Regulatory perspective on ATMPs: device combinations

The medicinal product and medical devices fields in Europe are subject to different legislations that were historically seen as largely independent from each other. Innovative drug-device combinations challenge this view and demand stronger interfaces between these two fields. The new Medical Device Regulation provides a new framework for drug–device combinations, but with necessary guidance under development, significant uncertainty remains. Additional questions arise when two innovative fields intersect, as in the case of advanced therapy medicinal product (ATMP) combinations with medical devices. With rapidly progressing scientific knowledge and potentially groundbreaking new therapeutic approaches, it is vital to provide a clear regulatory path for developers to facilitate the development of the new safe and efficacious medicinal products for patients in need.

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