In response to the adoption of 5 new amendments on September 21, 2007 regarding the role and duty of the European Authorized Representative, Obelis’ C.O.O. and regulatory expert, Miguel Ohn, discusses why it may not be in the manufacturer’s best interests to use their European distributor as a European Authorized Representative (E.A.R.)
First, manufacturers are encouraged not to use one of the European distributors as their E.A.R. even if the distributor offers this service for free. It is important to note that appointing a distributor may require him/her to make decisions contrary to his/her own interest and/or to your international sales objectives.
In addition, it is important to remember several key points and ask yourself the following questions. Your E.A.R. will be responsible for observing your compliance with the conformity assessment procedure; are you comfortable having your distributor measure this compliance? An E.A.R must keep the product’s Technical file available at any time for the EU member state authorities; do you want your distributor to have access to this technical file? An E.A.R. will handle your sensitive product information, trade secrets, European market information, distributor lists etc.; do you want your distributor to be aware of such incidents that will affect the way he/she handles your product? Additionally, do you want your distributor handling your confidential product information while potentially handling competitor products?
Finally, it will be costly for you to change your distributor acting as your E.A.R. because products carrying the distributor’s/E.A.R.’s name on all labeling, catalogs, instruction sheets and packaging will be on the European market long after the distributor has changed.
In general, it is in the manufacturer’s best interest to appoint an E.A.R. that is not their distributor. It is very important to understand what your E.A.R. should be doing for you as well as their specific role and duties. Please visit www.obelis.net for more information and for regulatory guidance for your products.