Article 73 — Reporting of serious incidents

Providers must report serious incidents to the market surveillance authority of the country where they occurred, acting once a causal link with the system is established or reasonably likely. Deadlines vary with severity: generally fifteen days, but two for widespread infringements and ten where a death occurred; an incomplete initial report may precede a full one, then investigation and cooperation follow. Where equivalent reporting duties already apply, only limited incident types must be reported.