Article 10(12) requires Manufacturers to have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 82 and 83. The definitions of; “incident”, “serious incident”, “serious public health threat”, “field safety corrective action” etc can be found in Article 2.
Article 82 requires Manufacturers of IVDs placed on the EU market (other than devices for performance studies) to report to the relevant competent authorities:
- Any serious incident involving IVDs on the EU market, except expected erroneous results that are clearly documented and quantified in the product information and technical documentation, which instead fall under trend reporting (Article 83).
- Any field safety corrective action (FSCA) relating to IVDs on the EU market, including FSCAs undertaken in third countries if the reason for the action is not limited to devices outside the EU.
Reports must be submitted in accordance with Articles 87(5) and 87(7) of the EU IVDR and the following timelines;
- Immediately, and no later than 2 days - if the serious incident represents a serious public health threat.
- Immediately, and no later than 10 days - if the serious incident led to the death of a patient or user, or to an unanticipated serious deterioration in health.
- Immediately, and no later than 15 days - for all other serious incidents that do not fall into the above categories.
- Immediately upon becoming aware of the need for a Field Safety Corrective Action (FSCA) - for any FSCA relating to devices on the EU market (including FSCAs initiated in third countries if the underlying reason also applies to devices legally available in the EU).
Article 83 requires Manufacturers to also report any statistically significant rise in:
- incidents that are not serious, or
- expected erroneous results,
when that rise could affect the device’s benefit–risk profile or performance.
Article 84 additionally requires that, on reporting a serious incident under Article 82, the Manufacturer must;
- Investigate the serious incident without delay.
- Perform a risk assessment and evaluate whether an FSCA is needed.
- Cooperate fully with competent authorities (and notified bodies where relevant).
- Not alter the device before informing authorities.
- Provide investigation results and follow‑up information.
- Implement any necessary field safety corrective actions.