Manufacturers based outside the EU or EEA require an authorized representative with an establishment within the EU or EEA to place medical devices on the market in accordance with the MDR. Affected are devices of all classes (also class I), which are placed on the market under the MDR. Devices imported with an EC certificate according to the MDD and AIMDD directives may continue to be placed on the market during the Grace Period (until max. May 2024).
Generally, in addition to an external expert, an importer/distributor or a subsidiary of the manufacturer based in the EU area can also act as a authorized representative. However, with the disclosure of the technical documentation or in case of incidents on the market, economic and moral conflicts of interest may arise.
Both the authorized representative and the manufacturer must have access to specialists with identical requirements. The minimum professional requirements for the authorized representative are listed in the MDR in article 15.
The process starts with a simple form so that we can create an offer tailored to your needs.
Subsequently, we clarify the further cooperation, the necessary interfaces and conclude this phase with the contract. After that we will check the technical documentation of your products. The process is completed with the registration of the products.
The entire process is digital, if desired, all documents can also be completed and signed in paper form.
A manufacturer may appoint different authorized representatives for different products. However, individual authorized representatives must be designated at least for all products of a generic product group (according to MDR Art. 2, No. 7). It should be noted that a higher number of authorized representatives as well as a change of the authorized representative may lead to increased costs in connection with the product labeling obligation (see obligations of the Manufacturer).
According to MDR Article 11, the Authorized Representative is subject to “extended liability”. This means that the authorized representative is jointly and severally liable with the manufacturer for defective products if he fails to comply with his obligations under the MDR.
For this reason, Axxos GmbH reviews the technical documentation before market approval. Thus, you can be sure that the regulatory requirements are met.
The manufacturer must provide the Authorized Representative with all documents relevant to the product for checking the technical documentation and for product registration without any gaps. The products must be labeled with the name and address of the Authorized Representative using the symbol from ISO 15223-1. The name, address as well as the Single Registration Number (SRN) of the authorized representative must be indicated on the declaration of conformity.
The following obligations of the manufacturer may not be delegated to the authorized representative (MDR Art.11, Para.4):
- Ensuring product conformity and drawing up the declaration of conformity
- Drawing up the labeling and instructions for use
- Performing clinical evaluations
- Writing and updating the technical documentation
- Maintaining the manufacturer's quality management system
- Setting up the post-market surveillance system
- Determining necessary corrective actions
- Maintaining the UDI database.
A summary of the legislative changes and obligations of manufacturers associated with the MDR can be found in the EU Factsheet.