Devices manufactured and used only within health institutions ('in-house' devices)

General information
Conditions for the manufacture and use of in-house devices
Publication of the declaration of manufacture of in-house devices
Vigilance
Guidance documents and Q&A

1. General information
Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic medical devices set out specific requirements for devices manufactured and used only within health institutions. These devices are commonly referred to as ‘in-house’ devices..

These in-house devices can only be manufactured and used under certain conditions, as detailed below.

2. Conditions for the manufacture and use of ‘in-house’ devices

2.1 Medical Devices

For medical devices, the following conditions, set out in Article 5(5) of Regulation 2017/745, apply:

the devices are not transferred to another legal entity.
manufacture and use of the devices occur under appropriate quality management systems.
the health institution justifies in its documentation that 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.
the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use.
the health institution draws up a declaration which it shall make publicly available, including
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 set out in Annex I of Regulation 2017/745 and, where applicable, information on which requirements are not fully met with a reasoned justification.
the health institution draws up documentation that makes it possible to have an understanding of
1. the manufacturing facilities,
2. the manufacturing process,
3. the design and performance data of the devices, including the intended purpose, and that sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to Regulation 2017/745 are met.
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in the previous paragraph.
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions
the devices are not manufactured on an industrial scale..

2.2 In vitro diagnostic medical devices

For in vitro diagnostic medical devices, the conditions are described in Article 5(5) of Regulation 2017/746:

the devices are not transferred to another legal entity.
manufacture and use of the devices occur under appropriate quality management systems.
the laboratory of the health institution is compliant with standard EN ISO 15189 or, where applicable national provisions, including national provisions regarding accreditation.
the health institution justifies in its documentation that 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.
the health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use.
the health institution draws up a declaration which it shall make publicly available, including
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 set out in Annex I and, where applicable, information on which requirements are not fully met with a reasoned justification
as regards class D devices in accordance with the rules set out in Annex VIII, the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I are met. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point 7.
the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions
the devices are not manufactured on an industrial scale.

2.3 National provisions

With regard to Article 5(5) of Regulation 2017/745, national measures have been taken in the Law of 22 December 2020 on medical devices (FR/NL) and in the Royal Decree of 12 May 2021 implementing the Law of 22 December 2020 on medical devices (FR/NL).

With regard to Article 5(5) of Regulation 2017/746, national measures have been taken in the Law of 15 June 2022 on in vitro diagnostic medical devices (FR/NL), the Royal Decree of 14 September 2022 implementing the Law of 15 June 2022 on in vitro diagnostic medical devices (FR/NL) and the Royal Decree of 25 September on performance studies for in vitro diagnostic medical devices (FR/NL).

2.4 Prohibitions
The manufacture and use of the following devices in health institutions as devices under Article 5(5) of Regulation 2017/745 is prohibited (Article 7§4 of the Law of 22 December 2020 on medical devices):
- implantable devices
- devices emitting ionizing radiation

3.Publication of the declaration of manufacture of in-house devices
Health institutions that manufacture devices that are used exclusively in their institution must draw up a declaration that includes the following information:

the name and address of the manufacturing health institution;
the details necessary to identify the devices;
1. the identification of the device within the health institution;
2. the description of the device;
3. the EMDN code (European Medical Device Nomenclature - see Article 26 of Regulation 2017/745 or Article 23 of Regulation 2017/746);
4. the classification of the device (based on Annex VIII of Regulation 2017/745 or Regulation 2017/746);
5. the intended use of the device;
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.

This 'declaration of manufacture' is mandatory since 26 May 2021 for in-house medical devices and since 26 May 2024 for in-house in vitro diagnostic medical devices. 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.

How do this in practice ?

Register your health institution in the web portal (in the application « my company »).
Register the activity or activities that you are carrying out (e.g. the manufacture of ‘in-house’ devices) in the web portal (in the application « my activities »).
To help you with these first two steps, you can consult the user manual (FR/NL) for the « my company y» and « my activities » applications.
Register your ‘in-house’ devices in the web portal (in the application « my devices » application) using one of the following two options :
To help you to fill in the various field correctly, whichever option you choose, you can consult the following instructions (FR/NL).
1. Notification by notification;
  To help you, you can consult the user manual dedicated (FR/NL) to this subject.
2. By a group of notification via a ‘bulk download’ with a CSV file. The CSV file template can be accessed directly from the «my devices» application. This ‘bulk download’ allows you to notify several new in-house devices and/or introduce several changes (after validation) in a single operation. Note: some errors are detected directly by the program before verification by the FAMHP. Please take this into account and correct your file before trying the upload again.
  To help you, you can consult the technical note dedicated to this subject.
Wait for your notifications to be checked by the FAMHP. You will receive an email telling you that the status of your notification(s) has/have changed. By logging back into the « my devices » application you can check whether your notifications have been validated or whether they require corrections requested by the FAMHP. Once validated, the public declaration of manufacture will be available on our web portal and accessible to all for each notification of manufacture of in-house device.
Keep your declarations up to date. If the declared data changes, enter the change(s) in the web portal either notification by notification or by group of notifications (see point 3 and associated documents). Your data will be checked again by the FAMHP.

4. Vigilance
Incidents and corrective actions that occur with in-house devices must be reported to FAMHP via the following address: Vigilance.meddev@afmps.be.

Rules concerning notification of incidents and corrective actions (type of incident, deadlines, forms, etc.) are available on the FAMHP website (FR/NL).

5. Guidance documents and Q&A

A European guidance document on in-house devices is available here. FAMHP has also produced a Q&A document for Belgian health institutions that manufacture and use in-house in vitro diagnostic medical devices. Further questions can always be sent to i nfo.meddev@afmps.be.