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February 2, 2026
Approximately 5 minutes
Belgian eHealth Guidance on Distribution of Medical Devices
Belgian eHealth Guidance on Distribution of Medical Devices
1. Purpose and Scope
This document provides guidance on the distribution of medical devices in Belgium, focusing on obligations for distributors under the MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746). It covers registration, verification of conformity, storage conditions, vigilance reporting, and the use of the WebMEDSEIP portal. Source: Distribution Guidance https://www.vas.ehealth.fgov.be/webmedseip/en/documents/distribution.pdf
2. Definition of Distributor
A distributor is defined as any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market up until putting into service. Source: Distribution Guidance https://www.vas.ehealth.fgov.be/webmedseip/en/documents/distribution.pdf
3. Registration Requirements
Distributors must register in the WebMEDSEIP portal operated by eHealth. Registration is mandatory for all economic operators involved in distribution activities. Source: Distribution Guidance https://www.vas.ehealth.fgov.be/webmedseip/en/documents/distribution.pdf
4. Key Obligations
Distributors must:
- Verify CE marking, declaration of conformity, labelling, and UDI.
- Ensure appropriate storage and transport conditions.
- Maintain records of complaints, non-conforming devices, recalls, and withdrawals.
- Cooperate with manufacturers and authorities on corrective actions. Source: Distribution Guidance https://www.vas.ehealth.fgov.be/webmedseip/en/documents/distribution.pdf
5. Vigilance and Reporting
Distributors are required to forward incident reports to the manufacturer and, if necessary, report serious incidents to FAMHP. Source: Distribution Guidance https://www.vas.ehealth.fgov.be/webmedseip/en/documents/distribution.pdf
6. Annual Contribution and Self-Check
The document includes information on annual contributions and a self-checking tool to determine if distributors qualify for exemption based on limited activities. Source: Distribution Guidance https://www.vas.ehealth.fgov.be/webmedseip/en/documents/distribution.pdf
7. Contact and Additional Resources
For questions, contact relevant FAMHP or eHealth services. Additional guidance is available on the FAMHP website. Source: Distribution Guidance https://www.vas.ehealth.fgov.be/webmedseip/en/documents/distribution.pdf
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