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.