The Swedish Medical Products Agency is stepping up its market surveillance of e-commerce in medical devices

On 13 April, the Swedish Medical Products Agency announced a new market surveillance project targeting importers of medical devices from countries outside the EU. The background to this is the rapid growth of e-commerce, and the surveillance aims to ensure that products reaching consumers via e-commerce comply with the requirements of the MDR and IVDR.

The Swedish Medical Products Agency states in its press release that the surveillance covers several types of medical devices. The inspections are partly risk-based, focusing on product groups with a higher risk class, but random inspections are also carried out. Importers have extensive responsibilities – these include ensuring correct CE marking, that the EU declaration of conformity with relevant legal requirements is in place, and compliance with applicable language requirements. It is important to note that importers must have registered in the EU’s EUDAMED database by 28 May 2026 at the latest.

In addition to registration, the targeted surveillance provides an opportunity for those importing medical devices from countries outside the EU to review their procedures regarding language requirements and compliance with the MDR and IVDR. If you require assistance with this or have any questions regarding the market surveillance project, please feel free to contact Setterwalls.