Module 18 - Drug Device Combinations and Other Technologies

04/12/2023

Device and medicinal product contents are marketed as a single, inseparable unit: unit

Combined ATMP Regulation 1394/2007 Article 2.1(d)

is regulated as a medicinal product

An ATMP that fulfils the following conditions: ● it must incorporate, as an integral part of the product, one or more medical devices within the meaning of Article 1(2)(a) of Directive 93/42/EEC or one or more active implantable medical devices within the meaning of Article 1(2)(c) of Directive 90/385/EEC, and

● its cellular or tissue part must contain viable cells tissues, or ● its cellular or tissue part containing non-viable cells must be liable to act upon the human body with action that can be considered as primary to that of the device

ie the cells/tissues are the active substance

19

TOPRA MSc Module 18: Drug Device Combinations and other Technology

19

Care needed in definition

● Cells/tissue and device must be integral ● Non-cellular component must meet device definition on its own ● Cell/tissue component must provide primary MOA – Default if cells are viable (Article 2.2) – If cells are non-viable, scientific evidence of primary contribution to MOA ● ATMP component may be TEP, SCT or GT ● Reflection paper on classification of advanced therapy medicinal products (EMA/CAT/600280/2010 rev.1)

– Discusses distinction between the four classifications of ATMP – In cases where still unclear, use classification procedure – EMA 60 day process – Committee on Advanced Therapies (CAT) recommendation

20

TOPRA MSc Module 18: Drug Device Combinations and other Technology

20

10