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 explain - Please provide justification of the choice of evaluator(s) - 4. Has a clinical investigation been performed to demonstrate the safety and performance of the device Yes No If “No” please explain - 5. For this device : a. Are any further clinical investigations planned Yes No b. Are any further clinical investigations on-going Yes No c. Are any other relevant clinical investigations completed Yes No d. How often is the CER updated with data from the post market surveillance(reference Annex X 93/42/EEC If “Yes” please provide additional information including study identifier and status (note – not limited to EU S&P studies / Investigations, i.e. include reference to Other Geographical Reg Requirements, studies/investigations for reimbursement purposes, etc) 6. For clinical investigations please submit the following: Letter of no objection from Competent Authority(s) (CAs) or other regulatory agency(s) as appropriate Clinical investigation plan and amendments for which no grounds for objection were raised Ethics committee opinion(s) and comments arising from their review Signed and dated final report (signed by the sponsor, the co-ordinating clinical investigator – if appointed – and principal investigator at each site).
GRF-25-44a.docx