On 10 March 2026, the Federal Agency for Medicines and Health Products is organising a study day on in-house developed medical software for healthcare institutions. For this event, the FAMHP receives support from both the FPS Public Health, Food Chain Safety and Environment and the National Institute for Health and Disability Insurance.
Update 30 January 2026: The study day is fully booked. If you would like to be placed on the waiting list, please send an email to: In-house-software-event@fagg-afmps.be.
On 10 March 2026, the FAMHP, with the support of the FPS Public Health and the NIHDI, is bringing healthcare institutions together during a study day entirely dedicated to in-house developed medical software.
This study day is aimed at medical software developers, researchers and IT managers in healthcare institutions who are involved in the development, management or implementation of internally developed medical software.
Healthcare institutions are increasingly developing their own software to support diagnostics, monitoring, clinical decision-making and care processes. Digitalisation, data-driven applications and artificial intelligence play an increasing role in this.
These developments offer new opportunities to improve healthcare processes and integrate innovative applications. However, the question remains how healthcare institutions can develop and deploy their medical software in a well-considered, secure and future-proof manner.
With this study day, the FAMHP wants to support healthcare institutions in making informed choices, focusing on patient safety, quality and compliance with European regulations.
Programme
Morning - Qualification and regulation
- Introduction: Professor Pascal Verdonck (Belgian Association of Hospital Managers, BAHM)
- Qualification of medical software as a medical device or in vitro diagnostic medical device: Koen Cobbaert (COCIR / Philips)
- MDR / IVDR, consistency with other digital legislations (AI Act, European Health Data Space, cybersecurity ...): Stef Rommes (VITO)
Afternoon - Pathways for in-house developed medical software
- Explanation for each pathway
- Scope
- Obligations
- Practical points of attention and bottlenecks
- CE certification: Thomas Doerge (BSI - notified body)
- Clinical studies: Benedict Nuytens (FAMHP)
- In-house exemption: Christophe Driesmans (FAMHP)
- Closing moment and reflection from different perspectives
Practical information
Date: 10 March 2026
Time: 9.00 - 17.00 (reception from 8.30 a.m.)
Location: Galilee building, Avenue Galilée 5/03 – 1210 Brussels
Participation: free of charge
Language: English
Registration
Registration is mandatory.
Registration deadline: 27 February 2026.
Please register via the registration form (NL or FR).
Please note that the number of places is limited. Make sure you register in time.
Confirmation of participation will be sent via email.
Any information on accreditation points/credits will be communicated together with the final programme.