Medical Device Regulation in Denmark
Denmark regulates medical devices under the EU Medical Device Regulation (EU MDR 2017/745). The Danish Medicines Agency (Lægemiddelstyrelsen) is the national competent authority. Denmark has a strong medtech innovation ecosystem and is recognized for its high standards in healthcare regulation and digital health.
Recent Regulatory Updates
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Pharmaceutical reimbursement process in Denmark.
Danish reimbursement application procedures.
New Danish medicine reimbursement thresholds for 2026.
Sources Tracked by Qalico
Qalico continuously monitors 4 references across guidelines, regulations, and standards for Denmark.
Regulations
Guidelines
Device Classification
Denmark follows the EU MDR classification system. Class I devices are low risk (e.g., manual hospital beds, cold packs). Class IIa devices are low-moderate risk (e.g., dental materials, electrocardiographs). Class IIb devices are moderate-high risk (e.g., lung ventilators, blood bags). Class III devices are high risk (e.g., hip joint prostheses, implantable cardiac devices). Classification follows EU MDR Annex VIII.
Official classification guidance →Official Guidance Documents
Official guidance from the Danish Medicines Agency on medical device regulation, registration, and compliance in Denmark.
Guidance on applying for clinical investigation authorization for medical devices in Denmark.
The European database for medical device registration and UDI management.
Standards & Key Principles
Applicable Standards
Key Principles
- Medical devices must bear the CE mark under EU MDR 2017/745 to be sold in Denmark.
- Manufacturers must register in EUDAMED and comply with UDI requirements.
- Notified body involvement is required for Class IIa and above.
- Non-EU manufacturers must appoint an authorized representative within the EU.
- Denmark maintains a national device registration system in addition to EUDAMED.
- Post-market surveillance and vigilance reporting to DKMA are mandatory.
Pre-Market Requirements
Devices must comply with EU MDR 2017/745 and carry CE marking. Notified body assessment is required for Class IIa, IIb, and III devices.
Complete technical files per EU MDR Annexes II and III must be prepared, including risk management, design verification, and clinical data.
A clinical evaluation is mandatory for all device classes under EU MDR Article 61. Clinical investigations in Denmark require DKMA authorization and ethics committee approval.
Manufacturers must register in EUDAMED and may also need to register with the DKMA's national database.
Post-Market Requirements
A PMS system must be maintained per EU MDR. PSURs are required for higher-risk device classes.
Serious incidents and field safety corrective actions must be reported to the DKMA per EU MDR requirements.
PMCF activities must be conducted to continuously confirm the clinical safety and performance of devices.
International Recognition & Reliance
CE-marked devices under EU MDR are freely circulated across all EU/EEA member states.
CE-marked devices from EU member states are recognized in Switzerland under the MRA framework.