Due to the lack of a Mutual Recognition Agreement (MRA) with the EU since 2021, Switzerland has implemented its own regulatory framework for medical devices. While talks to update the MRA with the EU are ongoing, Switzerland has been discussing the possibility to accept conform medical devices from other countries, too.
Switzerland to strengthen its supply with FDA-approved devices
In 2022, a parliamentary motion called for measures to permit medical devices from non-European regulatory systems to be placed on the market in Switzerland. Since then, Switzerland has been considering allowing FDA-approved devices into its market to diversify supply sources and ease access to innovative products.
It is likely that FDA-approved devices would undergo an additional, simplified review by the Swiss private bodies. Compliance with Swiss requirements concerning data protection or a quality management system, post-marketing surveillance plan and request of clinical evidence could be implemented as well.
Swiss Medtech calls for fast approval
In April 2025, Swiss Medtech issued a call for Switzerland to advance with the recognition of FDA-approved medical devices. In this statement, Swiss Medtech emphasises that this would improve patient care, stimulate innovation, and strengthen Switzerland’s position as a leading hub for medical technology. Allowing such devices could also enhance Switzerland’s attractiveness as a destination for global medtech companies, serving as a strategic entry point into the European market.
Compliance with Swiss requirements medical devices
Switzerland remains an attractive market for companies from the EU and around the world. Although it has developed its own regulatory framework, the country continues to recognise conformity assessments conducted under the EU Medical Device Regulations (MDR and IVDR). This continued reliance helps maintain strong regulatory alignment and close ties between Switzerland and the EU.
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Regulatory Intelligence & Innovation
09/05/2025
Reference:
Swiss Federal Council (2025). The Federal Council defines guidelines for expanding the supply of medical devices. Retrieved on 09/05/2025.
Swiss Medtech (2025). Ein kluger Entscheid für Patientinnen und Patienten, Innovation und Standortattraktivität. Retrieved on 09/05/2025.
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