As a part of the CE marking process, you compile a Technical File of all documentation ensuring your product’s CE marking compliance with the applicable CE marking directives. According the CE requirements, a full copy of this Technical File must be kept in Europe.
If your company is located outside Europe, you will have to find a person or company to retain the Technical File. 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 s/he have the required knowledge and experience with regulatory compliance?
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.
We can help!
Appoint Alura Group as your Authorized Representative, and we’ll retain your products’ Technical Files and keep them available for the European authorities to review upon their request. By appointing Alura Group, your company will not need to share its trade secrets with its distributors. Also, you will not need to give one European distributor a preferred position over another, and thus keep all of them happy.
Alura Group will be your company’s formal point of contact for the European competent authorities concerning CE compliance matters. Alura Group is highly experienced and professional. We’ll help your company to meet its regulatory responsibilities, while at the same time safeguarding the confidentiality of its trade secrets.
What are the advantages of using Alura Group as my independent Authorized Representative?
- Alura Group has a neutral role and no commercial involvement in distributing or selling your products. This means Alura Group DOES NOT compete with your distributors and/or agents;
- Alura Group has in depth understanding of the tasks and responsibilities of an Authorized Representative;
- Alura Group is experienced and well versed in the areas of CE marking and related regulations;
- Alura Group has access to network of reputable testing houses and Notified Bodies.
What will you get?
We’ll provide you with all your company needs to comply with its legal responsibilities. And I think you’ll find our fee very reasonable.
- Alura Group will keep a full copy of your product’s Technical File.
- Alura Group offers a point of contact in the European Union for the communication with competent authorities, accessible during European office hours. Our name address, telephone number, fax number and email address may be printed on product labels, users manuals, brochures, the Declaration of Conformity etc.
- Our excellent CE marking specialists will handle all inquiries and communication on your behalf. Of course, you will be kept informed about all communications.
- Our experts are ready to help you with your regulatory compliance questions.
- Alura Group will keep you informed of latest relevant developments in the CE regulations.