Economic Operators Under the MDR and IVDR

This session we explained the roles and responsibilities of economic operators under the MDR and IVDR, including importers, distributors, and authorized representatives. We walked through how each of these parties interacts with the regulatory framework and the compliance obligations they must meet. Daniëlle Sleegers also provided real-world examples of how economic operators play a key role in the lifecycle of medical devices and in-vitro diagnostics.

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Economic Operators Topics Covered

Overview of Economic Operators

In this webinar, we delved into the roles and responsibilities of economic operators under the
MDR and IVDR, from the perspective of notified bodies. Here are some of the key topics and insights
shared by our expert speakers:
Key Topics Covered:

• Economic Operators Overview:
  • Manufacturers, Authorized Representatives (ARs), Importers, and Distributors are the
    four key economic operators under MDR/IVDR.
  • The importance of clearly defining these roles within your Quality Management System (QMS) and ensuring proper contracts are in place.

• Authorized Representatives (ARs):
  • ARs act as the liaison between manufacturers and the EU market, bearing significant legal responsibility for ensuring compliance with regulatory requirements.
  • Their role has become more critical with the MDR, as they share liability with manufacturers
• Importers and Distributors:
  •  Importers are responsible for ensuring that products meet regulatory requirements
    when entering the EU.
  • Distributors handle product storage, transportation, and delivery to end users. Their
    compliance duties were also emphasized.
• Practical Challenges:
  • A common non-compliance issue encountered during audits is the lack of clearly defined
    roles and responsibilities among economic operators. Clear documentation and
    contractual agreements are crucial to avoid major non-conformities during audits.
  • The importance of having a documented process for handling complaints, recalls, and Field Safety Corrective Actions (FSCA) was also highlighted.

Questions Answered:

• What are the most common non-compliance issues during audits of economic operators?
  Key issues included the lack of clear contracts, improper documentation of roles, and confusion
  over responsibilities between the different operators.
• What steps should economic operators take to ensure compliance during recalls or FSCA? It’s crucial to have a well-defined communication flow and responsibility assignment in place, ensuring all economic operators understand their roles in the process.
• How do economic operators stay informed about changes in the MDR/IVDR?
  While notified bodies may not directly inform you about regulatory updates, it’s important for
  manufacturers and economic operators to stay informed via resources like newsletters,
  regulatory updates, and through active collaboration with ARs and other stakeholders.