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How to Read Swiss Legislation

Swiss federal legislation is published and consolidated on Fedlex (fedlex.admin.ch). Understanding how Swiss law is organised and how to locate the current, consolidated text of a specific statute or ordinance is essential for anyone working in 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.

Official Sources​

Swissmedic Guidance Documents​

Swissmedic publishes guidance documents that provide interpretation and practical guidance on MedDO, IVDO, and ClinO-MD requirements. While not legally binding, these documents represent Swissmedic's current regulatory interpretation and are important for compliance planning. Key guidance documents are available on the Swissmedic website (www.swissmedic.ch) and cover topics such as:

  • Classification decisions
  • Conformity assessment procedures
  • Clinical evaluation and PMCF
  • Notified body designation and oversight
  • Post-market surveillance

For any interpretation question, it is prudent to consult relevant Swissmedic guidance alongside the statutory text.