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 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
* Services cover medical devices and In Vitro Diagnostic (IVD) devices
* Coverage includes Switzerland (CH)

**Reputation / proof points**
* Languages spoken: English, German, French

Additional information

Metecon Switzerland GmbH provides essential functions for manufacturers seeking to place medical devices and IVDs on the Swiss market. As the Swiss Authorized Representative (CH-REP), they act as a local point of contact for regulatory authorities and are responsible for ensuring compliance with Swiss regulations, including the Medical Devices Ordinance (MepV). This role is critical for non-Swiss manufacturers who need a legal entity within Switzerland to manage their market access. Their services ensure that devices meet local requirements, facilitating smoother market entry and ongoing compliance.

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
  • Non-Swiss manufacturers of medical devices and IVDs
  • Companies seeking CH-REP services
How engagement typically works
  • Regulatory consultancy
  • Local representation
Typical deliverables
  • CH-REP appointment
  • Regulatory compliance support for the Swiss market
Good to know
  • Best when requiring a Swiss Authorized Representative for market access.
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
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