Additional regulatory information


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.)

Last modification 06.11.2023

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