EU authorized representative and responsible person of the representative

A) The tasks you can hand over to us

1. EU representative

Manufacturers which do not have a branch in a Member State must nominate an authorized representative. This authorized representative represents the manufacturer in the EU and is "jointly and severally liable in law".

The MDR obliges authorized representatives to fulfil the following tasks:

• Check that the EU declaration of conformity and the technical documentation have been created
• Hold a copy of the current technical documentation
• Serve as a link between the manufacturer and the competent national authorities, for example
  • Communicating with authorities and answering their questions
  • Provide authorities with documents they request
  • Support authorities in corrective and preventive measures
• Inform the manufacturer about complaints from users
• Ensure that the products and manufacturer are registered

We can take on all of these tasks if you wish.

One thing worth noting: manufacturers who are still marketing their products in accordance with EU directives (MDD, IVDD, AIMDD) must also fulfill the obligation to have an authorized representative.

2. Person responsible for compliance with regulatory requirements at the authorized representative

Both manufacturers and the authorized representative must have access to a responsible person. The authorized representative's responsible person must be domiciled in the EU (see MDCG 2019-7). 

As an authorized representative, we provide the appropriate responsible person and thus ensure fulfilment of the authorized representative's prescribed tasks according to Article 11 of the MDR.

B) Establishing cooperation

We establish our cooperation in several steps so that things run smoothly from the beginning. This level of clarity minimizes unnecessary work and costs and creates the basis for legally compliant work for all parties.

This helps prevent regulatory risks.

1. Get to know each other, draw up NDA

We conclude a non-disclosure agreement and get to know you and your product(s) on a non-binding basis. For example, we hold an initial telephone conversation in order to answer the following questions:

• Which products do you wish to bring onto the market?
• How are these products classified?
• What conformity assessment procedures have you performed for these products?
• Have you already identified, named and registered the other economic operators (e.g. importers)?

2. Estimate costs and work, prepare quote

Then we discuss which role(s) you would like us to take on. We estimate the expenses for the activities; expenses depend on factors such as:

• type and number of roles (authorized representative, responsible person) we take on;
• type and number of products;
• scope of documentation.

These expenses determine the costs, which we break down in a tailor-made offer

3. Review existing documents

As part of a workshop, for example, we check the completeness and conformity of the "product documents" (technical documentation) and the QM documents (specification documents, records). This review gives us a common understanding of all documents and processes.

We also draw up a list of measures to remedy any non-conformities. If we are acting as your authorized representative, this list of measures includes the task of identifying us as such on the label.

4. Implement measures, define processes

We implement the measures we have jointly agreed and establish the processes of our cooperation:

• Set up a collaboration platform to exchange documents.
• Set up a collaboration platform to exchange documents.
• Adapt processes and work instructions.
• Draw up a contract on cooperation.
• Register us as an authorized representative or responsible person.

Then we are ready to get started!

C) Next steps