New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices. The Federal Council of Switzerland has decided to amend the Medical Devices Ordinance (MedDO) in alignment with EU requireme...

Swissmedic evaluated compliance declarations from a random sample of 27 Swiss manufacturers of Class I medical devices between August and December 2022. The results revealed poor performance among manufacturers, with 70% of post-market surveillance (PMS) documentation failing to meet legal standards...