According to the Medical Device Regulation state, it is essential to designate an authorized representative in order to sell the product within Europe.
If you aren't,
- I am assuming you're Notified Body will not issue your EC Certificate which is kind of a legal requirement to market this medical product.
- If you continue to ship your goods to Europe I'm betting that someone will block it at the point of entry.
What is the significance of this?
There is no Marketing Authorization granted by Competent Authorities for your product.
All of this is put designed to safeguard the patients from fake products and reduce the chance of suffering the injury.
So the conclusion is that it is compulsory to appoint an EC rep to sell your products in Europe.