Medical devices

Medical devices range from simple wound dressings to implants, diagnostic equipment, and medical software. In Switzerland they are regulated separately from medicinal products, with requirements on conformity assessment, clinical evaluation, labeling, post-market surveillance, and reporting of serious incidents. Switzerland aligns many technical standards with European practice, but market access and mutual recognition issues can be sensitive in cross-border trade. Manufacturers, importers, distributors, healthcare institutions, and professionals each have compliance duties. The legal focus is whether the product performs as intended and whether risks remain acceptable for patients and users.