Healthcare institutions often develop their own software to support patient care. This software has to comply with the legal requirements and obligations described below.
When is software considered a medical device?
Software is considered a medical device if it has a medical purpose in itself and is used for individual patients. It can be used alone or in combination with other medical devices.
Software that only stores, shares, archives data or performs simple searches, is not covered by Regulation (EU) 2017/745 medical device (Medical Device Regulation, MDR) or Regulation (EU) 2017/746 in vitro diagnostic medical device (In Vitro Diagnostic Regulation, IVDR). Nor is this the case for software without a specific medical purpose, such as administrative tools for example. Once the software performs an action on data that goes beyond these basic functions, it does qualify as a medical device. This includes for example software that helps diagnose diseases, software that analyses patient data to support treatments, or software that processes medical imaging.
Please refer to the European guidance document MDCG 2019-11 for more information.
It is important to consider software in a broad context. This means that stand-alone software, plug-ins, application programming interfaces (APIs), as well as software that controls medical equipment, can all qualify as medical devices.
What is in-house medical device software?
To qualify as in-house medical device software, the software must first qualify as a medical device.
Health institutions can use the exception rule described in Article 5(5) of the MDR/IVDR to manufacture and use in-house medical devices and in-house medical device software only if they meet the requirements set out in that article (more information).
Registration of in-house medical devices
Article 5(5)(e) of the MDR/IVDR requires health institutions to draw up a declaration, which it must make publicly available, for the in-house medical devices they manufacture and use. The Royal Decree of 12 May 2021 and the Royal Decree of 14 September 2022 list the items to be described in that declaration:
1. The identification of the device within the health institution.
2. The description of the device.
3. The EMDN code referred to in Article 26 of MDR/Article 23 of IVDR.
4. The classification of devices based on Annex VIII of MDR/IVDR.
5. The intended use of the device.
This information must be registered using the FAMHP web portal. A "declaration of manufacture" will be automatically generated and published.
Serious incidents and/or corrective actions with regard to in-house devices should be reported to the FAMHP via vigilance.meddev@fagg-afmps.be. For more information, please refer to the webpage 'Notifications d'incidents avec des dispositifs médicaux' (webpage only available in Dutch and French).
Seminar 2026
A seminar on 'in-house medical devices' will be held early 2026 in cooperation with the FPS Public Health. This seminar will provide a more in-depth explanation of the requirements of Article 5(5) for in-house medical devices and in-house medical device software and there will also be an opportunity to ask questions. As soon as the exact date and location are known, this information will be shared with all Belgian health institutions.
Would you like to be kept informed? Then register using this link: Save the date 'Seminar In-house Medical Devices 2026'.
More information
Webpage: In-house medical software: registration and legislation