Switzerland Medical Device Registration is the official procedure by which medical devices must be approved for sale and distribution within the Swiss market. Following Switzerland's updated alignment with the EU Medical Device Regulation (EU MDR 2017/745) via its own Swiss Medical Device Ordinance (MedDO), all devices must meet strict safety, efficacy, and quality standards.As Switzerland is considered a “third country” to the EU post-Brexit and post-MRA updates, additional requirements, such as appointing a Swiss Authorized Representative (CH-REP) for foreign manufacturers, have been introduced.
