Medical Device Operators

Medical device operation

The Austrian Medical Devices Act 2021 and the Medical Devices Operator Ordinance (MPBV) regulate the operation of medical devices in healthcare facilities.

The focus here is on requirements for:

  • the operation in general
  • the incoming inspection, commissioning, maintenance and use
  • periodic safety inspections and metrological checks
  • the instruction of the personnel
  • the inventory and the device file
  • the implant register
  • the reprocessing of medical devices

Participation in vigilance

Members of a legally regulated health profession, persons authorized to operate or use a medical device on a professional basis, and technical safety officers of hospitals have the obligation to report incidents. In the case of hospitals, except in the case of other imminent danger, these must be made uniformly by way of the medical director.

Medical devices suspected of having caused harm to a patient must not be destroyed, but must be subjected to a cause analysis. It is the responsibility of the user or operator to take appropriate measures to identify and assess risks and, if necessary, to conduct or arrange for their own investigations. In this sense, it may well be appropriate to hand over a medical device to the manufacturer for a root cause analysis. Alternatively, in justified individual cases, own investigations can be carried out or commissioned. It should also be noted that the medical device alone is often not meaningful for a complete root cause analysis and can only lead to a conclusive root cause analysis together with, for example, the patient's medical history, X-ray images, OR reports, etc. The decision as to whether a medical device is to be assessed by the health care facility, the manufacturer or a third-party testing facility must be made on a case-by-case basis by the responsible physician or the operator. In this context, the healthcare facility is obliged to safeguard the legal position of the patient or any survivors with regard to the significance of the medical device for the enforcement of any liability claims.


Further inquiry note