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February 1, 2026
Approximately 5 minutes
Belgian Regulations for In-House Medical Device Software in Health Institutions
Belgian Regulations for In-House Medical Device Software in Health Institutions
1. Qualification as Medical Device Software
Software qualifies as a medical device if it has a medical purpose and is intended for individual patients, either standalone or in combination with other devices. It does not qualify if it merely stores, archives, communicates data, or performs simple searches without a specific medical purpose (e.g., administrative tools). Examples of qualifying software include tools for diagnosis, treatment support through data analysis, medical imaging processing, or AI for prognosis prediction. This applies to standalone software, plug-ins, APIs, and software controlling medical equipment. Refer to MDCG 2019-11 for detailed guidance. Source: FAMHP In-House Medical Software Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_5
2. In-House Exception under Article 5(5) MDR/IVDR
Health institutions may manufacture and use in-house medical device software under the Article 5(5) exception if all conditions are met:
- Fully manufactured within the institution (design, production, quality control).
- Complies with Annex I general safety and performance requirements.
- Appropriate quality management system implemented (see MDCG 2023-1, chapter 3.5).
- Addresses target patient group needs not met (or not met adequately) by equivalent market devices.
- Not transferred to another legal entity (in hospital networks, per Circular 655).
- Public declaration with institution details and device information.
- Documentation on manufacturing, design, and performance.
- Review of clinical use experience and corrective actions.
- For IVDR class D devices: specific documentation requirements.
- IVDs: Laboratory accreditation to EN ISO 15189 or equivalent.
Failure to meet conditions requires full MDR/IVDR compliance as marketed devices. Source: FAMHP In-House Medical Software Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_5
3. Registration and Declaration
Institutions must register via the FAMHP web portal, providing:
- Institution name and address.
- Device identification, description, EMDN code, classification, and intended use.
- Declaration of Annex I compliance (with justifications for deviations).
FAMHP validates submissions; successful validation generates the declaration automatically. Source: FAMHP In-House Medical Software Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_5
4. Vigilance Reporting
Serious incidents or field safety corrective actions involving in-house software must be reported to FAMHP at vigilance.meddev@fagg-afmps.be. Source: FAMHP In-House Medical Software Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_5
5. Additional Resources
- MDCG 2019-11: Guidance on qualification and classification of software.
- MDCG 2023-1: Guidance on in-house devices.
- Q&A on in-house IVDs and Circular 655 available on FAMHP site. Source: FAMHP In-House Medical Software Page https://www.famhp.be/en/human_use/health_products/medical_devices_and_their_accessories/health_institutions_and_5
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