It must be some kind of EU approval or how would you explain
> Following the regulatory approval, Innie’s birth control is now available for purchase in Germany and Austria, with plans to expand to the UK later this year
I think that just the fact that you can buy it does not make it a medical device.
You can buy contraceptive devices such as a larger con you press between your knees (just kidding) but they would not be medically approved as contraceptives.