Economic operators for medical devices are those involved in the design, manufacture, import, distribution and placing on the market of medical devices. They are defined as manufacturers, authorised representatives, importers and distributors.

The following parties play a key role in ensuring that medical devices meet the requirements and are available in a safe and reliable manner within the EEA. The Icelandic Medicines Agency (IMA) does not keep a register of individual medical devices.

• Manufacturer. A natural or legal person who manufactures or fully refurbishes a medical device, or has one designed, and markets it under their own name or trademark.

• Authorised. representative. A natural or legal person established within the EEA who holds a written mandate from a manufacturer located outside the EEA to carry out specified tasks on the manufacturer's behalf in relation to its legal obligations.

• Importer. A natural or legal person established within the EEA who imports medical devices from countries outside the EEA and places them on the market within the EEA.

• Distributor. A natural or legal person in the supply chain, other than the manufacturer or the importer, who makes medical devices available on the market, e.g. a pharmacy selling devices to the general public. A person is only considered a distributor if they make available on the market a medical device manufactured within the EEA, or purchase a device manufactured outside the EEA from an importer who has already placed the device on the market within the EEA. If the device is manufactured outside the EEA and the person places it on the market within the EEA themselves, they are considered an importer.