How to register ATMP-Device combination products?

Medical Device made Easy Podcast · Sep 28, 2020

ATMP stands for Advanced Therapy Medicinal Products, which is a category of Medicinal Product. But if I combine this with a Medical Device, how should this be regulated and how can I register this product in Europe?

Effectively, this is exactly the question that Margareth Jorvid from Methra Uppsala AB will help us to answer. So if your product is combined with a Medical Device, you should listen to that.

Remember, we had a previous episode specifically on combined products Drug-Device but here you’ll see that the process is a bit different.

To help you understand, we will review the…