Need Regulatory Help? Try Our Platform
Post your regulatory questions or request quotations from verified pharmaceutical consultants worldwide. Get matched with experts who specialize in your market.
February 2, 2026
Approximately 5 minutes
Incident Reporting for Medical Devices in Denmark
Incident Reporting for Medical Devices in Denmark
1. Overview and Purpose
Incident reporting helps monitor medical device safety post-market. Reports allow the Danish Medicines Agency to identify risks, investigate causes, and implement measures like recalls or updates to instructions. Source: Danish Medicines Agency Incident Reporting Page https://laegemiddelstyrelsen.dk/en/devices/incident-reporting/
2. Who Must Report
- Manufacturers: Required to report serious incidents within specified deadlines.
- Healthcare professionals and hospital entities: Obliged to immediately report serious or suspected serious incidents.
- Self-employed healthcare professionals outside public services: Also obliged.
- Citizens (patients, relatives, users): Can voluntarily report suspected serious incidents.
- Authorised representatives, importers, distributors: Must immediately inform the manufacturer and may report directly to the Agency. Source: Danish Medicines Agency Incident Reporting Page https://laegemiddelstyrelsen.dk/en/devices/incident-reporting/
3. What to Report
Report serious incidents or suspected serious incidents, including malfunctions, failures, or deficiencies that have caused or could cause death or serious deterioration of health. This applies even if the device was not directly at fault. Medical devices include items like crutches, pacemakers, diagnostic tests, and mobile apps. If the incident is also an adverse event under the Danish Health Act, report it separately to the Danish Patient Safety Authority. Source: Danish Medicines Agency Incident Reporting Page https://laegemiddelstyrelsen.dk/en/devices/incident-reporting/
4. Reporting Deadlines and Process
- Manufacturers follow specific deadlines per legislation.
- Healthcare entities and professionals report immediately for serious/suspected incidents.
- Other economic operators report immediately to the manufacturer. The Agency forwards reports from users/professionals to the manufacturer for investigation. The Agency reviews all reports and may require corrective actions. Source: Danish Medicines Agency Incident Reporting Page https://laegemiddelstyrelsen.dk/en/devices/incident-reporting/
5. How to Report
Submit reports to the Danish Medicines Agency:
- Address: Axel Heides Gade 1, 2300 Copenhagen S
- Telephone: +45 44 88 95 95
- Email: Via contact form on the website Specific guidance for manufacturers available separately. Source: Danish Medicines Agency Incident Reporting Page https://laegemiddelstyrelsen.dk/en/devices/incident-reporting/
6. Data Protection and Rights
The Agency processes personal data under the Danish Act on Medical Devices and EU regulations. Data is retained for safety monitoring purposes. Individuals have rights to access, rectification, and complaint to the Data Protection Agency. Source: Danish Medicines Agency Incident Reporting Page https://laegemiddelstyrelsen.dk/en/devices/incident-reporting/
Ask Anything
We'll follow up with you personally.
Related Articles
Approximately 5 minutes
Danish Medicines Agency Regulation of Medical Devices
The Danish Medicines Agency oversees medical devices in Denmark, ensuring EU compliance through CE marking, handling vigilance reports, clinical investigations, supply interruptions, and providing guidance to manufacturers, professionals, and citizens.
Approximately 5 minutes
Key Changes to IVD Regulation in Denmark under EU IVDR
The EU In Vitro Diagnostic Medical Devices Regulation (IVDR) applied from May 2022 introduces risk-based classification, increased notified body involvement, stricter performance evaluation requirements, and transitional provisions to ensure continued access to safe IVDs in Denmark.
Approximately 5 minutes
Extension of EU IVDR Transitional Provisions for In Vitro Diagnostic Medical Devices
The EU extended IVDR transitional provisions to address implementation challenges, allowing legacy IVDs to remain on the market until 2025-2027 depending on risk class, while in-house devices gain phased compliance extensions to ensure continued availability and patient safety.
Approximately 5 minutes
Danish Medicines Agency FAQ on Artificial Intelligence in Medical Devices
The Danish Medicines Agency provides guidance on AI in medical devices, covering qualification, classification, conformity assessment, clinical evaluation, and challenges with continuous learning systems under EU MDR.