Overview of the Finnish Medicines Agency (Fimea) and Medical Device Regulation

Finnish Medicines Agency (Fimea) - Medical Devices Overview

The Finnish Medicines Agency (Fimea) is the national competent authority responsible for the supervision of medical devices in Finland. Its primary goal is to ensure that medical devices placed on the market are safe, effective, and compliant with European and national regulations.

Key Roles and Responsibilities

Fimea performs several critical functions to protect public health:

• Supervision of Compliance: Monitoring the regulatory compliance of medical devices and the operators (manufacturers, importers, and distributors) in the sector.
• Market Surveillance: Overseeing devices already on the market, including their professional use and maintenance.
• Vigilance (Incident Reporting): Handling adverse incident reports from manufacturers and healthcare professionals to prevent future harm.
• Clinical Investigations: Evaluating and granting authorizations for clinical trials involving medical devices.
• Certificates and Derogations: Issuing Certificates of Free Sale (CFS) for export and granting exceptional derogations for medical devices when necessary.
• Marketing Oversight: Supervising the marketing and advertising of medical devices to ensure accuracy and compliance.

Regulatory Framework

Fimea operates within the framework of the European Union:

• EU Medical Device Regulation (MDR) 2017/745
• EU In Vitro Diagnostic Regulation (IVDR) 2017/746

Operator Registration

Fimea manages registrations for Finnish operators and devices, coordinating data with the European database EUDAMED. Ensuring up-to-date registration information is a legal responsibility of the operators.