Medical devices vigilance
- Formular: Vorkommnis melden| 180 KBMeldeformular für Hersteller und Bevollmächtigte Medizinprodukte-Beobachtungs- und Meldesystem18/12/2019
- Ausfüllhilfe: Vorkommnis melden| 259 KBUnterstützung für das Ausfüllen und Übermitteln der Meldung durch Inverkehrbringer von Medizinprodukten18/12/2019
- Formular: FSCA melden| 1 MBMeldeformular Field Safety Corrective Action (FSCA) Medizinprodukte-Beobachtungs- und Meldesystem28/07/2021
Obligation to report
Any serious incident as well as any safety corrective action in the field 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:
- The death of a patient, user or other person,
- the temporary or permanent serious deterioration of the health of a patient, user or other person,
- 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.