SECTION 5: DESIGN AND MANUFACTURING OvERViEW Does this change require an update or new design development documentation – e.g. design and development plan, update to Yes No design input output matrix, product specification: If Yes, please provided copies: 5.1 If No, please justify: Does this change require an update to the manufacturing process Yes No or product specification/release criteria? If Yes, please provide a List of manufacturing processes and validation status & updated Product specification or product release criteria 5.2 If No, please justify: Section 6: Solutions to Essential Requirements and Harmonised Standards Please indicate how relevant Essential Requirements (Annex I) of the Directive are met for the proposed changes. Location of the revised solutions to Essential Requirements in the supporting documentation 1. 2. Please list the relevant Harmonised Standards in Table 2 below Add rows as required.
SECTION 5: DESIGN AND MANUFACTURING OvERViEW 5.1 Does this change require an update or new design development documentation – e.g. design and development plan, update to design input output matrix, product specification: Yes No If Yes, please provided copies: If No, please justify: 5.2 Does this change require an update to the manufacturing process or product specification/release criteria? Yes No If Yes, please provide a List of manufacturing processes and validation status & updated Product specification or product release criteria If No, please justify: Section 6: Solutions to Essential Requirements and Harmonised Standards Please indicate how relevant Essential Requirements (Annex I) of the Directive are met for the proposed changes. 1. Location of the revised solutions to Essential Requirements in the supporting documentation 2. Please list the relevant Harmonised Standards in Table 2 below Add rows as required.
GRF-25-43a.docx