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Switzerland

Aligning with Swiss Medical Device Regulations

Switzerland, with its nearly 9 million population, is recognized for its robust medical technology sector, bolstered by strong fundamentals and political stability. The Mutual Recognition Agreement (MRA) between the European Union and Switzerland has been impacted by the EU's new medical devices (MDR) and IVDs (IVDR) regulations, necessitating separate compliance for devices intended for the Swiss market through the Medical Devices Ordinance (MDO).

Device Classification and Regulatory Pathways

Meeting Swissmedic Requirements

Regulatory Authority

Switzerland has adopted the Medical Devices Ordinance (MDO), closely mirroring the EU's MDR and IVDR, to ensure the safety and efficacy of medical devices within its borders. Despite the recognition of CE marking, registration with Swissmedic is required, marking a significant regulatory requirement for market access.

Classification

The classification of medical devices in Switzerland follows the EU's system, where it is based on the device's intended use and associated risk. This classification determines the specific registration and compliance requirements with Swissmedic.

Key Requirements

To market medical devices in Switzerland, manufacturers outside of Switzerland must:

  • Appoint a Swiss Authorized Representative (Swiss AR or CH REP) to act on their behalf. The Swiss AR is responsible for ensuring the manufacturer reports vigilance to Swissmedic.
  • Ensure pre-market registration and compliance with the MDO, facilitated by the Swiss AR.
How We Can Help

Tailored Support for Market Entry

Our services are designed to streamline your entry into the Swiss medical device market:

  • Guidance on device classification and determination of the appropriate regulatory pathway under the MDO.

  • Acting as your Swiss Authorized Representative, managing pre-market registration and ensuring ongoing compliance with Swissmedic requirements.

We Provide Access To 28+ Markets Worldwide

Our team of experts and local representatives, supported by partnerships with hundreds of clinical labs and the extensive GRIP database for over 100 countries, accelerates product launches and ensures compliance across 28 countries.

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