Economic Operators in the In Vitro Diagnostic Regulation (IVDR)

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Within this blog, we will explain the significance of “economic operators” in the IVDR Regulation (EU) 2017/746 and provide a comprehensive explanation of their roles and responsibilities. Economic operators are essentially entities involved in the IVD medical device product life-cycle , they include the following roles:

Manufacturers: Companies who design, produce, and market the IVD device. Their duties include ensuring that the IVD device complies with the necessary safety and performance requirements, it is correctly classified according to the risk-based classification system, and that an appropriate quality management system is implemented.

Importers: Entities that bring the IVD device into the European Union (EU). Importers must verify the manufacturer’s compliance with IVDR, including the CE marking, EU Declaration of Conformity, and the device’s labelling.

Distributors: Parties involved in the supply and distribution of the IVD device. Distributors have a duty to maintain a traceability system and to monitor the IVD device on the market.

Authorized Representatives: Non-EU manufacturers must appoint an EU-based Authorized Representative. They share the manufacturer’s liability and ensure compliance with IVDR.

One of the critical changes in the IVDR compared to the IVDD is the explicit and detailed responsibilities placed on each economic operator. Under the IVDR, every operator in the supply chain must verify and maintain the regulatory compliance of the IVD devices they handle, imposing an accountability chain from the manufacturer through to the distributor.Economic operators have the following key responsibilities:

Vigilance and Post-market surveillance: Economic operators play a significant role in ensuring the continual safety and performance of IVD devices on the market. They are required to report any serious incidents, technical or medical reasons leading to a systematic recall, and any safety corrective actions taken.

Traceability: Economic operators need to maintain a robust traceability system through the Unique Device Identification (UDI) system. It involves assigning a unique code to each device that will follow it from manufacturing to end-use.

Verification of Compliance: Importers and distributors have a role in verifying the compliance of the IVD devices they import or distribute. This includes verifying the existence of the EU declaration of conformity and the CE marking, the UDI, and the languages used in the accompanying documents.

Cooperation with Manufacturers and Authorities: Economic operators must cooperate with manufacturers and competent authorities to ensure that the necessary corrective action is taken to remedy any non-compliance.

The IVDR has greatly expanded the responsibilities of economic operators, pushing them into a more proactive role in ensuring regulatory compliance, post-market surveillance, and traceability of IVD devices. This shift emphasizes the commitment of the EU to ensure patient safety and effective performance of IVD devices throughout their lifecycle.

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