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How to Read Swiss Legislation

Overview​

Swiss legislation is published and consolidated on Fedlex (fedlex.admin.ch). Understanding how Swiss law is organised and how to find the current, consolidated text of a specific ordinance is an essential skill for anyone working with Swiss medical device regulation.

The SR Number System​

Every Swiss federal law and ordinance has an SR number (Systematische Rechtssammlung — Systematic Collection of Law). The SR number is a unique identifier for each piece of legislation:

  • SR 812.21 — Therapeutic Products Act (TPA)
  • SR 812.213 — Medical Device Ordinance (MedDO)
  • SR 812.219 — IVD Ordinance (IVDO)
  • SR 810.305 — Clinical Investigations Ordinance (ClinO-MD)

To find any legislation: go to fedlex.admin.ch, enter the SR number in the search, and select the current consolidated version.

Fedlex — The Official Source​

Fedlex (fedlex.admin.ch) is the official Swiss federal legal publication platform. Key features:

  • All consolidated federal legislation in German, French, and Italian (the three official legislative languages)
  • Many key instruments also available in English (unofficial but useful translation)
  • Version history — you can view legislation as it read at any point in time
  • RSS feeds for amendments and new legislation

Official vs Unofficial Languages​

Swiss federal legislation is legally authoritative in German, French, and Italian. English translations are provided as a service but are not legally binding. For any regulatory compliance question, always verify against the authoritative German, French, or Italian text.

  1. Federal Constitution — supreme law
  2. Federal Acts (Bundesgesetze) — adopted by Parliament (e.g. TPA)
  3. Ordinances (Verordnungen) — issued by Federal Council or departments (e.g. MedDO, IVDO)
  4. Guidance documents — issued by Swissmedic; not legally binding but represent Swissmedic's operational interpretation

Official Sources​

Disclaimer

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