Supervision of organ activity

Fimea is responsible for the supervision of the quality and safety related to donors and organs and for the traceability of information. The supervision covers regular inspections of organ donation hospitals and organ transplant center. In addition, Fimea monitors serious adverse events and serious adverse reactions observed in operation.

Fimea also maintains an up-to-date list of donation hospitals and the Transplant Centre and issues an annual report on transplantation operations on the basis of the information obtained from the Transplant Centre.

Read more:

Donation hospitals and Transplant Centre (pdf, in Finnish)

Statutes:

Fimea regulations 1/2016

Fimea regulations 2/2014

Act of the Medical Use of Human Organs, Tissues and Cells (101/2001) (Finlex, in Finnish, no english translation available) 

Decree of the Ministry of Social Affairs and Health on the Medical Use of Human Organs, Tissues and Cells (1302/2007) (Finlex, in Finnish, no english translation available) 

Decree of the Ministry of Social Affairs and Health amending the Decree of the Ministry of Social Affairs and Health on the Medical Use of Human Organs, Tissues and Cells (278/2014) (Finlex, in Finnish, no english translation available)

Government Decree on the Medical Use of Human Organs, Tissues and Cells (594/2001) (Finlex, in Finnish, no english translation available)

Directive of the European Parliament and of the the Council 2010/53/EU (pdf, in Finnish)