Expanding into Europe: the importance of an authorised representative for SaMD manufacturers

In our previous article, we explored the key steps allowing SaMD manufacturers to obtain CE marking and access the European market (see our article: "How to commercialise your medical device in Europe?"). One of the requirements of the Medical Devices Regulation (EU) 2017/745 (MDR) is the designation of an Authorised Representative (AR). Indeed, non-European manufacturers must appoint a representative to ensure liaison between the manufacturer and the competent European authorities. This role is essential to ensure compliance, manage regulatory obligations and facilitate market access.

In this article, we examine the importance of appointing an Authorised Representative.

Why is the appointment of an Authorised Representative mandatory?

Under article 11 of the MDR, the Authorised Representative acts as the legal representative of a non-EU manufacturer within the European Union and assumes several responsibilities:

• Verify the Declaration of Conformity and the conformity of the Technical Documentation.
• Hold a copy of the Technical Documentation and make it available to the competent authorities.
• Cooperate with the competent authorities.
• Inform the manufacturer in case of incident.

➡️ Without an Authorised Representative (or a subsidiary in the territory), your software cannot be marketed in Europe.

The Authorised Representative is not the only one with responsibilities. The manufacturer (non-EU company) must also:

• Ensure that the medical device complies with MDR requirements before its market launch.
• Establish and maintain Technical Documentation compliant with the MDR.
• Implement a Quality Management System (QMS) compliant with ISO 13485.
• Conduct clinical evaluations (both pre-market and post-market).
• Ensure compliance with post-market surveillance requirements.
• Register the manufacturer and its devices in EUDAMED and ensure compliance with the UDI system.

Conclusion

Entry into the European market with a SaMD begins with obtaining CE marking. Only then can US manufacturers appoint an Authorised Representative, as required by the Medical Devices Regulation (EU) 2017/745 (MDR). The Authorised Representative plays an essential role in ensuring compliance and facilitating market access.