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February 1, 2026
Approximately 5 minutes
FAMHP Guidance for Distributors of Medical Devices in Belgium
FAMHP Guidance for Distributors of Medical Devices in Belgium
1. Introduction and Purpose
This general guide (version 2.1, dated 26 May 2021) is intended to assist distributors of medical devices, including in vitro diagnostic medical devices (IVDs), in understanding and fulfilling their obligations under Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). It aims to maintain quality and safety throughout the distribution chain. Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
2. Definition of Distributor
A distributor is 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 the point of putting into service (MDR Article 2(34); IVDR Article 2(45)). Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
3. General Obligations
Distributors must:
- Verify CE marking, EU declaration of conformity, labelling, and UDI assignment.
- Ensure storage and transport conditions comply with manufacturer instructions.
- Maintain a register of complaints, non-conforming devices, recalls, and withdrawals.
- Cooperate with manufacturers and authorities on corrective actions. Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
4. Registration Requirements
Distributors must register via the FAMHP web portal. Failure to register may result in administrative measures. Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
5. Vigilance and Market Surveillance
Distributors must:
- Forward complaints or incident reports to the manufacturer/authorised representative.
- Report serious incidents to FAMHP if the manufacturer is unavailable.
- Cooperate in field safety corrective actions (FSCAs). Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
6. Storage and Transport Conditions
Distributors must ensure conditions do not jeopardise device compliance, following manufacturer information. Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
7. Self-Checking Guide for Contribution Exemption
The guide includes a self-assessment checklist to determine if a distributor performs only basic activities (potentially exempt from annual contribution) or additional activities triggering further obligations. Compliant distributors with limited activities may be exempt from the annual fee. Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
8. Specific Rules for STHA (Service and Technical Home Assistance)
Additional considerations apply to entities providing installation, maintenance, or technical assistance at home. Source: Guidance for distributors of medical devices (version 2.1) https://www.famhp.be/sites/default/files/content/POST/MEDDEV/11%20STHA/Guidance%20distributors%20meddev%20famhp_general%20guide%20_ENG_version%202.1.pdf
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