Most CE regulations require you to keep your product’s Technical File in Europe, or to appoint a person who you authorize to compile the Technical File when the authorities request.You may choose to give the Technical File to one of your European distributors. However, many manufactures do not prefer to give the Technical File to their distributors, because it contains a lot of confidential design and manufacturing documentation they do not want to disclose to the distributor. Also, many manufacturers want the keep the flexibility to change a distributor. And the distributor may be excellent in selling, but does he have the required knowledge and experience with regulatory affairs? Like many manufacturers, you can choose to appoint an Authorized Representative to retain your Technical Files and handle the requests from the European authorities.
Choose your Authorized Representative wisely. You don’t want to end up with a cheap, one day company that disappears when you need it the most. Search for a reliable regulatory expert with experience in your field.
Click ‘Continue’ to read why our Authorized Representative service is an excellent choice.