Authorized Representatives (ARs) carry significant responsibility toward their clients and actively contribute to traceability and product safety through collaboration with stakeholders such as importers. In this FAQ, we clarify responsibilities under MDR and EUDAMED and specifically address UDI management for clients.

Distributors and importers work with manufacturers or their Authorized Representatives (ARs) to enhance product safety. The MDR/IVDR clearly defines the responsibilities of each actor. In addition to mandatory tasks, ARs can support their clients with optional services—such as submitting UDI data to EUDAMED.

Responsibilities under MDR/IVDR

The responsibilities of Authorized Representatives are primarily outlined in Article 11 of the MDR/IVDR. ARs are appointed by manufacturers who are not established in the EU and require an AR for market access.

They are responsible for:

• Verifying that the EU Declaration of Conformity and technical documentation have been prepared and that the manufacturer has undergone the appropriate conformity assessment procedure, if applicable.
• Keeping copies of all documentation available to provide to authorities upon request.
• Cooperating with authorities on preventive and corrective actions and promptly forwarding complaints and sample requests to the manufacturer.

Additionally, the AR shares liability with the manufacturer (if the manufacturer is not EU-based) if the manufacturer fails to meet regulatory obligations.

FAQ for Authorized Representatives on EUDAMED

Which documents must an AR retain?

According to Article 11(3)(b) MDR/IVDR, the following documents must be retained in copy, including all amendments and supplements:

• Technical documentation
• Declarations of conformity
• Certificates

Does the AR need to verify data in EUDAMED?

Yes, the AR must verify in EUDAMED that the manufacturer has registered all required information.

Can the AR submit UDI data to EUDAMED on behalf of clients?

Yes, manufacturers can delegate the submission of product master data in EUDAMED to their ARs. This service is especially attractive to SMEs and startups.

How should an AR respond if the manufacturer fails to meet obligations?

If a manufacturer fails to meet its obligations, the AR should terminate the mandate and inform the Notified Body and the competent authority of the Member State where the AR is established, including the reasons for termination.

Are there tasks that cannot be delegated to the AR?

Yes, some responsibilities must be fulfilled by the manufacturer alone, such as the quality management system and the creation of technical documentation.

Why is cooperation between ARs and tracekey beneficial?

Tracekey is a software provider offering solutions for medical device manufacturers who want to submit and centrally manage UDI data in EUDAMED. We do not offer regulatory consulting ourselves. To provide our clients with suitable contacts in this area, we cooperate with Authorized Representatives. Since data management varies widely among manufacturers, ARs benefit from offering a standardized approach—such as our UDI Manager.

Benefits for Manufacturers and ARs when ARs handle UDI submission

Regulatory Assurance

• Clients benefit from professional UDI uploads by experienced ARs using validated software.
• Reduces errors that could lead to rejection or delays in EUDAMED submission.

Time and Resource Savings

• tracekey handles technical complexity—ARs coordinate the process efficiently.
• Standardized processes, automation, and intuitive dashboards simplify UDI management.

Transparency & Control

• Clients have access to their data and can track changes.
• A well-designed role concept ensures transparency.
• Audit trails provide traceability for manufacturers and authorities.

Faster Market Access

• Smooth UDI uploads accelerate EUDAMED registration—and thus EU market access.
• Especially important for manufacturers with large product portfolios or tight timelines.

Reliable Point of Contact

• Clients have a central contact for regulatory and UDI management questions.
• tracekey supports in the background with EUDAMED expertise and IT know-how.

Scalability for Product Portfolios

• Even manufacturers with thousands of products can submit UDI data efficiently and in a structured way.
• The software supports multi-client setups and large data volumes.

Authorized Representatives can use the mytracekey UDI Manager to offer an efficient and scalable UDI management service without developing their own solution or manually entering unverified data. Instead, they can rely on an automated and well-designed software solution. Tracekey is an established and reliable partner, working with healthcare companies for over ten years. We offer our partners various cooperation models tailored to their client portfolios