Medical devices
Activities implied by the legislation governing the safety of medical devices marketed in the Czech Republic. Pursuant to Act No 123/2000 Coll., on Medical Devices, as amended, SÚKL investigates and evaluates adverse incidents of medical devices, inspects the conduct of clinical evaluations or clinical trials on medical devices. It inspects medical devices at the workplaces of healthcare providers, in which it focuses primarily upon the record-keeping and documentation of medical devices, e.g. on records about the conduct of maintenance and repairs, records about trainings, periodic controls and adverse incidents.
