Hi All,

I was thinking of one way that getting a medical device approved in the EU may be more difficult than in the USA and only thought of one: It may be difficult for a small, US based company to have an authorized representative. Small companies may not be able to afford or obtain an Authorized Representative in the EU. Even though there are private companies who acts an authorized representative, it seems like a difficult process for a smaller company without as much funding and no European base to begin.

Has anyone had any experience in finding an authorized representative in the EU?

-Andrew Nashed