When gene or cell therapies are incorporated as an integral part of a medical device (MD), they should be regulated as medical devices.
This is relevant for:
- non-viable tissues and cells of animal origin: the MD is regulated by Regulation (EU) 722/2012.
- non-viable tissues and cells of human origin, the action of which is ancillary to that of the medical device: the MD is regulated by Regulation (EU) 2017/745.