MDCG 2026-5 clarifies that only the manufacturer can assign UDIs to devices placed on the EU market, even where distributors market devices under their own brand.

The Swiss Federal Council recently approved a series of amendments to national legislation on medical devices, with a focus on strengthening patient safety, traceability through UDI and partial alignment with the European MDR Regulation. This legislative update aims to guarantee the continued safety and quality of medical devices marketed in Switzerland, even in the absence of an up-to-date Mutual Recognition Agreement with the European Union.