Module 3 Presentations

07/05/2024

How to demonstrate compliance with the General safety & performance requirements in the Drug dossier? • Primarily a technical documentation is required to demonstrate the compliance during as part of the Notified Body Opinion Procedure • However, additional information about the device part is not required: Specifics on Drug-Device combinations

The Organisation for Professionals in Regulatory Affairs

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In a nutshell: Specifics on Drug-Device combinations

Summary • Certain primary packaging “components” are considered to be a device in Europe if they are “ a device that is intended to administer a medicinal product in the case where the device and the medicinal product form a single integral product, which is intended exclusively for use in the given combination and which is not reusable.” (e.g. pre-filled syringes) • Those components are regulated under the Medicinal Product Directive (2001/83/EC), however in addition some requirements of the Medical Device Directive (93/42/EEC) need to be fulfilled

The Organisation for Professionals in Regulatory Affairs

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