Registration and Marketing of Medical Devices in Denmark

1. General Requirements

Medical devices may only be placed on the market, made available, sold, distributed, or put into service in Denmark if they comply with EU Regulations 2017/745 (MDR) and 2017/746 (IVDR), along with Danish executive orders. No prior approval from authorities is needed before marketing. The manufacturer bears full responsibility for the device's safety and performance. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

2. CE Marking

Devices must bear CE marking to demonstrate compliance with EU regulations and Danish orders, following a conformity assessment procedure. For higher-risk classes (IIa, IIb, III for general devices; B, C, D for IVDs), the CE mark includes the notified body's identification number. The mark appears on the device, instructions for use, or sterile packaging, and sales packaging where possible. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

3. Classification

Classification follows Annex VIII of the respective EU regulations. European Commission guidance provides examples and further details. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

4. Risk Analysis

Manufacturers must perform and maintain risk analyses, identifying risks associated with intended use and ensuring they are acceptable relative to benefits. Analyses are updated for changes in production or market experience, with residual risks noted in labelling and instructions. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

5. Conformity Assessment and Documentation

Compliance with Annex I general safety and performance requirements is mandatory. Manufacturers prepare technical documentation, including risk analysis, surveillance systems, certificates, and clinical evaluations. Higher-risk devices require notified body review and certification. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

6. Market Surveillance and Vigilance

A post-market surveillance system is required to collect and process information on device performance and safety, enabling improvements and handling serious incidents or corrective actions. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

7. Declaration of Conformity

Manufacturers issue a declaration certifying legislative compliance, retained with technical documentation. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

8. Incident Reporting and Advertising

Serious incidents and field safety corrective actions are reported to the Danish Medicines Agency. Advertising must be factual, adequate, and consistent with intended use, regulated by Danish executive order no. 715 of 2022. Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/

9. Guidance Resources

Additional guidance includes documents for new manufacturers, labelling, parallel distribution, and a glossary (some in Danish only). Source: Danish Medicines Agency Registration and Marketing Page https://laegemiddelstyrelsen.dk/en/devices/registration-and-marketing/