Frequently Asked Questions
Do I have to put the name of the AR on our labeling, packaging and IFUs?
Yes. You must list the name and address of the Authorized Rep on the product label, outer packaging and/or Instructions for Use. The name and address of the Authorized Representative should be shown next to the official EC REP logo.
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 client documentation such as the Technical File/Design Dossier and have processes in place to ensure it can fulfill its role as an Authorized Representative.
Can I change Authorized Representatives after I appoint one?
Yes. You may switch your EC Rep without invalidating your product approvals in Europe. However, keep in mind that because your EC Rep must be printed on your labeling, switching can be somewhat costly as you will need to change labeling and deal with the issue of products that are already on the market.