Switzerland implements simplified market access pathway for high-risk medical devices

In May 2025, the Swiss Federal Council amended national medical device legislation, introducing a fast-track authorization mechanism for high-risk products that lack standard conformity. This pilot scheme responds to access issues caused by MDR/IVDR certification shortages and may become permanent.

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