Europe: Medical Device Incident Reporting

Regulatory authorities across Europe receive hundreds of thousands of medical device incident reports each year, including suspected device‑related deaths, serious injuries, and malfunctions. The medical device incident reporting system plays a vital role in monitoring device performance, identifying potential safety concerns, and supporting benefit–risk assessments throughout a device’s lifecycle.

Under the Medical Device Regulation (MDR 2017/745), manufacturers of devices placed on the EU market (other than investigational devices) must report the following to the relevant national competent authorities, as outlined in Articles 92(5) and 92(7):

1. Any serious incident involving devices made available on the EU market, except for expected side‑effects that are clearly documented in product information, quantified in technical documentation, and subject to trend reporting under Article 88.
2. All reports must be submitted through the electronic system described in Article 92. Reporting timelines must reflect the seriousness of the incident.
3. Manufacturers must report any serious incident as soon as they establish, or believe it is reasonably possible, that a causal relationship exists between the incident and their device. Reports must be submitted no later than 15 days from the moment the manufacturer becomes aware of the incident.
4. In cases involving a serious public health threat, manufacturers must report the incident immediately and no later than within 2 days of awareness.
5. For incidents involving death or unexpected serious deterioration in a person’s health, reporting must occur immediately upon suspecting or confirming a causal link, and no later than 10 days from awareness.
6. Where necessary, an initial incomplete report may be submitted to ensure timely notification, followed by a complete report when available.
7. Manufacturers must report any field safety corrective action (FSCA) affecting devices made available on the EU market, including FSCAs initiated in third countries if they relate to devices also marketed in the EU. In urgent cases, the manufacturer may proceed immediately but must notify authorities without undue delay.
8. For similar serious incidents involving the same device or device type—when the root cause is known, an FSCA is implemented, or incidents are well documented—the manufacturer may submit periodic summary reports instead of individual reports. This is allowed only if agreed upon with the coordinating competent authority and other applicable authorities as referenced in Article 92.
9. If a manufacturer is unsure whether an incident is reportable, it must submit a report within the required timeframe regardless.
10. If the manufacturer concludes that an incident is a serious incident, it must report this to the competent authority of the Member State where the incident occurred and take appropriate follow‑up actions in line with Article 89.
11. If the manufacturer believes the incident is not serious or is an expected undesirable side effect to be covered under trend reporting, it must provide a justification. If the competent authority disagrees, it may request a full report and require necessary follow‑up actions in accordance with Article 89.

Member States must take measures—such as targeted information campaigns—to enable and encourage healthcare professionals, users, and patients to report suspected serious incidents. These user‑initiated reports, combined with additional data sources, contribute significantly to strengthening patient safety.

When a competent authority receives suspected serious incident reports from healthcare professionals, users, or patients, it must promptly inform the device manufacturer. All such reports must be recorded centrally at the national level to ensure coordinated oversight and monitoring.