Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

CAT Classification Decisions

Product

Indication Bone defects

Classification TEP, combined

adipose tissue-derived mesenchymal stem cells expanded ex vivo combined with biomaterial β TCP Cultured autologous adipose-derived stem cells on a polypropylene tubular scaffold Encapsulated human retinal pigment epithelial cells genetically modified to express human factor IX protein Allogeneic human Wharton’s jelly-derived mesenchymal stem cells seeded onto decellularized dermal scaffold

Radical cystectomy in bladder cancer

TEP, combined

GT, combined Haemophilia B

Epidermolysis bullosa

TEP, not combined

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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 MDR; 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

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