Danish Medicines Agency (Lægemiddelstyrelsen) Overview

The Danish Medicines Agency (DKMA) is an agency under the Danish Ministry of Interior and Health. It is the central authority responsible for the legislation and supervision of medical devices in Denmark, ensuring they are safe, effective, and of high quality.

Key Roles and Responsibilities:

• Regulatory Supervision: Administers Danish and EU legislation, specifically the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
• Clinical Investigations: Evaluates and authorizes applications for clinical trials of medical devices and performance studies for IVDs.
• Market Surveillance: Monitors devices already on the market through inspections of manufacturers and distributors.
• Vigilance (Materiovigilance): Receives and analyzes incident reports from companies, healthcare professionals, and citizens to prevent recurrences.
• Notified Bodies: Supervises the bodies responsible for certifying medical devices (CE marking).
• Registration: Manages the registration of Danish manufacturers, importers, and authorized representatives.
• Advice: Provides regulatory guidance to startups, SMEs, and researchers.

The Agency works closely with other EU member states to harmonize standards and improve health safety across Europe.