Economic Operators and Article 10a: What You Need to Know

As of January 10, 2025, Article 10a under the EU MDR and IVDR introduces significant responsibilities for economic operators, including importers, distributors, and authorized representatives. These stakeholders play a vital role in maintaining the medical device supply chain, and preparation is key.

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The Role of Economic Operators

Economic operators act as intermediaries in the supply chain, ensuring that critical information about device availability is shared downstream. When notified of supply issues by manufacturers, they must:

1. Relay Notifications Promptly
   Economic operators must communicate supply interruptions or discontinuations to healthcare providers and institutions without altering the content provided by the manufacturer.
2. Support the Communication Chain
   Operators must ensure that stakeholders further down the supply chain—such as smaller distributors—receive timely and accurate updates.

Compliance Requirements

1. Timely Action
   Notifications must be passed along “without undue delay.” Operators should have systems in place to quickly identify all affected customers and stakeholders.

2. Contractual Clarity
   Contracts with manufacturers should clearly define roles and responsibilities under Article 10a. This helps avoid legal ambiguities and ensures seamless compliance.

3. Data Integrity
   Operators must ensure that the information they share is consistent with the manufacturer’s notifications. Modifications are not allowed, as the responsibility for follow-ups lies solely with the manufacturer.

Practical Challenges

• Supply Chain Complexity
  Identifying affected stakeholders quickly can be challenging, particularly for larger operators managing extensive networks.

• Legal Risks
  Missteps in communication or delays can lead to reputational damage or penalties. Economic operators must also safeguard against sharing sensitive information improperly.

Preparing for January 2025

To meet these challenges, economic operators should:

• Review Agreements: Ensure contracts with manufacturers outline Article 10a obligations.
• Strengthen Systems: Implement technology to track and communicate with affected stakeholders rapidly.
• Provide Training: Equip teams with the knowledge to handle Article 10a requirements effectively.

By taking these steps, economic operators can align with Article 10a and maintain the integrity of the medical device supply chain, ultimately safeguarding patient health.