PROFESSIONAL USER:
Report the incident to Fimea and the manufacturer/authorised representative/importer/distributor.
See “Vaaratilanteista ilmoittaminen” (Reporting of incidents) for more information.
MANUFACTURER:
The procedure depends on the incident and the legislation applied to the device.
See “Manufacturer's incident reporting procedure” for more information.
IMPORTER:
Report the incident to the manufacturer and the manufacturer’s authorised representative.
DISTRIBUTOR:
Report the incident to the manufacturer and, where appropriate, to the manufacturer’s authorised representative and the importer.
AUTHORISED REPRESENTATIVE:
Report the incident to the manufacturer.