The Medical Devices Act (Official Gazette, no. 76/13) defines an adverse incident concerning a medical device as any malfunction of the medical device, performance failure, absence or impaired efficacy of the medical device, inadequacy of the effects of the medical device, including any deficiencies in labelling, instructions or packaging, where these adverse events lead or might have led to a death or a serious deterioration in health of the patient, user or third party.
An adverse incident that is required to be reported to the Agency for Medicinal Products and Medical Devices must meet the following criteria for reporting:
- fault, malfunction, deterioration of characteristics or performance of the medical device, general failure of a device to perform in accordance with its intended purpose when used in accordance with the manufacturer’s instructions,
- false positive or false negative test results that could result in life-threatening situations or that fall outside the declared performance of the test,
- unanticipated adverse reactions or unanticipated side effects,
- interactions with other substances or products,
- degradation/destruction of the device,
- inappropriate therapy,
- inaccuracy in labelling, instructions for use and/or promotional materials. Inaccuracies include omissions and deficiencies. Omissions do not include the absence of information that should generally be known by the intended users,
- h) other incidents and situations when testing a device, assessing information obtained by using a device, or any other scientific information that indicates a factor that could result or has resulted in an incident.
- Suspicion that a medical device is a contributory cause of an adverse incident, taking into account:
- the opinion, based on available evidence, of healthcare professionals,
- the results of the preliminary assessment of the adverse incident,
- evidence of previous, similar incidents,
- other evidence,
- complex situations when the manufacturer should assume that the medical device may have caused or contributed to an adverse incident and take precautionary measures.
- The outcome of the incident could be:
- death of the patient, user or other person,
- serious deterioration in state of health of a patient, user or other person.
A serious deterioration in state of health can include:
- life-threatening illness,
- permanent impairment of a body function or permanent damage to a body structure,
- a condition necessitating medical or surgical intervention to prevent a threat to life or permanent impairment of body functions or permanent physical damage,
- any indirect harm as a consequence of an incorrect diagnostic or in vitro diagnostic test result when used in accordance with the manufacturer’s instructions,
- foetal distress, foetal death or any other congenital abnormality or birth defect.
The manufacturer of a medical device must report adverse incidents to the Agency by the following deadlines:
- where there is a serious threat to public health: immediately, but not later than two days from the day the manufacturer became aware of the threat,
- where death or unanticipated serious deterioration in state of health occurred: immediately after the manufacturer establishes the link between the medical device and the incident, but not later than ten days following the date of awareness of the incident,
- others: immediately after the manufacturer establishes the link between the medical device and the incident, but not later than thirty days following the date of awareness of the incident.
The forms for reporting an adverse incident can be found here.