The Crosswalk

    Swissmedic

    Flag of SwitzerlandSwitzerland - Swissmedic

    MandatoryLast updated · Mar 2026 (EU–Switzerland Bilaterals III package signed Mar 2 2026, incl. updated MRA covering medical devices; pending parliamentary ratification)Verified · 2026-07-16

    MedDO + Swissmedic guidance (mirrors EU MDR)

    Authority

    Swiss Agency for Therapeutic Products

    Enforced

    May 2021 (MedDO)

    Legal framework

    Medical Devices Ordinance (MedDO) + EU MDR alignment

    FDA package reuse

    ~55%

    Scope

    All medical devices placed on the Swiss market. Equivalent to EU MDR requirements following loss of MRA equivalence.

    Pre-market

    Equivalent to EU MDR Annex I §17.2; CH-REP (Swiss Authorised Representative) required.

    Post-market

    Vigilance via Swissmedic MIR forms; alignment with EU PMS.

    SBOM

    Recommended

    Mirrors EU expectations; CRA reporting (Sep 11 2026) and full compliance (Dec 11 2027) expected to apply via Bilaterals III once ratified.

    Vulnerability disclosure

    Aligned with EU expectations; NCSC.ch coordination.

    Penalty

    Market removal, criminal liability under Therapeutic Products Act.

    Unique requirements

    • 01CH-REP (Swiss Authorised Representative) on labelling
    • 02CHRN (Swiss single registration number)
    • 03German/French/Italian labelling

    Highlights

    • De-facto EU MDR equivalence
    • Needs Swiss AR (CH-REP)
    • MRA restoration package signed Mar 2 2026 (Bilaterals III); pending ratification by CH Parliament and EU - when in force, restores CE mutual recognition for the Swiss market

    Aligns with

    EU MDR IEC 81001-5-1 ISO 14971

    Timeline

    1. May 2021

      MedDO and IvDO enter force; MRA lapses

    2. Mar 2 2026

      EU–Switzerland Bilaterals III package signed, including updated MRA covering medical devices; subject to parliamentary ratification

    3. Mar 13 2026

      Swiss Federal Council adopts Bilaterals III dispatch and submits to Parliament for ratification

    Key documents

    Related markets

    Frequently asked about Switzerland

    Is SBOM required for medical devices in Switzerland?

    Recommended. Mirrors EU expectations; CRA reporting (Sep 11 2026) and full compliance (Dec 11 2027) expected to apply via Bilaterals III once ratified.

    What does Swissmedic require for pre-market cybersecurity?

    Equivalent to EU MDR Annex I §17.2; CH-REP (Swiss Authorised Representative) required.

    What are the post-market cybersecurity obligations under Swissmedic?

    Vigilance via Swissmedic MIR forms; alignment with EU PMS.

    What is the penalty for non-compliance with Swissmedic cybersecurity rules?

    Market removal, criminal liability under Therapeutic Products Act.

    How much of my FDA cybersecurity package is reusable in Switzerland?

    Roughly 55% - an editorial estimate based on overlapping evidence requirements (threat model, SBOM, security risk assessment, pen-test report).