When gene or cell therapies are incorporated as an integral part of a medical device (MD), they will be regulated as medical devices if they are based on non-viable cells and tissues, the action of which is ancillary to that of the medical device. If the cells and tissues are of animal origin, the MD is regulated by Regulation (EU) 722/2012: the product is a MD containing substances of animal origin.
If the cells and tissues are of human origin, the MD is regulated by Regulation (EU) 2017/745: the product is a MD containing substances of human origin.
In addition, EU law provide specific rules for In Vitro Medical Devicess (IVMD) in Regulation (EU) 2017/746.