Use of medical devices and in-vitro diagnostics (IVD)

In principle, manufacturers are responsible for the flawless quality and conformity of their medical devices and IVDs. Accordingly, the healthcare facilities that purchase the medical devices / IVDs have a considerable responsibility with regard to the choice of suppliers and medical devices / IVDs. Only medical devices / IVDs bearing a valid conformity mark (CE or MD mark) may be used. Furthermore, the manufacturer's instructions, such as the instructions for use and the following duty of care, must be observed during use and storage.

Anyone handling medical devices / IVDs must take all measures that are necessary according to the state of the art in science and technology to ensure that health is not endangered (Art. 3 HMG).

Reporting incidents

Any healthcare professional who discovers a serious incident during the use of medical devices / IVDs must report this to the supplier and the competent authority. Further information: Reporting incidents & FSCA (Vigilance).

Products for injection

Devices for injection that are intended to remain in the human body for longer than 30 days (extended-release devices) may only be used by a doctor or by qualified nurses with appropriate training in the injection of extended-release devices under the direct supervision and responsibility of a doctor (Art. 70 para. 2 and 3 and Annex 6 MedDO).