Importer

An Importer is an entity that places a medical device manufactured outside a regulatory jurisdiction (third country) onto the market of that jurisdiction. Importers serve as the legal link between foreign manufacturers and local markets, assuming critical regulatory responsibilities to ensure device compliance and patient safety. The role and obligations of importers differ between the EU and USA regulatory frameworks.

EU MDR importer requirements:

Definition and role under EU MDR 2017/745:

The EU Medical Device Regulation defines an importer as:
"Any natural or legal person established within the Union who places a device from a third country on the Union market."

Key responsibilities:

Importers under EU MDR have extensive obligations:

1. Verify manufacturer compliance:
- Ensure manufacturer is identified and registered in EUDAMED
- Verify existence of EU Declaration of Conformity
- Confirm device bears CE marking and required identification information
- Check that manufacturer has designated an Authorized Representative in EU
- Verify technical documentation exists and is accessible

2. Registration and identification:
- Register in EUDAMED database with importer details
- Ensure device is registered by manufacturer or Authorized Representative
- Add importer name, trade name, and address to device label (if not impractical)
- Provide contact details to facilitate communication with authorities

3. Storage and transport:
- Ensure storage and transport conditions do not compromise device compliance
- Maintain appropriate conditions to preserve device integrity
- Document storage and handling procedures

4. Post-market surveillance cooperation:
- Inform manufacturer and Authorized Representative of complaints and reports
- Cooperate with competent authorities in risk mitigation actions
- Immediately inform manufacturer of non-compliant or defective devices
- Keep register of complaints, non-conforming devices, recalls
- Provide samples and access to devices to competent authorities upon request

5. Documentation retention:
- Keep copy of EU Declaration of Conformity accessible
- Maintain information on devices placed on market
- Retain records for required period (typically matching device lifetime + 10 years for Class III implantables)
- Make documentation available to authorities upon request

6. Market surveillance:
- Monitor devices placed on market through importer
- Report serious incidents and field safety corrective actions
- Cooperate with manufacturer in field safety corrective actions
- Withdraw non-compliant devices from market when necessary

7. Traceability:
- Maintain records enabling identification of:
- Economic operator who supplied device to importer
- Economic operators to whom importer supplied device
- Provide traceability information to competent authorities upon request
- Implement systems to ensure full supply chain visibility

When importer obligations apply:

• Device manufactured outside European Union
• Importer places device on EU market for first time
• Device does not yet have legal presence in EU through manufacturer's Authorized Representative
• Importer is established (has legal presence) within EU

Importer vs. Authorized Representative:

Importer:
- Takes possession of devices and places them on market
- Supply chain and distribution role
- Responsible for compliance of devices they import
- Must verify manufacturer compliance before importation

Authorized Representative:
- Designated by manufacturer to act on their behalf
- Does not take possession of devices
- Facilitates communication with EU authorities
- Ensures manufacturer compliance with EU MDR

Both roles can exist simultaneously for same device from third country manufacturer.

USA FDA importer requirements:

Definition and role under FDA regulations:

Under US regulations, an importer is:
"Any person who imports or offers for import a medical device into the United States."

Key responsibilities:

1. FDA registration:
- Foreign manufacturers must register with FDA (even if not in US)
- US agents must be designated by foreign manufacturers
- Importers should verify manufacturer's FDA establishment registration
- Initial importers may need to register as "initial distributers"

2. Import entry filing:
- File entry documents with US Customs and Border Protection (CBP)
- Provide Prior Notice for imported FDA-regulated products (if applicable)
- Include FDA Product Code, manufacturer information, intended use
- Pay applicable user fees

3. Compliance verification:
- Ensure device complies with FDA requirements (510(k), PMA, De Novo clearance)
- Verify device is manufactured in registered establishment
- Confirm labeling meets FDA requirements (English language, adequate directions)
- Check for FDA import alerts or detention orders

4. Automated Commercial Environment (ACE):
- Use ACE system for entry filing and FDA review
- Provide required data elements for FDA screening
- Respond to FDA questions or requests for samples

5. FDA admissibility determination:
- FDA reviews entry and determines admissibility
- "May Proceed" - device can enter US commerce
- "Refused" - device violates FDA regulations, must be exported or destroyed
- Address any FDA observations or deficiencies

6. Record retention:
- Maintain import entry documents
- Keep records of device shipments and distribution
- Ensure traceability through US supply chain
- Make records available to FDA during inspections

7. Post-market requirements:
- Report adverse events through MedWatch (if applicable)
- Cooperate with manufacturer in recalls and corrections
- Comply with tracking requirements for tracked devices
- Participate in post-market surveillance studies if required

Common import challenges:

EU challenges:
- Complexity of EUDAMED registration and data requirements
- Language requirements for labeling and instructions (all official EU languages for country of placement)
- Understanding when Authorized Representative is sufficient vs. importer obligation
- Coordinating post-market surveillance across multiple EU countries
- Managing transition period requirements and deadlines

USA challenges:
- Navigating FDA Product Classification and determining regulatory pathway
- Ensuring foreign manufacturer FDA registration is current
- Responding to FDA import refusals and detention
- Compliance with unique US labeling requirements
- Understanding when devices are subject to import alerts

Regulatory consequences of non-compliance:

EU MDR:
- Competent authorities can prohibit or restrict device availability
- Withdrawal or recall orders
- Fines and penalties under national laws
- Criminal liability in some jurisdictions for safety violations
- Reputational damage and loss of market access

FDA:
- Import refusal and detention at border
- Warning letters and consent decrees
- Injunctions preventing future imports
- Criminal prosecution for willful violations
- Debarment from importing FDA-regulated products

Best practices for importers:

Due diligence:
- Thoroughly vet foreign manufacturers before importing
- Verify regulatory clearances and certifications
- Conduct audits of manufacturer quality systems when feasible
- Establish clear contractual obligations with manufacturers

Documentation:
- Maintain comprehensive records of all import transactions
- Organize documentation for quick retrieval during authority requests
- Implement document management systems for compliance evidence
- Regularly update records as regulations evolve

Regulatory intelligence:
- Stay current with FDA and EU MDR requirements
- Monitor import alerts, safety communications, regulatory updates
- Engage regulatory consultants or legal counsel when needed
- Participate in industry associations for knowledge sharing

Quality systems:
- Implement quality management systems aligned with ISO 13485
- Define procedures for receiving, inspecting, storing, and distributing devices
- Train staff on regulatory requirements and compliance obligations
- Conduct internal audits of import processes

Communication:
- Establish clear communication channels with manufacturers and Authorized Representatives
- Develop response plans for safety issues, recalls, authority inquiries
- Maintain updated contact information in regulatory databases
- Foster collaborative relationships with competent authorities

Importers play a vital role in global medical device supply chains, serving as the regulatory bridge that ensures devices from international manufacturers meet local safety and performance requirements before reaching patients and healthcare providers.