Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Acknowledgment: Philips Medisize Corporation

The Organisation for Professionals in Regulatory Affairs

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EU Drug-device combinations

• Drug Product – primary action • EMA / national CA reviews the dossier • Typically administration devices only

• Separate administration devices must be CE marked • If integrated administration devices (not separate) must meet GSPR. Do not need CE mark but do need NB opinion • Additional information needed • Compatibility, functionality, safety / tox

The Organisation for Professionals in Regulatory Affairs

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