Module 18 2021

08/02/2021

Multifaceted Example

Points for consideration A change affecting one part of the Drug-Device combination, may impact on the other …therefore the wider implications of any change should always be considered

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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

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