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 consultancy focused on regulatory compliance for medical devices and IVDs. They provide expert services as an EU and Swiss Authorized Representative.
**Expertise & scope**
* EU Authorized Representative (EC-REP) functions
* Swiss Authorized Representative (CH-REP) functions
* Regulatory compliance for medical devices
* Regulatory compliance for In Vitro Diagnostic Devices (IVDs)
**Reputation / proof points**
* Coverage: Switzerland (CH)
Metecon Switzerland GmbH is a specialized consultancy focused on regulatory compliance for medical devices and IVDs. They provide expert services as an EU and Swiss Authorized Representative.
**Expertise & scope**
* EU Authorized Representative (EC-REP) functions
* Swiss Authorized Representative (CH-REP) functions
* Regulatory compliance for medical devices
* Regulatory compliance for In Vitro Diagnostic Devices (IVDs)
**Reputation / proof points**
* Coverage: Switzerland (CH)
Additional information
Metecon Switzerland GmbH focuses on ensuring that medical devices and IVDs meet the stringent regulatory requirements for market access in both the European Union and Switzerland. Their role as an Authorized Representative is critical for manufacturers outside these regions, acting as a local point of contact and ensuring ongoing compliance with relevant directives and regulations. Buyers should consider the specific scope of their product portfolio and the target markets when engaging Metecon for CH-REP or EC-REP services.
Key Highlights
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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
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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
- Manufacturers of medical devices and IVDs seeking Swiss market access
- Companies needing a dedicated CH-REP
How engagement typically works
- Direct engagement for regulatory representation
- Focus on compliance documentation and liaison
Typical deliverables
- Designation as Swiss Authorized Representative (CH-REP)
- Support for regulatory compliance documentation
- Liaison with Swiss Competent Authorities
Good to know
- Best when focused on Swiss market entry and ongoing compliance for medical devices and IVDs.
HQ:
Bern, CH
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:
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
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