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February 1, 2026
Approximately 5 minutes
Belgian Regulations for In-House Manufactured Medical Devices in Health Institutions
Belgian Regulations for In-House Manufactured Medical Devices in Health Institutions
1. Definition and Scope
'In-house' devices are medical devices or in vitro diagnostic medical devices (IVDs) manufactured and used only within health institutions, without transfer to another legal entity. They are governed by Article 5(5) of Regulation (EU) 2017/745 (MDR) for medical devices and Article 5(5) of Regulation (EU) 2017/746 (IVDR) for IVDs. Source: FAMHP Health Institutions and Healthcare Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_healthcare
2. Conditions for Manufacture and Use
Health institutions must comply with specific requirements:
- Appropriate quality management system in place.
- Justification that patient needs cannot be met by equivalent market devices.
- Documentation on manufacturing process, design, and performance.
- Publicly available declaration with institution details and device information.
- Review of experience gained from clinical use.
- Not manufactured on an industrial scale.
For IVDs, additional requirements include compliance with EN ISO 15189 or equivalent accreditation. National prohibitions apply: implantable devices and those emitting ionizing radiation cannot be in-house manufactured. Source: FAMHP Health Institutions and Healthcare Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_healthcare
3. Declaration and Publication Process
A mandatory declaration must be published via the FAMHP web portal, including:
- Institution name and address.
- Device identification, description, and classification.
- Statement of compliance with Annex I requirements (with justifications for deviations).
Declarations are validated by FAMHP and publicly accessible. Updates require re-submission and re-validation. Source: FAMHP Health Institutions and Healthcare Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_healthcare
4. Vigilance Obligations
Incidents involving in-house devices must be reported to FAMHP via Vigilance.meddev@afmps.be. Corrective actions are also required. Source: FAMHP Health Institutions and Healthcare Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_healthcare
5. Guidance and Resources
European guidance (MDCG 2023-1) and FAMHP Q&A on in-house IVDs are available. For questions, contact info.meddev@afmps.be. Source: FAMHP Health Institutions and Healthcare Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_healthcare
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