Who Is a Distributor According to MDR and IVDR?
A distributor is any economic operator who makes a medical device or IVD available on the EU market without being its manufacturer, importer, or authorized representative. This role is typically filled by wholesalers, logistics operators, local suppliers, and commercial platforms involved in distributing medical devices. Distributors are independent entities but are obliged to comply with the conformity and surveillance requirements specified in MDR/IVDR and the national Medical Devices Act.
Responsibilities of Distributors of Medical Devices
Article 14 of MDR and IVDR clearly defines the responsibilities of distributors. These include:
- Verifying that the product bears CE marking, a valid UDI code, and complies with MDR/IVDR,
- Ensuring the presence of an EU Declaration of Conformity and completeness of the instructions for use,
- Maintaining appropriate transportation and storage conditions according to the manufacturer’s requirements,
- Registering and forwarding complaints, claims, and suspected non-compliances,
- Cooperating in corrective actions, product recalls, and communication with authorities.
Distributors must also verify that the manufacturer and importer data align with registration data in EUDAMED and that the SRN is assigned to the correct product.
Label and Documentation Checks – Operational Obligation
Distributors are required to regularly check that every product complies with labeling and documentation requirements:
- The label must match the technical documentation and include the manufacturer’s data,
- Instructions for use must be available in the language of the country of distribution,
- The UDI code must be verifiable and linked to the Declaration of Conformity.
Labeling non-conformities, missing instructions, or incorrect UDI may require halting distribution and reporting an incident to the manufacturer and authorities.
Distribution and Storage Conditions
Distributors must ensure that products are stored and transported under conditions compliant with MDR and the manufacturer’s specifications:
- Monitoring temperature and humidity (where applicable),
- Using FIFO or FEFO systems for products with expiration dates,
- Protection from damage, contamination, or unauthorized access.
These practices should be part of Good Distribution Practice (GDP) for medical devices and integrated with the ISO 13485 quality system.
Vigilance – Distributor’s Role in the Surveillance System
Distributors are an active link in the Vigilance and PMS systems and must promptly:
- Forward complaints and incident reports to the manufacturer,
- Collaborate in corrective actions and FSCA,
- Support the implementation of Vigilance procedures through documentation and monitoring.
This includes assisting with PMS activities such as logging user feedback, technical issues, and potential risks.
Complaint Recordkeeping and Information Sharing
Distributors must maintain a complete registry of:
- User, institution, and patient complaints,
- Quality issues and claims,
- Corrective actions and market withdrawals.
These records must be made available upon request to the manufacturer, authorized representative, importer, and competent authorities.
Liability and Penalties for Non-Compliance
Distributors bear administrative and civil liability for non-compliance. Penalties include:
- Fines of up to PLN 5,000,000,
- Mandatory product withdrawal and disposal,
- Civil liability towards users and healthcare providers.
Failure to meet obligations under Article 14 MDR/IVDR may result in losing authorized distributor status in the manufacturer’s network.
Common Operational Non-Conformities of Distributors
The most frequent issues identified during audits and inspections include:
- Distributing products based on outdated declarations of conformity,
- Lack of knowledge about significant design changes,
- Improper storage or transport conditions,
- Failure to respond to user complaints or incident reports.
Often, operational staff lack documented training on MDR and IVDR requirements.
How Pure Clinical Supports Distributors in Achieving Compliance
The Pure Clinical team offers full support to distributors in implementing and monitoring operational compliance:
- Development and implementation of MDR/IVDR-compliant procedures,
- Building complaint, PMS, and Vigilance registries,
- Documentation verification – declarations of conformity, labeling, instructions,
- Training for operational and quality personnel,
- Operational readiness audits and support during URPL inspections.
FAQ
Can a distributor supply devices directly to end-users or patients?
Is it legal for a distributor to modify product labelling or transport packaging?
How often should a distributor verify CE marking and UDI compliance?