Notifications and applications

Fimea’s Medical Devices Unit is responsible for supervising the regulatory compliance of medical devices and for promoting their safe use. Central tools in the supervisory work are the statutory notifications or applications. Below is a list of notifications and applications filed in respect of devices.    

Reporting of adverse incidents

Manufacturer’s adverse incident report
Adverse incident report by a professional user

Clinical trial/performance evaluation

Application for the commencement of a clinical device trial
Notification of/application for an IVD device performance evaluation
Adverse event notification MD
Adverse event notification IVD

Notification of economic operator and medical device

Notification to Fimea’s CERE register
Operators’ liability to submit a notification to Eudamed

Other

Requesting a certificate of free sale
Applying for an exemption

The National Supervisory Authority for Welfare and Health (Valvira) oversees the implementation of the key requirements of the data systems intended for processing social welfare and healthcare customer and patient data. See the Valvira website for further information: Social welfare and healthcare data systems.