Freyr (CH-Rep Services)
Freyr (CH-Rep Services) provides expert Swiss Authorized Representative (CH-REP) services for medical device manufacturers seeking to market their products in Switzerland. They offer regulatory support, liaise with Swissmedic, and ensure compliance with Swiss regulations.
Freyr (CH-Rep Services) is a specialized provider of Swiss Authorized Representative (CH-REP) services, essential for medical device manufacturers looking to access the Swiss market. They offer comprehensive regulatory support, including appointing a CH-REP, representing devices in Switzerland, and liaising directly with Swissmedic on your behalf. Their services ensure your medical devices meet all necessary compliance requirements for registration and marketing. With a strong understanding of Swissmedic's regulations, including recent amendments to the Medical Devices Ordinance (MedDO), Freyr helps navigate the complexities of market access. They provide guidance on unique identification numbers (CHRN), reporting of incidents and field safety corrective actions (FSCA), and clinical trial requirements. Freyr's expertise extends to reviewing technical files for compliance and ensuring your labeling meets Swiss standards. Freyr offers a free 30-minute consultation to discuss your specific needs and provides step-by-step guidance throughout the process. Their commitment is to facilitate a smooth and compliant entry into the Swiss market for your medical and in-vitro devices.
About
**Who they are**
Freyr (CH-Rep Services) is a provider specializing in Swiss Authorized Representative (CH-REP) services for medical device manufacturers. They offer regulatory support to ensure compliance with Swiss regulations.
**Expertise & scope**
* Expert Swiss Authorized Representative (CH-REP) services
* Regulatory support for medical device manufacturers
* Liaison with Swissmedic
* Ensuring compliance with Swiss regulations
* Support for Swissmedic's new medical device regulations, including MedDO amendments
* Guidance on Unique Identification Number (CHRN) assignment and registration with Swissmedic
* Assistance with reporting incidents and Field Safety Corrective Actions (FSCA) to Swissmedic
* Information on clinical trials of medical devices under Swiss regulations
* Leveraging the AI-first regulatory platform, freya fusion, for complex compliance needs across the regulatory lifecycle.
**Reputation / proof points**
* Provider of expert Swiss Authorized Representative (CH-REP) services
* Offers regulatory support, liaises with Swissmedic, and ensures compliance with Swiss regulations.
* Utilizes freya fusion, an AI-first regulatory platform with over 15 years of regulatory expertise.
Freyr (CH-Rep Services) is a provider specializing in Swiss Authorized Representative (CH-REP) services for medical device manufacturers. They offer regulatory support to ensure compliance with Swiss regulations.
**Expertise & scope**
* Expert Swiss Authorized Representative (CH-REP) services
* Regulatory support for medical device manufacturers
* Liaison with Swissmedic
* Ensuring compliance with Swiss regulations
* Support for Swissmedic's new medical device regulations, including MedDO amendments
* Guidance on Unique Identification Number (CHRN) assignment and registration with Swissmedic
* Assistance with reporting incidents and Field Safety Corrective Actions (FSCA) to Swissmedic
* Information on clinical trials of medical devices under Swiss regulations
* Leveraging the AI-first regulatory platform, freya fusion, for complex compliance needs across the regulatory lifecycle.
**Reputation / proof points**
* Provider of expert Swiss Authorized Representative (CH-REP) services
* Offers regulatory support, liaises with Swissmedic, and ensures compliance with Swiss regulations.
* Utilizes freya fusion, an AI-first regulatory platform with over 15 years of regulatory expertise.
Additional information
Freyr (CH-Rep Services) provides comprehensive support for medical device manufacturers navigating the Swiss market. They assist with understanding and implementing new regulations, such as the MedDO amendments effective May 26, 2021. This includes guidance on obtaining the Swiss Single Registration Number (CHRN) and meeting the three-month registration deadline after placing a product on the Swiss market. They also support manufacturers in reporting serious incidents and Field Safety Corrective Actions (FSCA) to Swissmedic, even in the absence of EUDAMED access, to ensure patient safety and market surveillance.
Key Highlights
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Provides expert Swiss Authorized Representative (CH-REP) services for medical device manufacturers.
Source
“Freyr (CH-Rep Services) provides expert Swiss Authorized Representative (CH-REP) services for medical device manufacturers seeking to market their products in Switzerland.”
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Offers regulatory support, liaises with Swissmedic, and ensures compliance with Swiss regulations.
Source
“They offer regulatory support, liaise with Swissmedic, and ensure compliance with Swiss regulations.”
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Assists with Swissmedic's new medical device regulations, including MedDO amendments.
Source
“You might be aware, in the context of pending agreements between Switzerland and the EU, there are certain modifications/amendments made to the Medical Devices Ordinance (MedDO)”
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Provides guidance on obtaining the Swiss Single Registration Number (CHRN).
Source
“Upon request, Swissmedic assigns the Swiss Single Registration Number (CHRN) to Swiss manufacturers, authorized representatives and importers.”
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Supports reporting of incidents and Field Safety Corrective Actions (FSCA) to Swissmedic.
Source
“In Switzerland, the incidents that have occurred and are classed as serious must be reported to Swissmedic, even in the absence of access to EUDAMED3.”
Certifications & Trust Signals
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Leverages freya fusion, an AI-first regulatory platform grounded in 15+ years of regulatory expertise.
Source
“freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs. Grounded in 15+ years of regulatory expertise and driven by advanced AI/ML.”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss Authorized Representation
- Companies needing to comply with Swissmedic regulations
How engagement typically works
- Regulatory support and liaison
- Compliance guidance
Typical deliverables
- CH-REP services
- Regulatory strategy and insights
- Post-approval/lifecycle management
- Country-specific regulatory services
Good to know
- Best when engaging with Swissmedic and understanding Swiss medical device regulations is critical.
HQ:
Princeton, USA
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Best CH-REP (Swiss Authorized Rep) | Compare & Get Quotes
Jurisdictions:
CH
Countries:
CH
Industries:
Medical devices, IVD
Portfolio:
100+
Onboarding time:
1–5 days
Pricing model:
Retainer
Starting from:
CHF 3,500
Included services:
Swissmedic contact point handling, Vigilance and incident reporting coordination, Labeling/packaging CH-REP information alignment, Mandate administration and documentation availability
Device Classes Supported:
Class I, Class IIa, Class IIb, Class III, IVD
Swiss Local Contact:
Yes
Labeling Support:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Swiss Entity Canton Or Region:
CH
Additional ch_rep Details
Included Services Detailed
Initial portfolio intake and mandate setup for Swiss representation, Operational workflow for Swissmedic queries and manufacturer responses, Support for labeling text placement adjacent to the CH-REP symbol and address details, Coordination of vigilance reporting and field safety corrective actions
Excluded Services
Notified Body certification services, Legal representation in disputes, Distributor commercial management
Onboarding Steps
Requires registration with Swissmedic within three months of placing the first product on the Swiss market to avoid delays and supply bottlenecks.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Supports MDR
true
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
Swiss Entity Canton Or Region
CH
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