Module 18 - Drug Device Combinations and Other Technologies

30/11/2023

Medical Device regulations .. Impact for combination products

• New guidances under development / to be finalised • NB assessment of delivery devices • Without the need for CE marking

• Emerging new guidances on QUALITY aspects for drug-device combination products.

• Both US and EU • Need for improvement in regulatory assessments… driven by the MDRs in the EU

The Organisation for Professionals in Regulatory Affairs

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