Only medical devices that conform with existing regulations can be placed on the market or put into service in Finland.
Before placing a new product on the market the manufacturer must be able to establish its safety, suitability for intended use, performance and reliability. As a rule, the device must bear the CE marking that indicates conformity with the requirements.
The National Supervisory Authority for Welfare and Health Valvira monitors the compliance of medical devices with the legislation and regulations, monitors the marketing of medical devices and promotes their safe use. Till the end of October 2009 these tasks were carried out by the National Agency for Medicines.
Proper use of the device must not endanger the safety or health of the patient, of the user or of other persons. Professional users have a duty to ensure the operability of the devices used by them, the availability of instructions, training for operators, and traceability of the products. Adverse incidents relating to medical devices must always be reported to Valvira as soon as possible.
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Consumer Agency, KUV European Commission, Medical Devices European Medicines Agency, EMEA Finnish Funding Agency for Technology and Innovation, TEKES Ministry of Social Affairs and Health, STM National Institute for Health and Welfare, THL