Unlike medicinal products, medical devices do not undergo an official authorisation procedure. For these devices, Switzerland follows what is specified for the European Union (EU) system of compliance assessment and certification, based on bilateral agreements. Compliance with internationally valid norms is evaluated by private entities.
Medical devices are attributed to various risk categories that require varying assessment procedures. The visible result of a compliance assessment is the so-called CE label, which permits medical devices to be placed on the market within the EU and, based on unilateral recognition of the CE label, also in Switzerland.
Swissmedic's focus in the area of medical devices is thus on effective market surveillance. In addition, the designation and monitoring of the so-called conformity assessment bodies and the drafting of requirements in the form of technical standards also fall within Swissmedic's remit.
