Skip to main content

New Swissmedic Guidance Published

Overview​

Swissmedic regularly publishes new guidance documents, technical information sheets, and notices relating to medical device regulation. This page tracks newly published guidance and explains how to stay up to date.

info

For the definitive, real-time list of new Swissmedic guidance, always check the Swissmedic website directly.

How to Monitor New Swissmedic Guidance​

  • Swissmedic news and publications: swissmedic.ch/news — Swissmedic publishes notices of new guidance on its news page
  • Swissmedic guidance section: swissmedic.ch — medical devices guidance — browse the full guidance library by topic
  • Swissmedic newsletter: Swissmedic offers a newsletter subscription service for regulatory updates
  • MDCG new guidance: European Commission MDCG page — new MDCG guidance is typically applicable in Switzerland soon after publication

Categories of Swissmedic Guidance​

Technical information sheets (Merkblätter/Fiches techniques) — Short documents clarifying specific requirements or processes. Typically available in German, French, and Italian; sometimes also in English.

Guidance documents — Longer documents providing detailed interpretive guidance on MedDO/IVDO requirements. Often aligned with or referencing MDCG guidance.

FAQ documents — Answers to frequently asked questions about specific regulatory topics (registration, vigilance reporting, DAPI processes).

Circular notices (Rundschreiben) — Formal notifications to industry about regulatory changes or requirements.

What to Do When New Guidance Is Published​

  1. Assess whether the guidance is relevant to your device portfolio
  2. Evaluate whether the guidance changes any existing compliance positions in your technical documentation or quality system
  3. Update affected procedures, work instructions, or templates accordingly
  4. For significant new guidance: assess whether existing NB-certified technical documentation needs updating

Official Sources​

Disclaimer

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