Medical Device Regulation in Switzerland
Switzerland regulates medical devices through Swissmedic under the Medical Devices Ordinance (MedDO, SR 812.213), substantially revised in 2021 to align with EU MDR 2017/745. CE marking is the primary route to Swiss market access. A Mutual Recognition Agreement (MRA) with the EU is under negotiation.
Device Classification
Identical classification system to EU MDR 2017/745. Class I: low risk, self-declaration. Class IIa/IIb: medium risk, Notified Body/Swiss Approved Body involvement required. Class III: high risk, strictest conformity assessment. Classification rules mirror Annex VIII of EU MDR.
Official classification guidance →Standards & Key Principles
Applicable Standards
Key Principles
- MedDO substantially aligned with EU MDR 2017/745
- CE marking (EU Notified Body) accepted as basis for Swiss market access
- Swiss Authorized Representative required for foreign manufacturers
- Registration in Swissmedic database mandatory before market placement
- Vigilance reporting to Swissmedic (separate from EU EUDAMED for now)
Pre-Market Requirements
Devices with EU MDR CE marking placed on Swiss market. Swiss Authorized Representative must be appointed and device registered with Swissmedic.
For devices without EU CE marking: conformity via Swiss-designated Approved Bodies. Same technical requirements as EU MDR.
Mandatory registration in Swissmedic database before market placement, including device ID, Authorized Representative, and conformity assessment certificates.
Post-Market Requirements
Serious incidents reported to Swissmedic: 2 days for life-threatening, 10 days for death/serious injury, 30 days for others.
Aligned with EU MDR; manufacturers maintain PMS system and submit PSUR to Notified Body per EU MDR timelines.
International Recognition & Reliance
CE marking under EU MDR is the primary basis for Swiss market access; MedDO aligned with MDR 2017/745.