In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.
Because medical devices such as medical gloves, surgical masks, intensive care equipment and other medical equipment play a crucial role within the context of the COVID-19 pandemic, on 24 April 2020, the application date of various provisions of the European Regulation (Regulation 2017/745) on medical devices was postponed until 26 May 2021.
Coronavirus: updated Belgian directive for the reuse of surgical and FFP2/FFP3 face masks during the COVID-19 pandemic
The national directive published on 07.04.2020 concerning the reprocessing of surgical and FFP2/3 face masks has been updated. This directive aims to guide the validation of the various initiatives being put in place regarding the reuse of surgical masks and personal facial protection.
In order to help healthcare professionals and support hospitals in their processes, the FAMHP is publishing guidelines on changing consumables (filters, etc.) used in the ventilation of COVID-19 patients.
In order to assist those offering alternative methods of producing medical devices, the FAMHP has developed guidelines which will help guarantee patient safety and the performance of the products used.
Belgian manufacturers of COVID-19 tests for professional use and Belgian authorised representatives of foreign manufacturers must notify the FAMHP when placing their tests on the market. This notification does not constitute an offer of equipment to the Belgian state. Companies wishing to offer tests to the government must contact the FPS Public Health.
An Alternative Test Protocol (ATP) has been developed for surgical face masks that do not have the necessary declarations, certificates and test reports. In the event of a positive result, this protocol still allows them to be used as a surgical mask or comfort mask. Test results are now also made public.
Coronavirus: national guideline for the management of clinical investigations for medical devices during the coronavirus pandemic
The national guideline has been developed to assist sponsors of clinical investigations for medical devices in the management of these investigations in the context of the coronavirus pandemic.
The FAMHP inspection services have noted that the surgical face masks offered do not have the declarations, certificates and test reports necessary according to European or international standards. For this reason, an Alternative Test Protocol (ATP) has been developed to ensure they can still be permitted for use as a surgical mask or comfort mask.
Coronavirus: measures taken by the FAMHP and relevant partners to continue to guarantee oxygen supplies
Due to the COVID-19 pandemic, there is an increased need for oxygen in Belgium for patients with respiratory problems. The FAMHP and its relevant partners, assembled as part of the Task Force in charge of the management of medical devices and medicinal products, are taking measures to guarantee supply.