In medical device law, an incident refers to a problem with a product made available on the market or its information that must be evaluated for vigilance. A serious incident is a subset of these cases where the actual or potential outcome includes death, a serious deterioration in health, or a serious threat to public health. This classification determines whether the manufacturer must take action with the competent authority.
What is considered an incident
The MDR broadly defines the term. This includes malfunctions, a deterioration in characteristics or performance, inadequate information from the manufacturer, and undesirable side effects. A use error can also be included if it is due to ergonomic features. For diagnostic systems, it is also important whether a medical decision was based on information provided by the product and resulted in harm.
Initially, it is not crucial whether the product was actually the sole cause. The manufacturer evaluates the report, the device reference, the clinical course, and the available documentation. Serial number, software version, instructions for use, examination findings, and user feedback can answer different parts of the same question. A mere customer complaint only becomes a regulatory matter through this evaluation.
When an incident is serious
A serious incident may have directly or indirectly led to death, enabled it, or may lead to it in the future. The same applies to a temporary or permanent serious deterioration in the health of a patient, user, or third party. The third category concerns a serious threat to public health. Therefore, when assessing, it is not sufficient to look only at the actual consequence; the realistic potential for harm also counts.
The vigilance assessment links three questions: Has an incident occurred, has a serious outcome occurred or is it conceivable, and is there a causal link to the product? The link does not have to be conclusively proven. If it is established, reasonably possible, or merely suspected, the case requires careful regulatory handling. The technical root cause analysis must not unduly delay the decision on the initial report.
Distinction from adverse events and trend reports
An incident is a market term in medical device vigilance; in contrast, “serious adverse event” and “adverse event reporting” describe processes in the context of a study. While an adverse event focuses on the study participant, an incident relates to a product problem after it has been made available on the market. A clinical case can provide information for both systems, but the legal category remains different.
Only serious incidents are reported to the competent authority. Non-serious cases do not disappear from the quality system: the manufacturer documents them, looks for accumulations, and checks whether a trend report becomes necessary. A trend report therefore answers a different question than the individual report of a serious incident. It makes visible that the frequency or severity of non-serious events can yield a new risk signal statistically or clinically.
For market surveillance, this classification is also important because a single case can gain different weight through similar complaints from other countries. The case file should therefore record when the manufacturer became aware, what product identification was available, and what immediate protective measures were examined. This information makes the later decision between individual reporting, trend evaluation, and conclusion of the investigation verifiable.
Relevance for clinical trials
In a clinical investigation, study sites may report product problems, patient harm, and deviations from use in quick succession. The study protocol and safety processes must therefore define what information is passed on to the sponsor, to medical device vigilance, and, if applicable, to the ethics committee. Especially for investigational products with software components, the distinction between a clinical event, user action, and possible design flaw is essential for later risk assessment.
Full-service CROs like Mediconomics assist in establishing product-related reporting channels, coordinating SAE forms with vigilance data, requesting technical information from the study site, and performing traceable case triage. They can also check whether a documented malfunction impacts the risk analysis, clinical evaluation, or investigator information.
Frequently Asked Questions (FAQ)
Is every technical defect of a product a serious incident?
No. The defect must also have led, been able to lead, or be able to lead to one of the serious health or public health outcomes. Without this reference, it remains an incident to be evaluated or a quality information.
Can a use error be considered an incident?
Yes, if the error is due to ergonomic features of the product. Mere incorrect operation without such product reference does not automatically lead to medical device vigilance.
Why is a potential harm considered as much as an actual one?
The vigilance system aims to limit recurring or not yet re-occurred hazards. Therefore, a plausible serious outcome also requires an evaluation if the constellation could repeat itself with renewed use.
Regulatory References
- Regulation (EU) 2017/745, Article 2 and Article 87 – defines incidents and classifies the reporting of serious incidents.
- Regulation (EU) 2017/746, Article 2 and Article 82 – contains the corresponding terms and vigilance obligations for in vitro diagnostic medical devices.
- MDCG 2023-3 Rev.2, Questions and Answers on vigilance terms and concepts – explains the distinction and evaluation criteria.
- Regulation (EU) 2017/745, Annex III – establishes post-market surveillance as a data source for the manufacturer.
