This article helps you understand what an EU authorised representative is and what their general responsibilities are.
An EU authorised representative is any natural or legal entity established within the European Union who has accepted a written mandate from a non-European manufacturer to act on the manufacturer’s behalf in regard to specific tasks. The European directives and regulations describe the tasks that a manufacturer can delegate to the authorised representative and the conditions under which this delegation can occur.
The authorised representative has to perform the tasks stipulated in the mandate received from the manufacturer. Generally, the mandate must allow the EU authorised representative to do at least the following tasks in relation to the product it covers:
Some European directives and regulations (e.g. MDR 2017/745) specify additional obligations for the authorised representative:
An authorised representative’s obligations do not include drawing up technical documentation or ensuring the product’s safety design and manufacture. However, the EAR may draw up an EU declaration of conformity on the manufacturer’s behalf and under their responsibility, provided that this is specified in the mandate.
The mandate is usually several pages long and provides a detailed summary of both the manufacturer and the authorised representative’s responsibilities, duties, and rights. It must also include information allowing the identification of the product it covers (e.g. product name and model number). The written authorisation may also define the arrangements for a change of the authorised representative, addressing the following aspects:
The mandate always includes a confidentiality clause, stating that all parties are obligated to observe confidentiality with regard to all information. An authorised representative agreement also includes a penalty clause in case of a contractual violation by the manufacturer to prevent the EAR’s exposure of being on the receiving end of a manufacturer’s liabilities.
Clever Compliance is a Swedish RegTech company that provides compliance assistance to any type or size of businesses. We are known for developing innovative digital compliance solutions, such as our compliance management system, and providing reliable certification services to product manufacturers.
We can also act as an authorised representative under several European directives and regulations. Our authorised representative service package includes:
If your business is based outside of the European Union, and you are required to have an authorised representative, get in touch with our team at [email protected], and we will do our best to assist you.