As jz365 has mentioned, the EU has a different regulatory body than the US. For the EU, no design controls are not “needed”. Yet, that will limit your market size because it is needed in the US. I would recommend adhering to whichever regulatory body is more strict because it can help ensure you have a safer product for the masses, and it will allow you to sell to different markets in the future if you want (assuming the all the documents of the less strict are required by the stricter regulatory body).