Central traceability register: the traceability of certain implants to become compulsory

From 1 May 2021, notification of the insertion or removal of implants will become compulsory for the implants listed in the annex to the Royal Decree of 27.09.2020 relating to the Central Traceability Register (RCT in French). This notification was already possible (but not compulsory) for all implants since 2014.

What is the Central Traceability Register (RCT)?
The RCT is a system that centralises notifications of an insertion or removal of implants. It was developed as part of the "Traceability of Implantable Medical Devices" programme. This programme was launched by the Minister of Public Health as the information that had hitherto been recorded on implantable medical devices used in Belgium was not sufficient to ensure full traceability, and also to be able to react quickly and adequately in the event of an incident. One of the main objectives of the RCT is therefore patient safety.

How is the RCT updated and who can consult it?
The RCT is updated by health professionals. Every patient can use it to consult the list of their implants. In association with other applications of the FAMHP, the RCT makes it possible to improve the traceability of implants distributed, prescribed, dispensed, implanted and removed in Belgium, while offering greater transparency for the patient.

The RCT also enables the FAMHP to take the necessary actions with the relevant actors in the event of a major incident with an implant.

Is the data of the RCT protected?
Particular consideration has been given to the security of encrypted data. Notifications are encrypted end-to-end and patient data is also stored in encrypted form. Moreover, the consultation of these data is controlled, by verifying whether there is a therapeutic relationship between the health professional and the patient.  

How to access the RCT?

  • For private clinics

An online application can be accessed via a web browser, by logging in with an eID reader or via itsme® (click on "Professionnels de la santé" (Healthcare Professionals) and select "RCT" in the list of online services).

In order to consult the register or to submit a notification of implant or removal of an implant, the health professional must have a therapeutic relationship with the patient. The online application is also accessible to administrative staff who can pre-complete the notification. The health professional must then validate the notification.

  • For hospitals

The RCT Web Service is an automated system ("machine to machine"). However, the integration of the service into the IT system of the hospital requires a technical constraint: the development of a connector specific to the hospital. More information (available in Dutch or French).

  • For patients

The patient can connect to the online application, which is accessible via a web browser, by logging in with an eID reader or via itsme® (then click on "implants"). The patient can consult all notifications of implants and/or removal of implants concerning them. They can also download their patient card. This card shows all notifications on a single document.

What data is not included?
As the notification of the insertion or removal of implants is only compulsory for implants listed in the annex to the Royal Decree of 27.09.2020 on the Central Traceability Register as from 1 April 2021, certain notifications prior to this date or concerning implants not included in the list may not be included.

Last updated on
07/10/2020