Any serious incident as well as any field safety corrective action (FSCA) in Austria are subject to mandatory reporting. 

European Regulation (EU) 2017/745 on medical devices as well as Regulation (EU) 2017/746 on in vitro diagnostic medical devices refers to an incident as a malfunction or deterioration in the properties or performance of a device already made available on the market, including application errors due to ergonomic features, as well as an inadequacy of the information provided by the manufacturer or an undesirable side effect. 

Serious incident means an incident that has had, could have had, or may have had, directly or indirectly, any of the following consequences: 

1. The death of a patient, user or other person, 
2. the temporary or permanent serious deterioration of the health of a patient, user or other person, 
3. A serious public health hazard. 

A corrective action is defined as an action to eliminate the cause of a potential or existing noncompliance or other adverse situation. A field safety corrective action means a corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident associated with a product made available on the market. 

Professionals who use or operate medical devices, as well as technical safety officers of hospitals, must immediately report to the Federal Office for Safety in Health Care (BASG) any serious incidents of which they become aware as a result of their professional activities. The manufacturer or, if applicable, the authorized representative of the product must also be informed. In the case of hospitals, this must be done uniformly by way of the medical director, except in the case of other imminent danger. 

A serious incident is defined as an incident that directly or indirectly led, might have led or might lead to any of the following: 

1. the death of a patient, user or other person 
2. the temporary or permanent serious deterioration of a patient's, user's or other person's state of health 
3. a serious public health threat 

If there is a suspicion of counterfeiting of a medical device, this must be reported immediately to the BASG. 

Products involved in incidents must not be destroyed but must be subjected to a root cause analysis. In this context, the healthcare institution 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. 

Online Reporting form for users and physicians

Further information:

• Requirements for healthcare facilities and healthcare professionals in regard to medical devices