What Clinical Data is required for Drug Delivery System

Y

Y-Spi

#1
Hello Colleagues :bigwave:,

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
 
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shimonv

Trusted Information Resource
#2
Does anyone know what clinical data is required for submission of a drug delivery system, to obtain a CE mark (see explanation below)?
I suggest you start by looking at the MEDDEV guidances on clinical evaluation and clinical investigation Guidance - European Commission

Can the intended use be general, and not clinical (e.g., the device is intended for delivery of medicinal substances via..."?
It really depends in the specifics of your device... but I am doubtful when it comes to a drug delivery system.
Start with the clinical evaluation / investigation part and it will become clearer to you.

Shimon
 
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