Recent Regulatory Changes
Overview
This page tracks recent regulatory changes to Swiss medical device regulation. For the definitive, real-time source always check Swissmedic and Fedlex directly.
How to Stay Up to Date
- Swissmedic news: swissmedic.ch/news
- Federal Gazette (Bundesblatt): fedlex.admin.ch — published Tuesday and Friday; contains proposed and enacted legislation
- MDCG updates: European Commission MDCG page — new MDCG guidance applicable in Switzerland
- RAPath CH Discussions: GitHub Discussions — community-sourced updates
Categories of Change to Monitor
Ordinance amendments — Changes to MedDO or IVDO text published via Federal Gazette and Fedlex. These are infrequent but significant.
New Swissmedic guidance — Swissmedic regularly publishes updated guidance documents, technical information sheets, and notices. Check the Swissmedic website guidance section.
MRA status changes — The CH–EU MRA Chapter 4 operational status can change with bilateral relations developments. See MRA Status Updates.
New MDCG guidance — New EU MDCG documents applicable in Switzerland are published by the European Commission. Monitor the MDCG guidance page.
Transitional provision deadlines — Key dates under MedDO/IVDO transitional provisions. See Transitional Timeline Tracker.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.