Medical devices

Medical devices

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.

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 Fimea as soon as possible.

Medical devices blue

Notifications and applications:

Manufacturer’s adverse incident report

Adverse incident report by a professional user

Application for the commencement of a clinical device trial

Notification of/application for an IVD device performance evaluation

Notification to Fimea’s CERE register

Operators’ liability to submit a notification to Eudamed

Contact information:

Adverse incident reports: meddev.vigilance@fimea.fi

Inquiries by the authorities and general inquiries: medicaldevice@fimea.fi

Clinical trials on medical devices and performance evaluations: cie@fimea.fi

Registration matters, export certificate requests: laiterekisteri@fimea.fi