The Danish Health and Medicines Authority issues Certificates of Free Sale to Danish manufacturers of medical devices with a registered place of business in Denmark. The manufacturer is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his own name.
A Certificate of Free Sale is issued for products which are to be exported to countries outside the European Economical Area (EEA) and countries without a mutual recognition agreement (MRA).
CE-marked devices
The Certificate of Free Sale verifies that the manufacturer has obtained the required certification from the notified body and issued a declaration of conformity in accordance with Council Directives:
- 93/42/EEC concerning medical devices
- 98/79/EC concerning in vitro medical devices
- 90/385/EEC concerning active implantable medical devices
Medical Devices which are CE-marked in conformity with the above directives meet the essential requirements for safety and performance. These devices may be manufactured and sold in Denmark without approval from the Danish Medicines Agency.
Non CE-marked devices
A Certificate of Free Sale can also be issued to Danish manufacturers of non CE-marked medical devices. The certificate states that the device(s) may be manufactured in Denmark and sold for export to countries outside the European Economical Area (EEA) and countries without a mutual recognition agreement (MRA) without approval from the Danish Medicines Agency.
Manufacturers must be aware that individual countries can have special rules in regards of importing medical devices. Please contact the local authorities for further information.
