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; will follow CRA timeline through bilateral arrangements.
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)
- Watch for MRA renegotiation impacts
Aligns with
Timeline
-
May 2021
MedDO and IvDO enter force; MRA lapses
-
2024
Recognition of FDA approvals discussed
Key documents
Related markets
Frequently asked about Switzerland
Is SBOM required for medical devices in Switzerland?
Recommended. Mirrors EU expectations; will follow CRA timeline through bilateral arrangements.
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).