Commonly asked questions about Authorized Representation
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Below is a list of the most commonly asked questions about the role and responsibilities of the EU Authorized Representative.
What is an Authorized Representative?
An Authorized Representative acts as the regulatory liaison between your company and the national Ministries of Health in the European Union.
Why do I need to appoint an AR?
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, otherwise known as the National 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 Rep?
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.
Do I have to put the name of the AR on our labeling, packaging and IFUs?
You must list the name and address of the Authorized Rep on the product label, outer packaging OR Instructions for Use. The name and address of the Authorized Representative must be shown next to the official EC REP logo shown below.
What tasks does the Authorized Representative perform?
Your European Authorized Representative is not simply a name to place on your outer packaging an labels. They perform a number of important functions and act as your regulatory "eyes and ears" in Europe.
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 AR 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 AR, 2. have a signed contract in place with the AR, and 3. if your procedures (such as Vigilance) spell out the activities and responsibilities of the Authorized Rep.
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, are maintaining the necessary/have direct access to the proper client documentation (such as the Technical File/Design Dossier) and has proper processes in place to ensure it can fulfill its role as an Authorized Rep.
Please contact us for a free consultation and no-obligation proposal on European Authorized Representative services.
Related services offered by Emergo Group:
- US Agent representation for FDA
- ISO 13485 quality system implementation or upgrade from ISO 13485:1996
- CE Marking consulting services for medical devices
- Medical distributor search and management for Europe and USA
- SEE ALL QUALITY ASSURANCE AND REGULATORY AFFAIRS SERVICES
