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
May 2021
MedDO and IvDO enter force; MRA lapses
Mar 2 2026
EU–Switzerland Bilaterals III package signed, including updated MRA covering medical devices; subject to parliamentary ratification
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
Step 01
Appoint local representation
Most jurisdictions require a locally-established entity to hold the registration or act as authorised representative before submission.
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.
Step 03
Translate and localise
Local-language technical summary and labeling are usually mandatory; certified translation is safest.
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 |
|---|---|
| Cybersecurity documentation (baseline FDA or CE) | Required |
| Local authorised representative agreement | Required |
| Local-language labeling and IFU | Required |
| SBOM | Recommended |
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).