Ad-hoc support
•Clinical Study Protocol (CSP) or Clinical Investigation Plan (CIP
•Investigator’s Brochure (IB)
•Patient Information and Informed Consent Form (ICF)
•Clinical Evaluation
•Clinical Study Report (CSR) or Clinical Investigation Report (CIR)
•Clinical Overview and Summary
•Literature search
•Non-interventional Study Protocol
•Protocol for Post-marketing Safety and/or Efficacy Study
•Post-marketing Clinical Follow-up (PMCF) Plan
•Update of your Clinical Evaluation
•Posters and Scientific Article