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This document provides requirements and guidelines on the development of drug delivery systems intended for self-administration of medicinal products by the specific demographic group of paediatric patients who are performing some or all use steps required for their intended use.
Use steps include any handling action performed after the patient has received the product; these can include but are not limited to:
This document is applicable to injectable drug delivery systems for administration of medicinal products. Furthermore, this document can be useful for the development of other drug delivery devices or systems if they are intended for use by the paediatric population.
Devices not in the scope of this document include catheters, for example those in the scope of ISO 10555 series, and infusion pump systems, e.g. IEC 60601-2-24 and aerosol delivery devices (ISO 20072).
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