Tag Archives: importing into the eu

Last updated: November 7, 2025

New EU MDR: Who Are The “Economic Operators” For Imported Devices?

Since May 2021, the New EU MDR Medical Device Regulation 2017/745 is in place. One of its objectives has been improving the safety of users and patients. And one way to achieve that objective is ensuring that all the parties involved … Continue reading

Posted in EU MDR | Tagged , , , , , , | Leave a comment

EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?

If you make, import, or distribute products that end up on the European Union market, and if your products may be categorised as medical, you need to be very clear about that. As we discussed recently, the companies involved in … Continue reading

Posted in EU MDR | Tagged , , , , , , | Leave a comment