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 of Swiss Authorized Representative (CH-REP) services, assisting medical device manufacturers in navigating the Swiss market. They offer regulatory support and 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
* Assistance with Swiss Single Registration Number (CHRN) assignment
* Reporting of serious incidents and Field Safety Corrective Actions (FSCA) to Swissmedic
* Guidance on clinical trials for medical devices under Swiss regulations
* Support for medical device regulations, including MedDO amendments
**Reputation / proof points**
* Leverages AI-first regulatory platform 'freya fusion' grounded in over 15 years of regulatory expertise.
* Operates with regional delivery centers, client servicing centers, and offices in USA, UK, EU, and India.
Freyr (CH-Rep Services) is a provider of Swiss Authorized Representative (CH-REP) services, assisting medical device manufacturers in navigating the Swiss market. They offer regulatory support and 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
* Assistance with Swiss Single Registration Number (CHRN) assignment
* Reporting of serious incidents and Field Safety Corrective Actions (FSCA) to Swissmedic
* Guidance on clinical trials for medical devices under Swiss regulations
* Support for medical device regulations, including MedDO amendments
**Reputation / proof points**
* Leverages AI-first regulatory platform 'freya fusion' grounded in over 15 years of regulatory expertise.
* Operates with regional delivery centers, client servicing centers, and offices in USA, UK, EU, and India.
Additional information
Freyr (CH-Rep Services) provides comprehensive support for medical device manufacturers entering the Swiss market. They address the complexities of Swissmedic's regulations, including the Medical Devices Ordinance (MedDO) and its amendments. Key areas of support include obtaining the Swiss Single Registration Number (CHRN) and managing incident reporting and Field Safety Corrective Actions (FSCA) in compliance with Swiss requirements. Their services are designed to ensure a sufficient supply of medical devices to Switzerland and mitigate the consequences of regulatory changes.
Key Highlights
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Provides expert Swiss Authorized Representative (CH-REP) services.
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 and liaises with Swissmedic.
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 and 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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Supports the assignment of 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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Provides support for reporting 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 with over 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.”
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Maintains offices and centers in USA, UK, EU, and India.
Source
“With Regional Delivery Centers, Client Servicing Centers and Offices in USA, UK, EU and India”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access
- Companies needing regulatory representation in Switzerland
How engagement typically works
- Regulatory support and liaison
- Compliance assurance
Typical deliverables
- CH-REP services
- Swissmedic liaison
- Regulatory compliance guidance
- Incident reporting support
Good to know
- Best when requiring a dedicated Swiss Authorized Representative for medical devices.
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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