Medical devices vigilance

Reporting forms

General information

In the case of medical devices, including in vitro diagnostic medical devices (IVDs), device-related serious or near serious incidents must be reported to the competent authority. Even the possibility of causal involvement of a medical device in a serious incident is already reportable. According to § 70 of the Austrian Medical Devices Act, the notification must be made immediately to the Federal Office for Safety in Health Care (BASG).

In addition, manufacturers, distributors and importers must immediately report any field safety corrective actions to the BASG

Incidents

In order to ensure patient safety and to minimise the recurrence of health hazards, Austria has established an obligation to report incidents to the Federal Office for Safety in Health Care.

The obligation to notify exists both for professional users and for distributors and manufacturers of medical devices. Furthermore, heads of relevant testing, inspection and certification bodies as well as technical safety officers of hospitals are explicitly included in this reporting obligation. (cf. § 70 para. 1 Medical Devices Act)

The following are deemed to be notifiable

  • all serious incidents (including "near incidents")
  • unknown serious side effects or accumulations of side effects
  • Unknown mutual influences and
  • serious quality defects

Severe means

  1. Death of a patient or user
  2. Life-threatening disease
  3. Permanent impairment of body function or permanent damage
  4. Medical or surgical intervention to avert 1-3 (e.g. significant prolongation of surgery time, inpatient treatment or prolongation of inpatient stay, etc.)
  5. Risk or damage to a fetus, its death or congenital malformation
  6. Occurrence of a malignant tumor
  7. Indirect damage caused by the malfunction of an in vitro diagnostic device (misdiagnosis, delayed diagnosis or treatment, unsuitable treatment, transfusion/transplantation of unsuitable materials, etc.)

Timescale for the initial reporting of an incident

The notification shall be made "immediately" as soon as a connection can be established between the malfunction of the medical device and the event.

"Immediate" means "without unjustifiable delay". Taking into account MedDev 2.12/1, the following deadlines are defined in more detail:

  • Serious risk to public health: Immediately (without any delay that could not be justified) but not later than 2 calendar days after awareness by the manuacturer of this threat.
  • Death or unanticipated serious deteriorationin state of health: Immediately (without any delay that could not be justified) after the manuacturer established a link between the device and the event but not later than 10 elapsed calendar days following the date of awareness of the event.
  • Others: Immediately (without any delay that could not be justified) after the manuacturer established a link between the device and the event but not later than 30 elapsed calendar days following the date of awareness of the event.
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