Section 4: Previous Existing Legislation Does the device have any existing approvals (e.g. FDA 1. Yes No 510(k)) 2. If “Yes” – please advise Does this product, labelled with your Name & Address carry Yes No CE Marking with another Notified Body 3. If “Yes” – this is considered a TRANSFER Please refer to applications checklist If you are not the maker of the device does this identical Yes No product carry CE marking by the maker If “Yes” – Please supply a copy of the contract between your company (Own Brand and the actual maker (Original Equipment Manufacturer-OEM) Detailing responsibilities for: Design Changes. Vigilance Issues and complaint Handling. 4. Changes to the OEM Quality Management system and communications about such changes. Changes to the OEM manufacturing environment and communications about such changes. Section 5: Labelling and IFU Location of the sample Label(s) & IFU in the supporting documentation 1. Please include all levels of labelling – device, packaging, carton, etc. Note - Draft labelling is acceptable for New Applications Are copies of all labelling provided? Yes No If No please rationalize that the sample provided is representative of the family 2.
Section 4: Previous Existing Legislation 1. Does the device have any existing approvals (e.g. FDA 510(k)) Yes No 2. If “Yes” – please advise 3. Does this product, labelled with your Name & Address carry CE Marking with another Notified Body Yes No If “Yes” – this is considered a TRANSFER Please refer to applications checklist 4. If you are not the maker of the device does this identical product carry CE marking by the maker Yes No If “Yes” – Please supply a copy of the contract between your company (Own Brand and the actual maker (Original Equipment Manufacturer-OEM) Detailing responsibilities for: Design Changes. Vigilance Issues and complaint Handling. Changes to the OEM Quality Management system and communications about such changes. Changes to the OEM manufacturing environment and communications about such changes. Section 5: Labelling and IFU 1. Location of the sample Label(s) & IFU in the supporting documentation Please include all levels of labelling – device, packaging, carton, etc. Note - Draft labelling is acceptable for New Applications 2. Are copies of all labelling provided? Yes No If No please rationalize that the sample provided is representative of the family
GRF-25-51.docx