Sale

Selling within Sweden or the EU/EEA

The regulations are the same for selling in Sweden and in other EU Member States. There is also no difference between selling devices in return for payment and giving them away for free. A medical device that complies with the requirements set out in the legislation can move freely within the whole Community market. All operators in a supply chain have some form of responsibility for ensuring the safety of the device.

Language requirements

The legislation gives EU Member States the opportunity to establish rules for the languages that must be used for the devices’ labelling, instructions for use, any screen text, displays and controls, for example. The vast majority of Member States require this information to be in the national language. Economic operators planning to import medical devices to Sweden from another Member State must therefore make sure that the labelling, instructions for use and other information is available in Swedish. Likewise, economic operators which sell to other markets must identify what language requirements are in place where the device will be sold.

Exporting to countries outside the EU/EEA

EU regulations and national regulations have no legal effect outside the EU/EEA. Therefore, as an exporter to other countries outside the EU/EEA, known as third countries, you must check which regulations apply for the country you are exporting to. Many countries outside the EU/EEA require a free sales certificate in order for the devices to be sold on the receiving market.

CE marking can sometimes be sufficient

In some cases, CE marking may either be mutually recognised as sufficient proof that the devices comply with the regulatory framework in the receiving country or be seen as a facilitating factor for this. If you intend to CE mark your device even if it will only be exported to countries outside the EU/EEA, it must of course meet the requirements for CE marking as defined in the law.