Adverse Event Reporting and Labeling
Serious Adverse Event Reporting
Serious adverse events (SAE) in clinical investigations with medical devices are needed to report to the National Supervisory Authority of Welfare and Health immediately, but no later than two calendar days after awareness by sponsor of a new reportable event or new information in relation to already reported event (Regulation 3/2010 & MedDev 2.7/3). Abnormal incidents with radiant medical device should also be reported to Radiation and Nuclear Safety Authority (STUK) in Finland if the incident is related to the use of radiation (Radiation Act (592/1991). Any unusual events/adverse incidents relating to radiation must also be reported to STUK in addition to Valvira / Fimea.
Labeling and user instructions should be in Finnish and Swedish. If the device is intended only for professional use, English labeling is allowed. However, on the package it should be stated “ainoastaan kliiniseen tutkimukseen / endast för kliniska undersökningar” (only for clinical investigation). Patient information and the Informed Consent Form should always be both in Finnish and Swedish.