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February 9, 2026
Approximately 5 minutes
Certificates of Free Sale for Medical Devices in Denmark
Certificates of Free Sale for Medical Devices in Denmark
1. Purpose and Eligibility
Certificates of free sale are issued for CE-marked medical devices under MDR and IVDs under IVDR, including those under transitional provisions. They are intended for export to countries outside the European Economic Area or without mutual recognition agreements with the EU. The certificate confirms free sale but is not an approval of the products. Source: Danish Medicines Agency Certificates of Free Sale Page https://laegemiddelstyrelsen.dk/en/devices/certificates-of-free-sale/
Non-CE marked devices are not eligible; contact the Danish Chamber of Commerce or Confederation of Danish Industry instead. Source: Danish Medicines Agency Certificates of Free Sale Page https://laegemiddelstyrelsen.dk/en/devices/certificates-of-free-sale/
2. Who Can Apply
Applications are accepted from manufacturers or authorised representatives based in Denmark and registered with the Danish Medicines Agency. Source: Danish Medicines Agency Certificates of Free Sale Page https://laegemiddelstyrelsen.dk/en/devices/certificates-of-free-sale/
3. Application Process
Submit via the online form, attaching the completed Excel template and supporting documents. Use specific templates for MDR or IVDR devices and desired languages. Fill company details on page 1 and product details (name, basic UDI, notified body certificate if applicable) on page 2. Ensure exact match with declarations of conformity. Attach up to 50 declarations of conformity (max 50 MB, fully digital PDFs). Separate applications are required for different regulations or languages. Source: Danish Medicines Agency Certificates of Free Sale Page https://laegemiddelstyrelsen.dk/en/devices/certificates-of-free-sale/
4. Required Documents
- Completed Excel template.
- Copies of declarations of conformity.
- For high-risk devices: Copies of EC certificates and design examination certificates.
- For transitional devices: Confirmation letter from notified body. Source: Danish Medicines Agency Certificates of Free Sale Page https://laegemiddelstyrelsen.dk/en/devices/certificates-of-free-sale/
5. Fees
The fee is DKK 1,362 per certificate (2026 rate). Separate fees apply for different languages or regulations. No additional fee for copies in the same language. Source: Danish Medicines Agency Certificates of Free Sale Page https://laegemiddelstyrelsen.dk/en/devices/certificates-of-free-sale/
6. Validity and Notes
Certificates are valid for 2 years, or shorter if specified in notified body certificates. Processing uses an automated system requiring precise template completion. Source: Danish Medicines Agency Certificates of Free Sale Page https://laegemiddelstyrelsen.dk/en/devices/certificates-of-free-sale/
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