Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Public

Examples of Medicinal products with single integral delivery device (Drug-Device Combination)

• Prefilled syringes/pens • Pre-charged nebulizers • Patches for transdermal drug delivery • Aerosols containing a medicinal substance • Implants that release a medicinal product

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Background to Article 117

Concerns with the gap in legislation of such products: • Technological advancements in the device area • Not explicitly stated what data was required for the device • MDD states the device must meet applicable ERs as per Annex I of MDD but this wasn’t stated in 2001/83/EEC • Competent Authority expectations for the device component were not clearly defined & divergence in approaches

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