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Devices which produce ionising radiation and accessories in public health

The safety and regulation of radiation devices and accessories used in the public health care sector is primarily regulated by the Ministry of Social Affairs and Health. On the basis of the Medical Devices Act, the task of the Finnish National Agency for Medicines (NAM) is to ensure that devices and accessories are compliant and to promote safe usage. In practice, the compliance of medical radiation devices coming on to the market is always evaluated by a notified body shown to be suitable for the task.

The Medical Devices Act also contains regulations concerning clinical research about defining performance or evaluations of side-effects before the device or accessory is brought on to the market. A safety licence, granted by STUK, is required for clinical use in order to develop medical radiation devices. A statement by an ethics committee must be attached to the application if the type of radiation application has not previously been approved for clinical use.

STUK regulates the safe usage of medical radiation devices, based on the Radiation Act. Any unusual events while using radiation must be reported to STUK.

Any hazardous situations related to these devices must be reported to the Finnish National Agency for Medicines (NAM). A hazardous situation has taken place when a change or disturbance in the characteristics or performance of a device or accessory is observed. Also, any inadequate markings or user instructions which could lead to a patient, operator, or other person’s seriously diminished health or death is classed as a hazardous situation. Incidents involving the protection of patients must be reported to the Finnish NAM.

Page updated 25/10/2005
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