I'm not super familiar with the regulatory landscape in Europe, but I did find this article [1] while I was researching for this project. I believe the EU has

I'm not super familiar with the regulatory landscape in Europe, but I did find this article [1] while I was researching for this project. I believe the EU has a similar pathway (in the EU Medical Device Regulation) for new devices relying on equivalence to a predicate, but the requirements for demonstrating equivalence are a higher bar. Joint prostheses (like the one causing cobalt poisoning in the US) are not allowed through this process in the EU. [1]: https://www.sciencedirect.com/science/article/pii/S0020138323005946 https://www.sciencedirect.com/science/article/pii/S002013832...