A serious incident under Article 73 must be reported to the market surveillance authority of the member state where the incident occurred. For systems deployed across multiple member states, the incident response plan must include pre-identified reporting channels for every deployment jurisdiction, pre-translated incident report templates where the authority requires the national language, and a coordination procedure ensuring the same incident is reported consistently to all relevant authorities.
Where an incident occurs in one jurisdiction but affects persons in another, the coordination procedure addresses which authorities receive which reports and in what sequence. The parallel reporting framework described in provides the operational basis, extended to cover all deployment jurisdictions.
The incident response plan identifies the authority contact, reporting format, language requirement, and deadline for each deployment jurisdiction. This information is pre-populated in the regulator contact register and tested annually during tabletop exercises.
Key outputs
- Pre-identified reporting channels per deployment jurisdiction
- Pre-translated incident report templates
- Cross-border coordination procedure
- Module 10 AISDP documentation