Swissmedic
Switzerland - Swissmedic
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
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
RecommendedMirrors 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
Timeline
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May 2021
MedDO and IvDO enter force; MRA lapses
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Mar 2 2026
EU–Switzerland Bilaterals III package signed, including updated MRA covering medical devices; subject to parliamentary ratification
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Mar 13 2026
Swiss Federal Council adopts Bilaterals III dispatch and submits to Parliament for ratification
Key documents
How to submit in Switzerland
Playbook reviewed · 2026-07-16
Submission route
Swissmedic notification under MedDO with Swiss AR
Post-MRA-lapse, Swiss requirements track EU MDR with a Swiss Authorised Representative and separate Swissmedic registration.
Authority portalStep-by-step
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Step 01
Appoint local representation
Most jurisdictions require a locally-established entity to hold the registration or act as authorised representative before submission.
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Step 02
Reuse FDA or CE package as baseline
Adapt the cybersecurity subsection you already prepared for FDA or CE; regulators here typically accept the structure and ask for local labeling additions.
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Step 03
Translate and localise
Local-language technical summary and labeling are usually mandatory; certified translation is safest.
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Step 04
Submit + track queries
Respond to clarification rounds promptly; each unanswered question can add 30-90 days to the clock.
Evidence checklist
| Item | Level | FDA equivalent | Notes |
|---|---|---|---|
| Cybersecurity documentation (baseline FDA or CE) | Required | SPDF | |
| Local authorised representative agreement | Required | — | |
| Local-language labeling and IFU | Required | — | |
| SBOM | Recommended | — | Not mandatory but reduces clarification rounds. |
Common Swissmedic rejections
No CH-REP on labeling
CommonFix · Add Swiss AR name and address to labeling and IFU.
Typical timeline
End-to-end window: 1-3 months post-CE
Phase 01
Local rep + dossier prep
2-4 months
Phase 02
Regulatory review
1-3 months post-CE
Phase 03
Approval + market entry
1-3 months
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).