Application of medical devices and in vitro diagnostic medical devices (IVD)

The manufacturers are basically responsible for the flawless quality and conformity of their medical devices and IVDs. Accordingly, the healthcare institutions procuring the medical devices / IVDs bear considerable responsibility in their selection of suppliers and medical devices / IVDs. Only those medical devices / IVDs that bear a valid conformity marking (CE mark or MD mark) may be used. When using and storing the product, the information provided by the manufacturer such as the instructions for use must be observed. Furthermore:

Any person handling medical devices / IVDs is subject to a duty of care and must take all measures that are required, according to the state of the art, to ensure that health is not jeopardised (Art. 3 TPA).

Reporting incidents

Any professional who becomes aware of a serious incident when using medical devices and IVDs must report this to the supplier and the responsible authority. More information: Report Incidents & FSCA (Vigilance).

Devices for injection

Devices for injection intended to remain in the human body for longer than 30 days (long-term injectable devices) must only be used by a doctor or by a qualified healthcare professional with appropriate training in the injection of long-term implantable devices under the direct supervision and responsibility of a doctor (Art. 70 (2) and (3) and Annex 6 MedDo).