Distributor

A Distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a medical device available on the market up until the point of putting into service. Distributors play a crucial role in the medical device supply chain and have specific regulatory obligations.

Key responsibilities under EU MDR:
- Verify manufacturer has appropriate documentation
- Verify device has required CE marking and labeling
- Verify device is accompanied by required information
- Store devices under appropriate conditions
- Maintain traceability of devices they supply
- Report incidents and non-compliant devices to authorities
- Cooperate with authorities on corrective actions
- Register in EUDAMED database

Storage and transport requirements:
- Maintain proper temperature and humidity conditions
- Protect devices from damage during storage
- Follow manufacturer's storage instructions
- Ensure proper handling during distribution
- Maintain cold chain for temperature-sensitive devices

Verification obligations:
Before making device available, distributor must verify:
- Device has CE marking affixed
- Device is accompanied by required EU Declaration of Conformity
- Device has instructions for use and safety information
- Manufacturer and authorized representative are identified
- Device labeling is in language understood by users
- UDI information is present (where applicable)

When distributor becomes a manufacturer:
Under EU MDR Article 16, a distributor is deemed a manufacturer if they:
- Place device on market under their own name/trademark
- Change the intended purpose of a device
- Modify a device in a way that may affect compliance

Traceability requirements:
- Maintain records of suppliers and customers
- Record device names, models, and batch/serial numbers
- Keep records for period specified by regulation (minimum 10 years for implantables)
- Provide information to authorities upon request
- Enable device recalls and field safety corrective actions

USA FDA requirements for distributors:
Under FDA regulations:
- Must comply with FDA Device Tracking requirements (for certain devices)
- Report adverse events if they become aware (Medical Device Reporting)
- Maintain complaint files
- Follow FDA's Medical Device Reporting (MDR) requirements
- May need establishment registration for certain activities

Due diligence obligations:
Distributors must exercise due diligence to ensure:
- They deal with legitimate manufacturers and suppliers
- Products are genuine and not counterfeit
- Devices have not been subject to recalls unless authorized
- Storage and transport conditions comply with requirements
- Documentation is complete and authentic

Incident and vigilance reporting:
Distributors must:
- Immediately inform manufacturer and authorities of serious incidents
- Report devices suspected of non-compliance
- Keep record of complaints and device returns
- Cooperate in post-market surveillance activities
- Provide samples or access to devices when requested

Common challenges for distributors:
- Ensuring proper cold chain for temperature-sensitive devices
- Maintaining traceability across complex supply chains
- Verifying authenticity of products and suppliers
- Keeping up with regulatory changes
- Managing product recalls efficiently
- Handling devices from multiple manufacturers with different requirements

Best practices:
- Implement quality management system for distribution activities
- Regular training on regulatory requirements
- Automated systems for traceability and record-keeping
- Strong supplier qualification processes
- Clear procedures for incident reporting
- Regular audits of storage and transport conditions

Distributors are essential economic operators in the medical device ecosystem, ensuring devices reach healthcare providers and patients while maintaining safety, quality, and regulatory compliance throughout the supply chain.