What is the result of not appointing an Authorized Representative?

Authorized Representative' means any natural or legal person based in the Union who has been given an authorized written order from the manufacturer located outside the Union acting on behalf of the manufacturer in regards to specific tasks with regards to the manufacturer's ob

According to the Medical Device Regulation state, you must choose an Authorized Representative in order to sell the product within Europe.

If you aren't,

  • I presume the Notified Body will not issue your EC Certificate which is kind of a legal requirement to market the medical devices you have purchased.
  • If you try to deliver your products to Europe I am sure that someone will block it at the border.

Why is this important?

Since there isn't an Advertising Authorization given by Competent Authorities for your product.

This is all being put in place to guard the public against counterfeit products and reduce the chance of suffering the injury.

So the conclusion is that you have to must appoint the EC representative to sell your products in Europe.


I3C GLOBAL

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