Import services

Eumed® offers a comprehensive service for managing regulatory, administrative, technical, and legal issues related to the import, market placement, and post-market surveillance of medical and in vitro diagnostic devices from non-EU countries.

As a European Authorized Representative (EU Representative), Eumed® ensures that imported products comply with the requirements set by European Regulations (EU) 2017/745 and 2017/746, supporting manufacturers and importers at every stage—from technical documentation to post-market surveillance.

Thanks to our experience, we can help companies optimize import processes, logistics and quality management, reducing risks and ensuring regulatory compliance.

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Services for importers and manufacturers outside the EU

Importing medical devices from non-EU countries comes with specific legal and operational responsibilities for those seeking to introduce products to the European market. To address these challenges, Eumed® provides comprehensive support including:
  • Legal and Regulatory Representation: Acting as the importer to ensure full regulatory compliance and protect distributors from direct liability.
  • Document Management and Compliance: Verifying technical documentation and assisting with registration on EUDAMED.
  • Monitoring and Surveillance: Managing market recalls and facilitating communication with EU Competent Authorities.
  • Optimization of Logistics and Financial Resources: Distinguishing the roles of distributor and importer to reduce financial risk and enhance inventory management.
Eumed® is a EU representative

In its role as a European Authorized Representative, Eumed® serves as the official liaison between non-EU manufacturers and European authorities, ensuring:

  • Verification of Technical Documentation and Regulatory Compliance: Thorough review and validation of all necessary documentation.
  • EUDAMED Registration: Handling the registration of manufacturers and their devices in the European database.
  • Post-Sale Surveillance and Inspection Management: Continuous monitoring to maintain compliance with regulatory standards.
  • Official Point of Contact for EU Competent Authorities: A dedicated channel for all official communications.

    This service is essential for non-EU manufacturers aiming to market their products in Europe without establishing a physical presence in the Union.

Support tools for manufacturers and importers

Eumed® offers innovative solutions to ensure efficient and compliant management of medical devices:
FTE – Electronic Technical File

A digital platform for managing technical documentation in accordance with Regulation (EU) 2023/988.

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Clinical investigations

Comprehensive support in organizing clinical trials that meet European standards.

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Identification and Traceability

Assistance with implementing the Unique Device Identification (UDI) system, as required by Regulation (EU) 2017/745, to ensure complete traceability of devices.

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Eumed® offers strategic and operational support to facilitate entry into the European market, including:
  • Market Analysis: Evaluating the commercial potential of your products.
  • Ricerca di distributori e partner locali per la vendita in Europa.
  • Gestione assicurativa per coperture di responsabilità civile.
  • Facility Logistics: Ensuring safe storage and transportation of devices.
  • Surveillance and Post-Market Support: Providing ongoing monitoring to maintain security and regulatory compliance.

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Discover how Eumed® can support your business in import and marketing of medical devices, in vitro diagnostics, medical devices and biomedical products in Europe.

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