Common Questions About the Role of the Authorized Representative

Below is a list of the most commonly asked questions about the role and responsibilities of the EU Authorized Representative.

What is an EU Authorized Representative?

An Authorized Representative acts as the regulatory liaison between your company and the national Ministries of Health in the European Union, particularly with regard to vigilance.

Why do I need to appoint an Authorized Representative?

The CE Marking Directives specify that medical device/IVD companies without a location in Europe must appoint someone to represent them to the Competent Authorities (Ministries of Health). As long as you sell in Europe, you need to have an EU Authorized Representative.

Can I appoint a distributor as my Authorized Representative?

Yes, it is possible to do so if the distributor is located within the European Union and is willing and able to perform the regulatory functions required of them. However, there are many reasons not to appoint a distributor as your Authorized Representative. Also, Directive 2007/47/EC indicates that this should be a single Authorized Representative, or at least a single Authorized Representative for all devices of the same model.

Do I have to put the name of the Authorized Representative on our labels, packaging and IFUs?

Yes, you must list the name and address of the Authorized Representative on the product label, outer packaging OR Instructions for Use.

What tasks does the Authorized Representative perform?

Your European Authorized Representative is not simply a name to place on your packaging and labels. They perform a number of important functions and act as your regulatory “eyes and ears” in Europe. Your EC REP can play a role in incident reporting, classification guidance and represent you to Competent Authorities if needed.

What happens if I don’t appoint an Authorized Representative?

Even if you have obtained your CE Marking certificate, you must maintain an Authorized Representative as long as your company does not have a location within the European Union. If you do not appoint one, your products may be stopped at the border of entry into the EU until you prove that you have done so. Customs officials also have the power to quarantine or destroy your products.

Do I need to have a signed contract in place with my Authorized Representative before my Notified Body audit?

As part of the Conformity Assessment requirements for medium and high risk devices, Notified Bodies will determine if you: 1. have selected an Authorized Representative, 2. have a signed contract in place with the Authorized Representative, and 3. if your procedures (such as Vigilance) spell out the activities and responsibilities of the Authorized Representative.

Can a Competent Authority inspect my Authorized Representative?

Yes. A Competent Authority can inspect an Authorized Representative at any time to determine if they understand their role, have direct access to the proper client documentation (such as the Technical File/Design Dossier) and have proper processes in place to ensure it can fulfill its role as an EC REP.