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.

Red pill with white Swiss cross symbol representing Swiss pharmaceutical or healthcare industry, placed among other medical capsules.

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

CONTACT US