Why you should not appoint your Distributor as EU Authorized Representative?
1. Regulatory Compliance
An EU Authorized Representative will be responsible for verifying your compliance with the applicable conformity assessment procedure as well as the correct classification of your devices. Your Authorized Representative will have detailed knowledge of all the individual regulations of each of the 27 EU member states.
2. Technical File
Your EU Authorized Representative will have to retain a copy of your Technical File and must allow the competent authorities of all 27 member states access to that information and data.
3. Incident Reporting & General Surveillance
Your EU Authorized Representative will be aware of incidents in all EU member states. He will handle sensitive product information, like European market information, distributor lists etc. An Authorized Representative may be required to make decisions that are contrary to a distributor’s interests, such as product recalls. As such, the Authorized Representative must be able to decide fully independently and to your best regulatory interests at all times.
4. Independence & Neutrality of your Authorized Representative
An EU Authorized Representative must remain neutral in all actions, including being neutral towards possible competitive Distributors.
One should be aware of the inherent risk in appointing one of your European Distributors. This practice will inevitably lead to a hierarchical situation amongst your Distributors, those not appointed as Authorized Representative would perceive themselves as less significant, especially as only the Authorized Representative’s name appears on the labeling.
As it is a legal requirement to include your Authorized Representative’s details on your labels and packaging, changing your Authorized Representative is expensive, inefficient and cumbersome. It involves the reprinting of labels and packaging with the new Authorized Representative’s details, as well as scrapping of all printed stock on hand. It is strategically prudent to appoint an independent representative at the outset thus avoiding unnecessary complications, expense and discontentment later.
Appointing a Distributor as Authorized Representative can cause a serious conflict of interest for you in the European market. Please bear that in mind when deciding who to appoint as your Authorized Representative.