Key provisions
Swissmedic can grant temporary market access if:
- The device has FDA, CE, or Health Canada certification.
- It treats life-threatening conditions.
- No alternatives exist domestically.
- Temporary access is valid for 6–18 months (renewable).
Manufacturers must present a risk assessment and PMS plan (per MDR Article 83). Only Swiss-authorized distributors may supply the device.
Eligible device types
- Class III implants (orthopedic, cardiologic).
- Oncology treatment systems.
- Intensive care and respiratory support devices.
- IVDs for critical diagnoses (e.g., sepsis, HIV, SARS-CoV-2, RSV, influenza).
MDR Regulation comparison
| Feature | MDR Requirement | Swiss Fast-Track |
| CE Certificate | Required | Accepts FDA/HC equivalence |
| Clinical Evaluation | Annex XIV mandatory | Abbreviated acceptable |
| Validity | Up to 5 years | 6–18 months |
| PMS/FSCA | Required | Required (simplified reporting) |
Implications for EU policy
This regulatory model sets a precedent for flexible solutions under crisis. It could inspire the EU to launch a “fast track” for orphan/critical-use devices. FDA-certified manufacturers may now access Europe via the Swiss market.
Manufacturer action steps:
- Consider Swissmedic application if your product lacks MDR/IVDR certification.
- Prepare clinical documentation and PMS plans for Swiss review.
- Appoint a Swiss-based Authorized Representative.
Źródło: Federal Council press release