Medical devices

Only medical devices that conform with the 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 and performance. Except in exceptional circumstances, the device must bear the CE marking which proves conformity with the requirements.

Professional users have a duty to ensure the operations of the devices used by them, the availability of instructions, training for operating, and traceability of the products.

The provisions concerning medical devices contain the requirements for these products and the obligations of their manufacturers and professional users. The characteristics required of the devices include suitability for intended purpose, safety and reliability. Proper use of the device must not endanger the safety or health of the patient, user or other persons.

The function of the Valvira is to monitor the compliance of medical devices with the legislation and regulations and to promote their safe use.