Regulation of equipment that emits ionizing radiation in health care

The Ministry of Social Affairs and Health is the highest authority that guides the safety and regulation of radiation appliances and supplies in health care. Based on the Medical Devices Act (629/2010), Valvira supervises the compliance of the devices and supplies and promotes their safe use. In practice, the compliance of medical radiation appliances that enter the market is always assessed by a notified body with an appropriate qualification.

The Medical Devices Act also sets forth requirements on performing clinical examinations with regard to determining the performance or assessing side effects before devices or supplies can be placed on the market.

A safety licence issued by STUK is required for the clinical use of radiation appliances in health care in connection with product development. The licence application must include a statement by an ethics committee if the radiation use application has not been previously approved for clinical use.

STUK supervises the safe use of radiation appliances in health care under the Radiation Act. STUK must be notified of any abnormal incidents in the use of radiation.

Valvira must be notified of any emergencies concerning medical devices.
An emergency occurs if, during operation, the personnel identify a change or disturbance in the properties or performance of a device or insufficient markings or operating instructions that have led or might have led to severe health impairment or death of a patient, user or another person. Reports concerning patients’ protective devices are also submitted to Valvira.