Metecon Switzerland GmbH
Metecon Switzerland GmbH offers expert regulatory compliance services, specializing in EU and Swiss Authorized Representative (EC-REP & CH-REP) functions for medical devices and IVDs.
Metecon Switzerland GmbH is a specialized consultancy focused on providing comprehensive regulatory compliance solutions for medical devices and in-vitro diagnostics (IVDs). They offer crucial services as an EU Authorized Representative (EC-REP) to facilitate market access within the European Union and as a Swiss Authorized Representative (CH-REP) for the Swiss market. Their expertise covers navigating complex regulations such as MDR, IVDR, MepV, and IvDV, ensuring that manufacturers meet all necessary requirements for product registration and compliance. Metecon aims to simplify the compliance journey for their clients, offering a 360° approach to regulatory affairs. With a strong emphasis on both European and Swiss market access, Metecon Switzerland GmbH positions itself as a reliable partner for companies seeking to successfully launch and maintain their products in these key regions. They provide guidance and support throughout the entire compliance lifecycle.
About
**Who they are**
Metecon Switzerland GmbH is a specialized provider of regulatory compliance services, focusing on the EU and Swiss Authorized Representative functions. They are based in Switzerland.
**Expertise & scope**
* Expert regulatory compliance services
* Specialization in EU Authorized Representative (EC-REP) functions
* Specialization in Swiss Authorized Representative (CH-REP) functions
* Focus on medical devices and In Vitro Diagnostic Devices (IVDs)
**Reputation / proof points**
* Coverage: Switzerland (CH)
Metecon Switzerland GmbH is a specialized provider of regulatory compliance services, focusing on the EU and Swiss Authorized Representative functions. They are based in Switzerland.
**Expertise & scope**
* Expert regulatory compliance services
* Specialization in EU Authorized Representative (EC-REP) functions
* Specialization in Swiss Authorized Representative (CH-REP) functions
* Focus on medical devices and In Vitro Diagnostic Devices (IVDs)
**Reputation / proof points**
* Coverage: Switzerland (CH)
Additional information
Metecon Switzerland GmbH assists manufacturers of medical devices and IVDs in meeting their regulatory obligations for placing products on the Swiss market. As a Swiss Authorized Representative, they act as a local point of contact for authorities and consumers, ensuring compliance with Swiss regulations. Their services are crucial for companies looking to access the Swiss market without having a physical presence within the country.
Key Highlights
-
Specializes in EU and Swiss Authorized Representative functions
Source
“specializing in EU and Swiss Authorized Representative (EC-REP & CH-REP) functions”
-
Covers medical devices and IVDs
Source
“for medical devices and IVDs”
-
Offers services in English, German, and French
Source
“Languages: English, German, French”
Certifications & Trust Signals
-
Established Swiss Authorized Representative provider
Source
“Metecon Switzerland GmbH offers expert regulatory compliance services, specializing in EU and Swiss Authorized Representative (EC-REP & CH-REP) functions”
Buyer Snapshot
Best for
- Medical device and IVD manufacturers seeking Swiss market access
- Companies requiring a dedicated CH-REP
How engagement typically works
- Formal service agreement
- Ongoing regulatory support
Typical deliverables
- Designation as Swiss Authorized Representative (CH-REP)
- Local point of contact for Swiss authorities
- Support with Swiss regulatory compliance
Good to know
- Best when a dedicated CH-REP is required for market entry or continued compliance in Switzerland.
HQ:
Bern, CH
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:
26-100
Onboarding time:
1–5 days
Pricing model:
Onboarding + annual retainer
Starting from:
CHF 2,500
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:
IVD
Swiss Local Contact:
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 manufacturers to provide detailed technical documentation and information about their quality management systems.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Swiss Entity Canton Or Region
CH
Labeling Support
true
Swiss Local Contact
true
Vigilance Contact Support
true
Can Be Named On Label
true
Supports MDR
true
Supports IVDR
true
⚡ Instant booking available
Appoint a Swiss Authorized Representative (CH-REP) for Medical Devices
Compare Metecon Switzerland GmbH and other vetted providers — instant pricing, no RFQ needed.
