In-house medical software: registration and legislation

  1. When is software considered a medical device?
  2. What is in-house medical device software?
  3. Registration of in-house medical devices
  4. Vigilance
  5. More information

 

  1. 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 on medical devices (Medical Device Regulation, MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (In Vitro Diagnostic Regulation, IVDR), nor is any 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 qualifies 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.

Examples:

  • Software that analyses medical imaging to detect tumours.
  • Components within digitised patients' files that assign priorities or colour codes to patients based on calculations with patient data.
  • Apps that actively monitor and analyse patients' physiological parameters.
  • Software that uses artificial intelligence to predict prognoses regarding certain conditions based on patient data.

 

  1. 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).

Terms and requirements for in-house software:

  • The device must be manufactured within the health institution itself. The health institution is in charge of design, production and quality control.
  • The device must meet the general safety and performance requirements set out in Annex I of MDR/IVDR.
  • The devices are manufactured and used in accordance with an appropriate quality management system. More information can be found in chapter 3.5. of MDCG 2023-1.
  • The target patient group's specific needs cannot be met, or cannot be met at the appropriate level of performance by an equivalent device available on the market.
  • In-house medical devices shall not be transferred to another legal entity. In the context of typical Belgian hospital networks, this is interpreted as described in Circular 655 (Fr/Nl).
  • A declaration must be drawn up containing the following information: name and address of the health institution, the details necessary to identify the devices, a declaration that the devices meet the safety and performance requirements set out in Annex I (see comment below on registration).
  • Documentation must also be drawn up that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the in-house devices to enable the competent authority to ascertain that the requirements set out in Annex I of MDR/IVDR are met (this requirement only applies to class D devices when it comes to IVDR).
  • The health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
  • Only applicable to IVDR: the laboratory of the health institution is compliant with standard EN ISO 15189 or, where applicable, with national provisions, including national provisions regarding accreditation.

If a health institution fails to demonstrate that the above-mentioned conditions are met, but the product or software is classified as a medical device, the medical devices in question are not covered by the exception rules set out in Article 5(5) of MDR/IVDR and thus will have to meet the full requirements of MDR/IVDR like any other device available on the market.

 

  1. Registration of in-house medical devices

Article 5(5)(e) of the MDR and Article 5(5) f) of the IVDR require health institutions to draw up a publicly available declaration for the in-house medical devices they manufacture and use that includes the following information :

  1. The name and address of the manufacturing health institution;
  2. The details necessary to identify the devices;
  3. A declaration that the devices meet the general safety and performance requirements (see Annex I of Regulation 2017/745 or Regulation 2017/746) and, where applicable, information on which requirements are not fully met with a reasoned justification.

The Royal Decree of 12 May 2021 and the Royal Decree of 14 September 2022 describe the details necessary to be provided in this declaration to identify the devices (referred to in point 2 above):

  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.

To draw up this declaration, the health institution must use the FAMHP web portal. To do this, the health institution registers the above-mentioned data on this portal. After validation by the FAMHP, the ‘declaration of manufacture’ is automatically generated. No additional separate declaration is required from the health institution. For more information on the concrete steps, see point 3 on the general in-house devices page.

  1. Vigilance

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).

 

  1. More information
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