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 focus on ensuring compliance with Swiss regulations for companies looking to market their products in Switzerland.
**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 placing products on the Swiss market
* Guidance on Swiss Single Registration Number (CHRN) assignment
* Assistance with Medical Devices Ordinance (MedDO) amendments
**Reputation / proof points**
* Operates globally with offices and service centers in USA, UK, EU, and India, as well as specific locations in UAE, Canada, Mexico, Singapore, Malaysia, South Africa, and Sri Lanka.
* Leverages AI-first regulatory platform 'freya fusion' for compliance needs, covering the entire regulatory lifecycle.
* Offers a test drive of their AI Chatbot for instant regulatory answers.
Freyr (CH-Rep Services) is a provider specializing in Swiss Authorized Representative (CH-REP) services for medical device manufacturers. They focus on ensuring compliance with Swiss regulations for companies looking to market their products in Switzerland.
**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 placing products on the Swiss market
* Guidance on Swiss Single Registration Number (CHRN) assignment
* Assistance with Medical Devices Ordinance (MedDO) amendments
**Reputation / proof points**
* Operates globally with offices and service centers in USA, UK, EU, and India, as well as specific locations in UAE, Canada, Mexico, Singapore, Malaysia, South Africa, and Sri Lanka.
* Leverages AI-first regulatory platform 'freya fusion' for compliance needs, covering the entire regulatory lifecycle.
* Offers a test drive of their AI Chatbot for instant regulatory answers.
Additional information
Freyr (CH-Rep Services) assists economic operators domiciled in Switzerland with registering with Swissmedic to mitigate consequences arising from the absence of an updated Mutual Recognition Agreement (MRA) with the EU. Registration is required within three months of placing the first product on the Swiss market to prevent supply bottlenecks. They also provide support related to Swissmedic's new medical device regulations, including amendments to the Medical Devices Ordinance (MedDO) effective May 26, 2021, designed to ensure a sufficient supply of medical devices to Switzerland.
Key Highlights
-
Provides expert Swiss Authorized Representative (CH-REP) services.
Source
“Freyr (CH-Rep Services) provides expert Swiss Authorized Representative (CH-REP) services”
-
Offers regulatory support and liaises with Swissmedic.
Source
“They offer regulatory support, liaise with Swissmedic, and ensure compliance with Swiss regulations.”
-
Ensures compliance with Swiss regulations for medical device market entry.
Source
“ensure compliance with Swiss regulations.”
-
Assists with Swissmedic's new medical device regulations and MedDO amendments.
Source
“modifications/amendments made to the Medical Devices Ordinance (MedDO)”
-
Offers a global presence with service centers in multiple regions.
Source
“With Regional Delivery Centers, Client Servicing Centers and Offices in USA, UK, EU and India”
Certifications & Trust Signals
-
Leverages an AI-first regulatory platform, 'freya fusion', for compliance.
Source
“freya fusion is Freyr’s flagship AI-first regulatory platform, designed to meet complex, real-world compliance needs.”
-
Provides a chatbot for instant regulatory answers.
Source
“Test Drive , our AI Chatbot - get instant regulatory answers, free and live!”
Buyer Snapshot
Best for
- Medical device manufacturers seeking Swiss market access
- Companies needing to comply with Swiss MedDO regulations
- Businesses requiring a Swiss Authorized Representative
How engagement typically works
- End-to-end regulatory solutions
- AI-driven platform support
- Direct liaison with regulatory authorities
Typical deliverables
- CH-REP appointment
- Regulatory strategy and insights
- Dossier authoring
- Post-approval/lifecycle management
- Country-specific regulatory services
Good to know
- Best when requiring specific expertise in Swiss medical device regulations.
HQ:
Princeton, USA
Languages:
English, German, French
Timezones:
Europe/Zurich
Claim status:
Listed
Services & Capabilities
Find 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 (03) months of placing the first product on the Swiss market to avoid delays and prevent 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
TRUE
Swiss Local Contact
TRUE
Vigilance Contact Support
TRUE
Can Be Named On Label
TRUE
Swiss Entity Canton Or Region
CH
⚡ Instant booking available
Appoint a Swiss Authorized Representative (CH-REP) for Medical Devices
Compare Freyr (CH-Rep Services) and other vetted providers — instant pricing, no RFQ needed.
