The CH-REP's role in medical device registration and post-market surveillance is to monitor regulatory aspects that may affect its client. Following the abolition of the MRA, Switzerland introduced new obligations for the marketing of medical devices in the Swiss market. These obligations reflect the MDR/IvDR regulations.
Switzerland and Swissmedic (the competent authority) accept the EU declaration of conformity, which means that the issuance of a Swiss declaration of conformity is not necessary.
Switzerland also accepts the latest Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 with regard to transitional provisions for certain medical devices and in vitro diagnostic medical devices.