The central traceability registry has been created based on the Royal Decree of 17/02/2015, which executes the law of 13/12/2013 regarding medical devices. This law obliges:
- Each distributor of medical devices on the Belgian market to register its devices at the FAGG.
- Each health professional in Belgium to register all implantations and explantations of medical devices at the FAGG.
The central traceability registry facilitates different stakeholders:
- Care providers can register the implantation or explantation, and consult the proof of notification of the vendor
- Patients can consult their implantations and can create a “patient card” containing the key information about their implants.
- FAGG agents can consult an anonymized view of all registered implantations and explantations; the FAGG authorised doctor can consult all registered implantations and explantations, including the NISS of the patient.
The registry started in 2014 as collaboration between the FAGG and Smals vzw. While the data collection from extra-muros care providers (using a web application) is going well, the central traceability registry currently faces some difficulties in receiving data from the hospitals. To overcome these difficulties, the FAGG is requesting to involve healthdata for the data collection from those hospitals that do not use the web service provided by Smals vzw (see also Annex 2).