Dear Community
Is it correct that:
> All components/accessories within an IVD (98/79/EC) Kit require CE mark in their own right?
> and that as soon as the OEM device (component) is re-labelled, the re-labeller/packer then take responsibility of the product and becomes the legal manufacturer
> does this then mean that the re-labeller/packer needs to develop separate Technical Files for each device and/or have in place a written agreement with the OEM for access to TF
> and that the re-labeller must assign a UDI to each component
> finally, is possible that while the final assembled system will contain individual CE marked devices, the assembled kit itself will not need to carry the CE
Thank you for your input
Is it correct that:
> All components/accessories within an IVD (98/79/EC) Kit require CE mark in their own right?
> and that as soon as the OEM device (component) is re-labelled, the re-labeller/packer then take responsibility of the product and becomes the legal manufacturer
> does this then mean that the re-labeller/packer needs to develop separate Technical Files for each device and/or have in place a written agreement with the OEM for access to TF
> and that the re-labeller must assign a UDI to each component
> finally, is possible that while the final assembled system will contain individual CE marked devices, the assembled kit itself will not need to carry the CE
Thank you for your input