What is a European Authorized Representative?
A European Authorized Representative is a natural or legal person who acts on behalf of the manufacturer in relation to the CE legislation. Regardless of whether or not a manufacturer is established in the EU, he can designate a European Authorized Representative who will act on his behalf in regard to specified CE legislative tasks. Moreover, it is mandatory for manufacturers of medical devices to designate an authorized representative. The Authorized Representative himself must be established in the EU.
Manufacturers are able to benefit a great deal from designating a European Authorized Representative. The European Authorized Representative acts on behalf of the manufacturer and is able to:
- Affix the CE marking (and, if applicable, other markings), as well as the number of the Notified Body on the product;
- Draw up the EU Declaration of Conformity;
- Keep the EU Declaration of Conformity and the Technical Documentation available for the national market surveillance authorities and make them accessible to the authorities on request;
- Provide the competent national authorities with all the information and documentation needed to affirm the product’s conformity, following a substantiated request;
- Cooperate with the competent national authorities in regard to taking any actions aimed at eliminating the risks.
What can we offer you?
Certification Company can be formally designated as the European Authorized Person, responsible for your product(s) on your behalf.
With a great deal of skills and expertise regarding European (CE) legislation at their disposal, our regulatory compliance experts are capable to take on a great deal of your responsibilities, allowing you to focus more on your core tasks.
Certification Company offers you a modern, flexible system in order to carry out our services as European Authorized Representative:
- We establish our conditions in a clear and understandable agreement;
- Our agreements may be cancelled per quarter;
- Within the scope of our services as European Authorized Representative we also draw up a non disclosure agreement in order to guarantee protection of your intellectual property.
With Certification Company as your European Authorized Representative, you will be offered the following services:
- A complete package of our services as European Authorized Representative;
- We will act as your primary contact with all of the national market surveillance authorities in Europe;
- You will be authorized to affix our trade name and trade logo on your product and the accompanying documentation in order to identiy us as the official European Authorized Representative of your product(s);
- We draw up a non disclosure agreement, completely free of charge, in order to protect your intellectual property;
- We offer advantageous cluster packages in case there is more than one product and / or model;
- Quarterly cancellation of the agreement is possible;
- Large discounts for long term agreements.
What are the costs for designating Certification Company as your European Authorized Representative?
Our tariff structure consists of:
- Quarterly or annual fee at the request of the applicant;
- Guaranteed no extra or unforeseen costs.