Hi All,
I'm enquiring about the supply of IFU's for Procedure packs.
Assuming a company assembles a procedure pack comprising of individual components manufactured themselves and Medical devices by other Manufacturers and the 'other company' states that their product requires an IFU for its safe use. The Pack manufacturer is required to supply the IFU at the same rate as recommedned by the OEM.
I have seen this in the field, however if there are many components all requiring IFUs there could potentially be a selection of 10-20 IFU's per pack - This I have never seen by any Pack manufacturer.
My question is - How do pack manufacturers get around not supplying IFU's? I'm aware of numerous occasions where a device requires one, but it is not available either in the pack or in the supply carton. Are Pack manufacturers doing thier own risk assessment that is stating that an IFU is not required, irresepective of the OEM information?
Please assume that the Pack is CE marked by its own accord and not assembled in accordance with Article 12.
I look forward to peoples thoughts
I'm enquiring about the supply of IFU's for Procedure packs.
Assuming a company assembles a procedure pack comprising of individual components manufactured themselves and Medical devices by other Manufacturers and the 'other company' states that their product requires an IFU for its safe use. The Pack manufacturer is required to supply the IFU at the same rate as recommedned by the OEM.
I have seen this in the field, however if there are many components all requiring IFUs there could potentially be a selection of 10-20 IFU's per pack - This I have never seen by any Pack manufacturer.
My question is - How do pack manufacturers get around not supplying IFU's? I'm aware of numerous occasions where a device requires one, but it is not available either in the pack or in the supply carton. Are Pack manufacturers doing thier own risk assessment that is stating that an IFU is not required, irresepective of the OEM information?
Please assume that the Pack is CE marked by its own accord and not assembled in accordance with Article 12.
I look forward to peoples thoughts