Module 3 2019

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