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 requirements (Implementing Regulation 2023/1194), for product groups without an intended medical purpose.

The amendments on EU-MDR 2017/745, regarding changes to transitional periods for certificates, and on EU-MDR 2017/745 and EU-IVDR 2017/746, regarding the elimination of the sell-off period, were also transposed to the MedDO and IvDO. The approved amendments to the MedDO and IvDO will become effective on 1st November 2023.

More details can be found in the Swissmedic publication.