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/S002013832...