Economic Operators FAQ
Q: What does "Economic Operator" mean?
A: In the context of the MDR/IVDR, an
Economic Operator refers to any entity involved in the medical device supply
chain that facilitates the placing of a medical device on the EU market. These
entities include Manufacturers, Authorized Representatives, Importers, and
Distributors, collectively known as MAID. Each Economic Operator has distinct
roles and obligations regarding regulatory compliance.
Q: Who are the Economic Operators?
A: The Economic Operators are Manufacturers, Authorised Representatives, Importers and Distributors.
Q: What are their specific roles and responsibilities?
- Manufacturers are responsible for design, development, manufacture, assembly, handling, storage, distribution, corrective actions, UDI labelling, complaints, post-market surveillance, and PRRC.
- Authorised Representatives act on behalf of a manufacturer outside the EU to meet MDR obligations, including EUDAMED registration, maintaining technical documentation, documentation check, audit support, post-market surveillance, and PRRC.
- Importers are responsible for placing non-EU products on the EU market. Their obligations include EUDAMED registration, maintaining technical documentation, ensuring proper labelling, verifying IFU compliance, and PRRC.
- Distributors provide a product from another manufacturer up to the time of commissioning. Their obligations include ensuring CE marking, EU declaration of conformity, UDIs, traceability, labels, and instructions for use, verifying importer name on devices, participation in corrective actions, and PRRC (not required).
Q: What is the role of the Person Responsible for Regulatory Compliance (PRRC) in the MDR?
A: The PRRC is a unique role introduced by the MDR. The PRRC is responsible for maintaining the compliance status of medical devices within an Economic Operator. They must possess appropriate certifications and expertise for MDR compliance, including relevant medical device knowledge and at least one year of experience with Quality Management Systems (QMS) for medical devices. The PRRC ensures device conformity, oversees recall processes, post-market surveillance, and availability of device declarations of conformity and technical documentation when requested.
Q: Why is Economic Operator framework compliance important?
A: Compliance with the Economic
Operator framework is crucial for entities involved in the medical device
industry within the EU. Legal liability is tied to the roles and obligations of
Economic Operators. Understanding and meeting these responsibilities are vital
for continuing business in the European Union and ensuring the safety and
efficacy of medical devices on the market.
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