Economic Operator

An Economic Operator is any natural or legal person who has a role in making medical devices available on the market in the European Union. This includes manufacturers, authorized representatives, importers, and distributors. The EU MDR defines specific obligations for each type of economic operator to ensure devices remain safe and compliant throughout the supply chain.

Types of economic operators under EU MDR:

1. Manufacturer (Article 10):
The person who:
- Manufactures or fully refurbishes a device
- Has device designed, manufactured, or refurbished
- Markets device under their name or trademark

Responsibilities:
- Design and manufacture per MDR requirements
- Establish quality management system
- Compile technical documentation
- Conduct clinical evaluation
- Perform conformity assessment
- Draw up Declaration of Conformity
- Affix CE marking
- Register in EUDAMED
- Implement post-market surveillance
- Report incidents and field safety corrective actions

2. Authorized Representative (Article 11):
A person established in the EU appointed by a non-EU manufacturer.

Responsibilities:
- Verify Declaration of Conformity and technical documentation exist
- Keep technical documentation available for authorities
- Provide authorities with information and documentation
- Cooperate on corrective actions
- Immediately inform manufacturer of complaints and incidents
- Terminate mandate if manufacturer acts contrary to obligations

3. Importer (Article 13):
A person established in the EU who places a device from a third country on the EU market.

Responsibilities:
- Verify manufacturer and device comply with MDR
- Verify CE marking and required documentation present
- Verify device properly labeled and accompanied by instructions
- Register in EUDAMED
- Ensure device properly registered and has UDI
- Store and transport per manufacturer's conditions
- Keep record of complaints and non-conforming devices
- Inform manufacturer and authorities of serious incidents
- Maintain complaint handling system

4. Distributor (Article 14):
Any person in the supply chain who makes a device available on the market (excluding manufacturer or importer).

Responsibilities:
- Verify device has CE marking and required documentation
- Verify device accompanied by required information
- Store and transport per manufacturer's requirements
- Maintain traceability
- Report serious incidents and non-compliant devices
- Cooperate with authorities

When economic operators assume manufacturer obligations:

Importers become manufacturers if they:
- Place device on market under their name or trademark
- Change intended purpose of device already on market
- Modify a device in a way that may affect compliance

Distributors become manufacturers if they:
- Place device on market under their name or trademark
- Change the intended purpose of a device
- Modify a device already on market in a way that may affect compliance

Traceability requirements for all economic operators:

Forward traceability:
- Record to whom devices were supplied
- Customer name and address
- Device identification (UDI if applicable)
- Quantity supplied
- Date of supply

Backward traceability:
- Record from whom devices were received
- Supplier name and address
- Device identification
- Quantity received
- Date of receipt

Retention period:
- Minimum 10 years after device placed on market
- Minimum 15 years for implantable devices
- Available to authorities upon request

Registration obligations:

All economic operators must:
- Register in EUDAMED before placing device on market or putting into service
- Obtain Single Registration Number (SRN)
- Maintain up-to-date registration information
- Update registration when changes occur

Information to register:
- Name, address, contact details
- SRN (assigned by system)
- Role as economic operator
- Devices placed on market or put into service
- Certificates (for manufacturers)

Vigilance and post-market surveillance:

Incident reporting:
All economic operators must report:
- Serious incidents to manufacturer and authorities
- Any malfunction or deterioration that could lead to serious incident
- Field safety corrective actions

Cooperation requirements:
- Provide samples or access to devices when requested by authorities
- Provide all information and documentation needed to demonstrate conformity
- Cooperate in actions taken to eliminate or mitigate risks

Supply chain coordination:

Economic operators must work together to ensure:
- Devices remain compliant throughout their lifecycle
- Information flows through the supply chain
- Incidents are promptly reported
- Field safety corrective actions are implemented
- Recalls are executed efficiently

Example supply chain:
Manufacturer → Authorized Representative → Importer → Distributor → Healthcare Facility

Each economic operator has specific obligations at each stage.

Documentation requirements:

What must be available:
- Declaration of Conformity
- Instructions for Use (IFU)
- Labels and markings (including UDI)
- Certificates (for higher-class devices)
- Technical documentation (upon request by authorities)

Language requirements:
- Instructions and labeling in official language(s) of member state where device is made available
- Economic operators must ensure language compliance in their jurisdiction

Consequences of non-compliance:

Economic operators face penalties for failing obligations:
- Warning letters from competent authorities
- Product recalls or corrective actions
- Fines and financial penalties (vary by member state)
- Prohibition from placing devices on market
- Criminal liability in some cases
- Reputational damage

Due diligence obligations:

Before making device available, economic operators should:
- Verify legitimacy of suppliers
- Check authenticity of products
- Ensure proper documentation exists
- Verify CE marking validity
- Check EUDAMED registrations
- Verify certificates with Notified Body
- Assess supplier quality management systems

Practical challenges:

For importers:
- Verifying compliance of foreign manufacturers
- Managing language requirements for multiple markets
- Coordinating with non-EU manufacturers on incidents
- Maintaining traceability across borders
- Managing customs and regulatory clearances

For distributors:
- Handling devices from multiple manufacturers with varying requirements
- Maintaining traceability in complex distribution networks
- Responding quickly to recalls and FSCAs
- Ensuring proper storage conditions
- Managing inventory of devices with different UDI requirements

For authorized representatives:
- Balancing obligations to authorities and manufacturer
- Ensuring manufacturer maintains compliance
- Managing communication with multiple competent authorities
- Deciding when to terminate mandate for non-compliant manufacturer

Best practices for economic operators:

1. 1Quality management: Implement QMS for economic operator activities
2. 2Training: Regular training on MDR obligations and updates
3. 3Documentation: Robust document control and retention systems
4. 4Traceability: Automated systems for tracking devices through supply chain
5. 5Vigilance: Clear procedures for incident reporting and handling
6. 6Audits: Regular internal audits and supplier evaluations
7. 7Contracts: Clear agreements defining responsibilities among economic operators
8. 8IT systems: Use of EUDAMED and automated compliance tools
9. 9Communication: Established channels with authorities, manufacturers, and other operators
10. 10Contingency planning: Procedures for recalls, FSCAs, and supply disruptions

Relationship to competent authorities:

Competent authorities may:
- Request information and documentation from any economic operator
- Conduct inspections of economic operators
- Access facilities and documentation
- Take samples for testing
- Issue corrective actions or prohibitions
- Impose penalties for non-compliance

Economic operators must:
- Respond promptly to authority requests
- Provide access to facilities
- Cooperate with investigations
- Implement corrective actions when required

Multi-country considerations:

Economic operators selling in multiple EU member states must:
- Understand that competent authorities in each country can enforce MDR
- Maintain relationships with multiple authorities
- Ensure labeling meets each country's language requirements
- Report incidents to relevant authorities per MDR rules
- Navigate different interpretations of MDR requirements

The economic operator framework ensures that all parties in the medical device supply chain share responsibility for safety and compliance, with obligations proportional to their role and ability to influence device quality and safety.