If no update to Risk Management File, please provide rationale: 4. Section 9: Sterilisation & STABILITY 9.1 Sterilisation Validation For devices provided sterile 1. Yes No Does the proposed change affect sterilisation If “No” please justify - 2. Yes No Is a full validation/revalidation required If a full validation/revalidation not completed, please provide an Adoption justification/rationale report 3.
4. If no update to Risk Management File, please provide rationale: Section 9: Sterilisation & STABILITY 9.1 Sterilisation Validation For devices provided sterile 1. Does the proposed change affect sterilisation Yes No If “No” please justify - 2. Is a full validation/revalidation required Yes No 3. If a full validation/revalidation not completed, please provide an Adoption justification/rationale report
GRF-25-43a.docx