Key Provisions of the Federal Council Regulation

Swissmedic, the Swiss Agency for Therapeutic Products, may now temporarily authorize high-risk medical devices if the following conditions are met:

  • The product holds FDA (USA), CE (EU), or Health Canada certification.

  • It is used to treat life-threatening conditions.

  • No equivalent alternatives are available on the Swiss market.

The temporary authorization can be granted for 6 to 18 months, with the option of extension.
The manufacturer must document a risk assessment and implement a Post-Market Surveillance (PMS) plan in line with Article 83 MDR.
Products must be placed on the market only through authorized distributors based in Switzerland.

Types of Medical Devices Covered by the New Pathway

  • Orthopedic and cardiac implants (Class III),

  • Devices for cancer therapy,

  • Systems for intensive care and respiratory support,

  • In vitro diagnostics (IVDs) used in critical indications such as sepsis, HIV, SARS-CoV-2, RSV, and influenza A/B.

Differences Compared to MDR/IVDR

Category MDR Simplification in Switzerland
CE Certificate Mandatory Can be replaced by FDA/Health Canada approval
Clinical Evaluation Mandatory (Annex XIV) Abbreviated version allowed
Validity Period Up to 5 years Up to 18 months
PMS/FSCA Mandatory Mandatory, but with simplified reporting

Impact on the European Market

Although these changes apply only to Switzerland, they may have broader implications:

  • They establish a precedent for regulatory flexibility in response to supply shortages.

  • They could inspire the European Commission to develop a similar “fast-track” mechanism for orphan and critical devices within the EU.

  • They allow manufacturers with FDA certification to enter the European market via Switzerland as an initial step.

What Manufacturers Should Do

  • If your product is certified outside the EU and not yet MDR/IVDR compliant, consider applying to Swissmedic under the new pathway.

  • Prepare clinical documentation and PMS reports ready for review under the simplified procedure.

  • Contact a local authorized representative in Switzerland to handle market access and regulatory representation.

Source: Federal Council Press Release