Medical devices containing tissues and cells 

When gene and cell therapies are based on tissues and cells which are incorporated as an integral part of a medical device (MD), they may be regulated as medical devices. Such a classification gives rise to a number of specific rules under the applicable legislative frameworks. This is relevant for: 

• Medical devices containing human cells or tissues/SoHO
• Medical devices containing animal cells or tissues

These frameworks include specific requirements notably among the obligations applicable to manufacturers of such device:

• Obligations applicable to medical device manufacturers