Module 18 2021

Assessment of combined ATMPs

● Whole product is assessed by EMA as a medicinal product – Demonstration of compatibility of the tissues/cells with the device components of the product ● Medical device component must meet ERs of 93/42/EEC (or 90/385/EEC); evidence of conformity must be provided ● Results of Notified Body assessment of the device shall be included if available ● EMA shall “recognise” the NB assessment ● If no NB assessment has taken place, EMA shall seek opinion of a NB unless the CAT decides that no NB involvement is needed

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TOPRA MSc Module 18: Drug Device Combinations and other Technology