- General information
- Common specifications
- Notification on the FAMHP web portal
- Information to be provided with the reprocessed device
- Vigilance
1. General information
Regulation 2017/745 on medical devices and the Law of 22 December 2020 on medical devices provides for the possibility for health institutions to reprocess single-use devices for further use.
Only reprocessing of single-use devices that is considered safe according to the latest scientific evidence may be carried out.
These devices can only be reprocessed under certain conditions described in Article 17(3) of the Regulation. These conditions are for example:
- no transfer of devices to other institutions;
- the safety and performance of the reprocessed device must be equivalent to that of the original device;
- public declaration of conformity;
- the reprocessing must be performed in accordance with the common specifications and compliance with these common specifications must be certified by a notified body.
In Belgium, at the request of the health institution, devices are permitted to be reprocessed by an external reprocessing company. The reprocessed device must be returned in its entirety to the health institution and the external company must comply with the requirements of Article 17(3) of the Regulation.
Reprocessing of the following single-use devices is prohibited:
- devices emitting radiation and devices for their administration;
- devices used to administer cytostatic or radiopharmaceutical medicinal products;
- devices incorporating medicinal substances;
- devices with a risk of transmitting spongiform encephalopathies;
- implantable devices;
- devices with batteries that cannot be changed or present a risk of malfunctioning after reprocessing;
- devices with internal data storage necessary for their use and which cannot be changed or which present a risk of malfunctioning after reprocessing;
- devices with cutting or scraping blades, drills or components subject to wear that are no longer functional after the first use and cannot be changed or sharpened before the next medical procedure.
2. Common specifications
Health institutions reprocessing single-use medical devices must do so in accordance with the common specifications adopted by the European Commission in Implementing Regulation 2020/1207. Compliance with the common specifications is certified by a notified body. These common specifications have been adopted by the European Commission and published in the Official Journal of the European Union.
3. Notification on the FAMHP web portal
Health institutions that reprocess and use reprocessed single-use devices must notify FAMHP. This notification of the reprocessing of single-use devices is made via the FAMHP web portal, using the 'My devices' application.
The health institution must produce a notification for each device it reprocesses, using a form to be completed in the application. The following information is requested:
- UDI-ID of the initial device (if applicable);
- if applicable, the name, address and contact details of a contact person at the external reprocessor that reprocesses the devices;
- the name of the original manufacturer;
- the original trade name of the device;
- the description of the device;
- the download of the certificate issued by the notified body referred to in Article 17(5) of the Regulation;;
- the download of the declaration of conformity referred to in Article 5(5) e) of the Regulation.
This information is then published on the FAMHP internet portal and made public.
A user manual (FR/NL) beschikbaar.
4.Information to be provided with the reprocessed device
The following information must be indicated on the label and, if applicable, in the instructions for use of the reprocessed device:
- the name and address of the natural or legal person responsible for the reprocessing;
- an indication that the device in question is a single-use device that has been reprocessed;
- the number of reprocessing cycles already performed and any limitations as regards the number of reprocessing cycles;
- the name and address of the manufacturer of the original single-use device no longer appear on the label but are included in the instructions for use of the reprocessed device.
5. Vigilance
Incidents that occur with reprocessed devices should 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 )