Reasons to appoint a professional EC REP instead of a distributor

Some companies opt to use a distributor as their EC REP (Authorized Representative.) While this is legal, many distributors are not aware of the responsibilities of the EC REP. There are other issues to consider.

1. The Authorized Representative’s name must appear on device labeling, no matter where your products are sold in Europe.

If you decide to change distributors, and this distributor is your Authorized Representative, you will have to reprint device labels, manuals or packaging. Furthermore, you will be presented with a challenge on how to deal with the products already on the market that have that the old distributor’s name on them. Finally, selecting distributor among several in the EU to be your Authorized Representative may create resentment among other distributors.

2. Your distributor focuses on selling your medical devices, not on regulatory affairs.

If the European laws and guidelines are modified, are you sure your distributor will keep abreast of these changes and notify you when changes affect your devices? In the regulatory affairs world, ignorance is not bliss. As a professional regulatory affairs consultancy, we keep updated on changes to EU legislation and inform our clients accordingly.

3. Your distributor, as your Authorized Representative, may have access to your Technical Files.

If a Competent Authority has questions about your medical device they will contact your EC REP to review the Technical File. That means your distributor, if they act as your EC REP, will have access to your Technical File which may include proprietary design and other technical information.

A related issue deals with recall and (near) incident reporting. If a Competent Authority questions an incident or a non-compliance that occurred with your product, can you be sure your distributor will defend your company or protect their own interests? Even if you intend to sell in a few countries through a single distributor, the potential downside of the issues noted above are generally not worth the small amount of money you will save. The annual cost of appointing an EC REP is quite small. You should weigh the risks versus benefits of such a decision.

Regardless of whether you decide to choose a distributor or an independent party as your EC REP, you should select someone who knows the requirements and responsibilities. The Authorized Representative should be able to demonstrate experience in the business.

Please contact us for a free consultation and no-obligation proposal on European Authorized Representative (EC REP) services.