Certificates of Free Sale to Danish manufacturers of medical devices
Issuance of certificate of free sale to Danish medical device manufacturers
The Danish Medicines Agency issues certificates of free sale to manufacturers and authorised representatives that are based in Denmark and registered with the Danish Medicines Agency. Certificates of free sale are issued for products to be exported to countries outside the European Economic Area and to countries that have not concluded a mutual recognition agreement with the EU.
Certificates of free sale are issued for medical devices that are CE marked according to the EU regulation on medical devices (the MDR) and in vitro diagnostic medical devices (IVD devices) that are CE marked according to the EU regulation on in vitro diagnostic medical devices (the IVDR). (This includes devices that follow the transitional provisions of article 120 of the MDR and article 110 of the IVDR.)
The Danish Medicines Agency does not issue certificates of free sale for non-CE marked medical devices. If you need a certificate for such devices, contact the Danish Chamber of Commerce or the Confederation of Danish Industry.
A certificate of free sale issued by the Danish Medicines Agency is not to be taken as an approval of the products included on it. Certificates of free sale are valid for 2 years, unless EC-certificates issued by the notified body state a shorter period.
How much does a certificate of free sale cost?
Certificates of free sale are subject to a statutory fee as regulated by the Danish Executive Order no 839 of 20 June 2023. In 2025, a certificate costs DKK 1,341 per certificate requested. Orders for certificates in multiple languages are considered separate requests, and a fee will be charged for each request. There is no extra fee for copies of the same certificate in the same language. Also, separate orders are needed for certificates for devices that are CE marked under different directives/regulations. The fee of DKK 1,341 is charged irrespective of the number of devices appearing on the certificate of free sale.
How to apply for a certificate of free sale
The Medical Devices department is pleased to present MUCERT, a new robot that will automate parts of the certificate ordering process. We are implementing MUCERT to make the issuance of certificates faster and more streamlined. For MUCERT to work efficiently, we need you to complete the template exactly as instructed below. Also, the PDF file you attach must be fully digital as MUCERT cannot process scanned documents.
Find the relevant template below. Click on "Download” to save the template on your computer.
| English | Spanish | ||
|---|---|---|---|
| Medical device (MDR) | Download | Download | |
| Medical device (MDD), transitional provisions | Download | Download | |
| In vitro diagnostic medical device (IVDR) | Download | Download | |
| In vitro diagnostic medical device (IVDD), transitional provisions | Download | Download |
|
| Authorised representative (MDR) | Download | Download | |
| Authorised representative (MDD), transitional provisions | Download | Download | |
| Authorised representative (IVDR) | Download | Download | |
| Authorised representative (IVDD), transitional provisions | Download | Download | |
How to fill in the Excel template
- Fill in the name and address of the company on page 1 of the template.
- Fill in the product details on page 2 of the template. Use the font Arial.
- Make sure to fill in the following columns correctly:
- Column A: Product name
- Column B: Basic UDI number
- Column C: Notified body certificate number (relevant only for high-risk devices).
Please note that these columns must maintain their original position in the template.
- The product names and basic UDI numbers you enter in the template must match exactly and be unambiguously linked to those of the associated declarations of conformity. In other words, you must provide the product names/product designations exactly as they appear on the declaration(s) of conformity.
If you want further device details to appear on the certificate of free sale, then switch the page layout of the Excel template to landscape by clicking “Layout → Orientation → Landscape”; you can then add any further device details to the product list.
Note: Please delete all the “red” text in the template before submission.
You apply for a certificate of free sale by attaching the Excel template, and any other relevant documentation, to the form.
If you have any questions, please contact us by e-mail or call +45 44 88 95 95.
Documentation requirements
For CE marked devices, you must always attach a copy of the applicable declarations of conformity for the products listed on the export certificate.
For devices covered by a certificate from a notified body, please attach copies of the relevant certificates in force: EC certificates and any design examination certificates.
For devices subject to the transitional provisions, please attach a ’confirmation letter’ from a notified body.
Always attach the template
Remember always to attach a duly completed template when you apply for a certificate of free sale. If you are requesting certificates for several products that fall under different directives/regulations, you must complete a template and request form per directive/regulation. The same applies if you need different language versions.
For advice and guidance on exporting medical devices, please also visit the website of the Ministry of Foreign Affairs of Denmark and ask your industry organisation.
Please be aware that separate rules may apply in the importing country or countries.