Importers or Distributors: Who is Responsible for Medical Device Compliance?
Written by: Manuel Mateos CEO and Regulatory Affairs Director, CMC Medical Devices & Drugs S.L.
Importer vs. Distributor: What’s the Regulatory Difference?
Importer Responsibilities
- Ensure the device complies with MDR/IVDR regulations.
- Verify that the product is CE marked and supported by proper technical documentation.
- Confirm that storage and transport conditions meet regulatory standards.
- Maintain a record of complaints, non-conforming products, and corrective actions.
Distributor Responsibilities
- Ensure the device bears the CE mark and includes the Declaration of Conformity.
- Check that all manufacturer-provided instructions and labeling are correct.
- Store and transport products under safe and compliant conditions.
- Manage complaints and coordinate with manufacturers or importers as needed.
Why Is It Important to Understand These Differences?
Fully understanding the distinct roles of importers and distributors helps stakeholders:
- Navigate MDR/IVDR compliance with greater clarity.
- Avoid regulatory pitfalls and ensure faster market access.
- Reduce liability by adhering to role-specific responsibilities.
Being well-informed allows you to tackle regulatory complexities with confidence, ensuring that your medical devices meet all necessary requirements to operate safely and compliantly in the EU.
Do You Have Questions or Need More Information?
We’re here to support you and provide the answers you need to overcome your regulatory challenges. Contact us today to speak with an EU compliance expert.
