This article helps you understand what an EU authorised representative is and what their general responsibilities are.
What is an EU authorised representative?
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.
What are the responsibilities of an EU authorised representative?
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:
- Keep the product’s technical documentation and EU declaration of conformity at the disposal of national regulatory authorities for 10 years (in some cases – 5 years) after the product has been placed on the market.
- Provide the national market surveillance authorities with all the information and documentation required to demonstrate the product’s CE conformity.
- Cooperate with the market surveillance authorities on preventive and corrective actions to eliminate the risks posed by the product.
- Deliver a copy of the mandate to the national authority, upon request.
Some European directives and regulations (e.g. MDR 2017/745) specify additional obligations for the authorised representative:
- Verify that the manufacturer has complied with specific registration obligations.
- Inform the manufacturer immediately about complaints and reports from users about suspected incidents related to the product.
- Forward to the manufacturer any request made by a competent authority for product samples or access to the product and verify that the competent authority receives the samples or is given access to the product.
- Terminate the mandate if the product manufacturer acts contrary to their obligations under the relevant EU directive/regulation.
- Immediately inform the competent national authority and, where relevant, the notified body that carried out the conformity assessment for the product of the termination of the mandate and the reasons therefor.
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.
What does a mandate include?
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 date of termination of the outgoing EU authorised representative, and the date of the beginning of the incoming EU authorised representative’s mandate.
- The date until which the outgoing EU authorised representative may be indicated in the manufacturer’s information.
- The transfer of documents, including property rights and confidentiality aspects.
- The obligation of the outgoing EU authorised representative after the end of the mandate to forward to the manufacturer, or incoming EU authorised representative any complaints or reports from users about suspected incidents related to the product.
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.
How can we help?
Clever Compliance is a Swedish RegTech company that provides compliance assistance to any type or size of businesses. We are known for developing innovative compliance solutions like our compliance management system and supplier compliance software with SCIP integration. Additionally, we also provide reliable certification services to product manufacturers.
We can act as an authorised representative under several European directives and regulations. Our EU authorised representative service package includes:
- Use of our name and registered address within the EU.
- An official appointed contact address for EU regulatory agencies.
- Authentic certificates of representation.
- A thorough review of the EU declaration of conformity and technical documentation for compliance.
- Assistance in communication between the manufacturer and the competent regulatory authority.
- Updates regarding regulatory changes that might impact the compliance status of the product
- Ad-hoc consultancy and support
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.