How Can Freyr help?
Freyr offers multiple and flexible service models to choose from, based on the manufacturer or importer, or distributor requirements.
- Freyr acting as a Swiss AR (Authorized Representative)
- Freyr’s Swiss AR (Authorized Representative) Toolkit
Freyr Expertise
Freyr is a leading global Regulatory solutions and services provider specializing in Medical Devices Regulatory support. Freyr is poised as the go-to Swiss Agent Services provider with end-to-end Regulatory support for registering and marketing your Medical and In-Vitro Devices in Switzerland.
Freyr Advantages
- Dedicated single point of client service contact
- Highly qualified professionals as Swiss Agents delivering compliance-oriented comprehensive services
- Tailor-made services as per the client’s requirements
- Saving valuable time for businesses considering quick set-up service
- Offering industry-standard economic solutions for healthcare businesses
Swiss Distributor/Importer
The distributor of medical devices approved under the EU MDR or the EU MDD/AIMDD and the EU IVDR or the EU IVDDD do not have to register themselves or obtain a CHRN number with Swissmedic. The importers of devices certified under the EU MDD/AIMDD/IVDDD and who have placed their devices in the Swiss market before May 26, 2021, also need not register themselves or obtain a CHRN number with Swissmedic.
The importers of devices certified under the EU MDR, or the EU MDD/AIMDD, the EU IVDR, or the EU IVDDD and who have placed their devices for the first time in the Swiss market after May 26, 2021, and May 26, 2022 (respectively), must register themselves within three (03) months of placing the device in Switzerland.
The importers of devices certified under the EU MDR and who have placed their devices for the first time in the Swiss market before May 26, 2021, were required to register by November 26, 2021.
The importers of IVDs certified under the EU IVDR and who have placed their devices for the first time in the Swiss market before May 26, 2022, were required to register by November 26,2022.
