Article 10(13) requires Manufacturers to have a system for recording and reporting of incidents and field safety corrective actions as described in Articles 87 and 88. The definitions of; "incident", "serious incident", "serious public health threat", "field safety corrective action" etc can be found in Article 2.
Article 87 requires Manufacturers of medical devices placed on the EU market (other than investigational devices) to report to the relevant competent authorities:
- Any serious incident involving devices on the EU market, except those expected side‑effects that are clearly documented in the product information and quantified in the technical documentation, which instead fall under trend reporting (Article 88).
- Any field safety corrective action (FSCA) relating to devices on the EU market, including FSCAs carried out in third countries if the underlying reason also applies to devices legally available in the EU.
Reports must be submitted in accordance with Articles 92(5) and 92(7) of the EU MDR 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 88 requires Manufacturers also to report any statistically significant rise in:
- incidents that are not serious, or
- expected undesirable side‑effects,
when that rise could meaningfully affect the device’s benefit–risk profile.
Article 89 additionally requires that, on reporting a serious incident under Article 87, 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.