Relevant Swiss legal acts
Common specifications for product groups without an intended medical purpose dated 1 November 2023 (Federal Gazette)
Implementation guides
Relevant EU legal acts
Implementing Regulation (EU) 2022/2346 including Commission Implementing Regulation (EU) 2023/1194 of 20 June 2023 amending Commission Implementing Regulation (EU) 2022/2346 as regards the transitional provisions for certain products without an intended medical purpose listed in Annex XVI to the EU-MDR:
Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose
Additional relevant EU guidance
(The most recent version is available in DocsRoom.)
Publications on product groups without an intended medical purpose (swissmedic.ch)
Devices for modifying the anatomy or fixation of body parts
Breast enlargements
Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL)
updated information / 15.06.2021
PIP breast implants
Macrolane
Facial or other dermal or mucous membrane fillers
Injectable products for wrinkle treatment
Last modification 06.11.2023