The European Authorized Representative for medical devices is assigned a pivotal role in the CE Marking process. If you don’t have one, you can simply not sell your products within the European Union. The European legislation stipulates the role of a European Authorized Representative Authorized Representative for medical devices, also known as EU Auth. Rep., EC Rep or AR, for manufacturers who don’t have their own location in Europe. EU Authorized Representatives act on behalf of manufacturers to assume, among others, communication with competent authorities.

Under the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR), the EU Authorized Representative for medical devices is assigned a narrowly defined role with the belonging obligations. In short Authorized Representative for medical devices means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer.

Why do you need a European Authorized Representative for medical devices?
As of July 2021, companies located outside the EU, but selling to consumers in the European Union, must have an authorized representative. The role of the authorized representative for medical devices can be summarized as follows:

The authorized representative authorizes the non-EU company to use their address on the packaging (which is mandatory)
The authorized representative holds the technical file, test report, and other relevant compliance documents
The authorized representative communicates with the national authorities (e.g. market surveillance authorities) on behalf of the non-EU company
There are a number of companies acting as European authorized representative for medical devices as a paid service, some of which are listed in this article. These companies normally charge a yearly fee. That said, paying a fee alone is not sufficient, as you must also provide extensive documentation:

Business registration documents
Product liability insurance
Compliance documents (e.g. test reports)
Here is an overview of the registration process:
Upload your technical file
24hour-AR reviews your technical file within 24 hours
You sign the authorized representative agreement
According to the information displayed on the company’s official website, the annual fee is 1,490 Euro for up to 20 products (per client per year, plus VAT if applicable).

Their service includes:

Verification of the EU Declaration of Conformity and technical file
Keeping your compliance documents for 10 years
Providing the legal use of an EU-based address
For an additional fee they can also:

Communicate with the EU authorities on behalf of your company
Handle the product recalls process if needed
Read More - Authorized Representative for medical devices