Incident reporting

Medical device adverse incidents must always be reported to the National Supervisory Authority of Welfare and Health as soon as possible.

Serious adverse incidents shall be reported within ten (10) days of the user or manufacturer first becoming aware of the incident. The cases of a near incident should be reported within thirty (30) days.

The duty to report applies to manufacturers and professional users of medical devices in Finland. Serious adverse incidents caused by a medical device made by a Finnish manufacturer occurring in another EEA State shall be reported to the authorities of the State where the incident occurred.

Failure to report is a punishable offence.

In urgent cases, reports may be made by telephone to +358 9 772 920. However, a written report shall also always be filed without delay.

National Supervisory Authority of Welfare and Health has issued regulations on reporting serious adverse incidents for users and manufacturers (in Finnish). The regulations are in force from 15 September 2010.

National Supervisory Authority of Welfare and Health notifies manufacturers, users and other relevant parties of steps to be taken in the event of a serious adverse incident.

Notifications are sent to the following address:

by email:
laitevaarat@valvira.fi

by mail:
Valvira
Medical Devices
Lintulahdenkuja 4
P.O.Box 210
FI-00531 Helsinki
FINLAND

Notifications can also be sent by fax (09)7729 2155