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The Swiss MedTech Landscape

Since May 2021, Switzerland’s MRA with the EU is no longer applicable, posing potential challenges to the availability of medical products in the long term. To address this situation and avoid potential shortages of medical products, Switzerland has initiated the process of establishing mutual recognition agreements with other regions.

FDA Publishes Updated Guidance for Breakthrough Devices Program

On September 15, 2023, the U.S. Food and Drug Administration (FDA) updated and posted the Final Guidance for Industry and Food and Drug Administration Staff: Breakthrough Devices Program. This guidance updates the previous version of the guidance, of the same title, issued on December 18, 2018.

FDA Announces Three New Guidances Dedicated to 510(k) Submissions

On September 6, 2023, the U.S. Food and Drug Administration (FDA) released a statement about the issuance of the three new guidances as part of their effort to strengthen and modernize the 510(k) Program and advance the safety and effectiveness of medical devices.

Mechanical Hemolysis Assay for Blood Contacting Devices

The Mechanical Hemolysis Assay is an in vitro test used to assess the potential for red blood cell damage by comparing the hemolytic effects of test articles with a reference device to determine their compatibility with blood contact.