Certificates of Free Sale to Danish manufacturers of medical devices
Free Sale Certificates for Danish manufacturers of medical devices
The Danish Medicines Agency issues Free Sales Certificates (FSC) to manufacturers and authorized representatives of medical devices, who are headquartered in Denmark and registered with the Danish Medicines Agency. Free Sale Certificates are issued for products which are exported outside of the European Economic Cooperation and to countries without a mutual recognition agreement with the EU.
Free Sale Certificates are issued for equipment which is CE-marked according to the Medical Device Regulation (MDR), equipment that follow transitional provisions laid out in the Directives and In Vitro-diagnostic medical devices (IVD) CE-marked according to the Directive for IVD.
The Danish Medicines Agency does not issue Free Sales Certificates for non-CE marked medical devices. Instead, the Confederation of Danish Industry (DI) Chamber of Industry and Commerce Section can be contacted through their website for their issuance.
The Danish Medicines Agency issuance of Free Sale Certificates is not a validation of the products presented in the certificate. Issued Free Sale Certificates are valid for 2 years, unless Notified Body certificates are valid for a shorter period. The period of validity will be adjusted to match the expiration date of the Notified Body certificate.
Fees and Free Sale Certificates
Free Sale Certificates are subject to a fee of 1,200 DKK per request, please see Executive Order no. 1100 of 01/06/2021 (only available in Danish). Requests for certificates in different languages are viewed as separate requests and are charged with individual fees. Additional fees are not charged for multiple copies of the same Free Sale Certificate. The fee of 1,200 DKK is imposed regardless of the number of medical devices provided in the Free Sale Certificate.
IVD medical devices are currently not subject to imposed fees until the implementation of In Vitro-Diagnostics Regulation (IVDR) on the 26th of May 2022.
How do I apply for Free Sale Certificates?
Find the template you need to use in the table below. Right-click on “Download” and choose “Save as” and save the template on your computer.
|Medical devices (MDR)||Download||Download|
|Medical devices (MDD), transitional provisions||Download||Download|
|EC Representative (MDR)||Download||Download|
|EC Representative (MDD), transitional provisions||Download||Download
Fill in company address on page 1 of the template and products on page 2 in the font “Arial”. When the template is complete with information, send an e-mail to our certification inbox with your application where you inform of the number of requested Free Sales Certificates and the address and name of the person who will be receiving the certificates.
Attached the completed template and necessary documentation: Declaration(s) of Conformity and certificate(s) from the Notified Body.
We aim to issue the Free Sales Certificates within 10 working days, assuming the application is sufficient. If the application is missing information, we will contact you.
There must be unambiguous correlation between the product names listed in the Free Sale Certificate(s), Declaration of Conformity and certificates from the Notified Body. As such, please precisely list the product name in the Free Sale Certificate as it is listed in the remaining documentation.
For CE-marked class I medical devices, you need to only supply the Declaration(s) of Conformity for the products listed in the Free Sale Certificate(s).
For system- and procedure packs, we need to see a copy of the declaration that pertain to interoperability and compatibility as described in the Regulation of Medical Devices (EU) 2017/745.
For equipment with a certificate from a Notified Body, you are kindly asked to attach copies of relevant valid certificates.
Always attach the completed Free Sale Certificate template
You must always attach a completed Free Sale Certificate template when you apply for said certificate. If you have previously received Free Sale Certificates on the same products, you may reuse the same template, potentially with an updated list of products.
If you need Free Sale Certificates on multiple products which are regulated under different executive orders, you are asked to send a completed template for each relevant executive order. The same applies for different languages of the certificates.
If you are going to export medical devices, you can find advice and guidance on the Ministry of Foreign Affairs website and with your branch organization.
Remember to be vigilant that different countries you wish to export to may have special rules on the subject.