Overview of the Norwegian Medical Products Agency (DMP) and Medical Device Regulation

Overview of the Norwegian Medical Products Agency (DMP)

The Norwegian Medical Products Agency (DMP), formerly known as NoMA (Statens legemiddelverk), is the national regulatory body for pharmaceuticals and medical devices in Norway. Subordinate to the Ministry of Health and Care Services, its mission is to ensure access to safe and effective health products while fostering innovation.

Role in Medical Devices

As Norway is part of the European Economic Area (EEA), the DMP acts as the competent authority harmonizing Norway's regulations with the European Union. It oversees the entire lifecycle of medical devices available on the Norwegian market.

Key Responsibilities

• Regulatory Oversight: Implements and enforces the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) through national law.
• Market Surveillance: Conducts risk-based inspections of manufacturers, importers, and distributors to ensure compliance with safety and performance standards.
• Clinical Investigations: Evaluates and authorizes applications for clinical trials of medical devices to ensure participant protection and data validity.
• Vigilance (Materiovigilance): Coordinates the reporting and analysis of serious incidents and field safety corrective actions (FSCAs) to prevent recurrence.
• Notified Body Supervision: Oversees the organizations in Norway designated to assess device conformity before they are CE marked.
• Registration: Manages registration requirements for economic operators in the EUDAMED database and the Norwegian national register.