Y
Y-Spi
Hello Colleagues ,
Does anyone know what clinical data is required for submission of a drug delivery system, to obtain a CE mark (see explanation below)?
Can the intended use be general, and not clinical (e.g., the device is intended for delivery of medicinal substances via..."?
We developed a drug delivery system that was tested (in-vitro as well as clinically) with only one drug. The device is not pre-filled but can be used only with pre-filled cassettes. Currently the cassettes contain only one drug, but we intend to produce cassettes with other drugs in the future. The device in intended for re-use.
Many thanks!
Y
Does anyone know what clinical data is required for submission of a drug delivery system, to obtain a CE mark (see explanation below)?
Can the intended use be general, and not clinical (e.g., the device is intended for delivery of medicinal substances via..."?
We developed a drug delivery system that was tested (in-vitro as well as clinically) with only one drug. The device is not pre-filled but can be used only with pre-filled cassettes. Currently the cassettes contain only one drug, but we intend to produce cassettes with other drugs in the future. The device in intended for re-use.
Many thanks!
Y