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 provider of expert regulatory compliance services.
**Expertise & scope**
* Specializes in EU and Swiss Authorized Representative functions.
* Focuses on medical devices and In Vitro Diagnostic (IVD) devices.
* Offers services for both EC-REP and CH-REP requirements.
**Reputation / proof points**
* Coverage: Switzerland (CH)
Metecon Switzerland GmbH is a provider of expert regulatory compliance services.
**Expertise & scope**
* Specializes in EU and Swiss Authorized Representative functions.
* Focuses on medical devices and In Vitro Diagnostic (IVD) devices.
* Offers services for both EC-REP and CH-REP requirements.
**Reputation / proof points**
* Coverage: Switzerland (CH)
Additional information
Metecon Switzerland GmbH provides specialized services for manufacturers seeking to place medical devices and IVDs on the Swiss market. Their expertise as a Swiss Authorized Representative (CH-REP) ensures that foreign manufacturers can meet local regulatory obligations. This includes acting as a local point of contact for Swiss authorities and consumers, facilitating communication, and ensuring compliance with Swiss regulations. Engaging Metecon can streamline the market access process for devices requiring a CH-REP designation.
Key Highlights
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Specializes in Swiss Authorized Representative (CH-REP) functions.
Source
“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.”
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Provides services for both medical devices and IVDs.
Source
“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.”
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Offers services in English, German, and French.
Source
“Languages: English, German, French”
Certifications & Trust Signals
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Established provider of regulatory compliance services.
Source
“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.”
Buyer Snapshot
Best for
- Manufacturers of medical devices and IVDs needing a Swiss Authorized Representative (CH-REP).
How engagement typically works
- Direct engagement for regulatory representation.
Typical deliverables
- Designation as Swiss Authorized Representative (CH-REP).
- Local point of contact for Swiss authorities and consumers.
- Support for regulatory compliance in Switzerland.
Good to know
- Best when requiring a dedicated entity for Swiss market compliance.
HQ:
Bern, CH
Languages:
English, German, French
Timezones:
Europe/Zurich
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
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
Yes
Vigilance Contact Support
true
Can Be Named On Label
true
Supports MDR
true
Supports IVDR
true
