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Upcoming Legislative Changes

Overview​

Swiss medical device legislation — primarily MedDO (SR 812.213) and IVDO (SR 812.219) — can be amended by the Federal Council via ordinance amendment. Major structural changes require parliamentary amendment of the TPA. This page tracks announced and proposed legislative changes.

Always verify with official sources

Legislative processes move at their own pace. Always verify the current status of proposed changes directly with Fedlex, Swissmedic, and SECO.

How to Track Upcoming Legislative Changes​

Federal Council consultation procedures (Vernehmlassung) Major ordinance amendments are subject to formal consultation before enactment. Open consultations are published at: fedlex.admin.ch — consultation procedures

Federal Gazette (Bundesblatt/Feuille fédérale) Enacted changes are published in the Federal Gazette before they take effect in the consolidated SR text on Fedlex. The Gazette is published every Tuesday and Friday at: fedlex.admin.ch — Bundesblatt

EU MDR/IVDR amendments Because MedDO mirrors EU MDR and IVDO mirrors IVDR, significant EU MDR/IVDR amendments (via EU Delegated or Implementing Regulations) are likely to trigger corresponding Swiss amendments. Monitor: eur-lex.europa.eu — MDR amendments

Changes to the CH–EU bilateral agreement framework can have indirect legislative implications for MedDO/IVDO registration requirements. See MRA Status Updates.

Common Triggers for MedDO/IVDO Amendment​

  • EU MDR/IVDR implementing or delegated regulation updates (transitional dates, UDI timelines, eIFU conditions)
  • New EU Annex XVI devices (non-medical purpose devices added to MDR scope)
  • Updated harmonised standards lists
  • Technical corrections and clarifications

Official Sources​

Disclaimer

AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.