What are CE marked Medical Devices?
A CE mark is a symbol used for medical devices to show they comply with the requirements outlined in the EU’s directives. It proves that the device is fit for its intended purpose and meets the EU legislation relating to safety. It also shows that the product can be freely marketed anywhere in the European Union (27 member states of the EU and EFTA countries, Iceland, Norway and Liechtenstein).
CE marking does not indicate the origin of the product. You are not required to comply with any national schemes when exporting these devices to countries outside the European Union. CE marked medical devices are subject to inspection by the market surveillance authorities of the relevant member states.