Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Data for medical devices in combined ATMPs device information

Device Information 3.2.R

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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Practical issues with assessment of combined ATMPs

● NB is required to make assessment available to the Competent Authority – but not the ATMP manufacturer ● NB assessment of original device may not have been necessary (Class I, IIa, IIb devices) ● NB assessment may not have included – Compatibility with relevant cell types – Implantation site/location – Degradation in relevant site – Processing conditions for cell culture and storage ● so assessment is not complete for this use – additional data must be provided and assessed – important to get classification correct as drives data requirements

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TOPRA MSc Module 18: Drug Device Combinations and other Technology

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