MDSS
MDSS GmbH
MDSS is a trusted Authorized Representative and Regulatory Affairs specialist for Medical and In Vitro Diagnostic Devices, with over 30 years of experience serving clients globally.
MDSS has been a leading Authorized Representative and Regulatory Affairs specialist for Medical and In Vitro Diagnostic Devices for over 30 years. They offer comprehensive In-Country Representation services across the EU, United Kingdom, Switzerland, USA, and Australia, acting as European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, U.S. Agent & Australian TGA Sponsor. This allows non-EU based companies to place their devices on these markets while focusing on innovation. Specifically for the Swiss market, MDSS acts as the Swiss Authorized Representative (CH-REP), a requirement for manufacturers located outside Switzerland to place their devices according to the MedDO and IvDO regulations. MDSS guides clients through regulatory requirements with Swissmedic and Swissdamed registration, serving as the primary contact for Swiss authorities regarding formal and safety-related issues. MDSS also assists with compliance for new regulations such as the AI ACT and GPSR, appointing them as your EU Representative to meet these mandates. They are committed to helping manufacturers navigate complex regulatory landscapes and ensure compliance with evolving standards.
About
**Who they are**
MDSS is a specialized provider of Authorized Representative and Regulatory Affairs services for Medical and In Vitro Diagnostic Devices, with over 30 years of global experience. They act as a pivotal contact for regulatory authorities.
**Expertise & scope**
* Serves as the Swiss Authorized Representative (CH-REP), a requirement for non-Swiss manufacturers placing medical devices on the Swiss market according to MedDO and IvDO.
* Acts as the main contact for Swiss authorities regarding formal and safety-related issues for medical devices.
* Guides manufacturers through regulatory requirements of Swissmedic and Swissdamed registration.
* Provides representation for clients to European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Offers services as European and Swiss Authorized Representative, UK Responsible Person, U.S. Agent, and Australian Sponsor.
* Services are an extension of a client's quality system, fulfilling regulatory obligations in the EU, UK, Switzerland, USA, and Australia.
**Reputation / proof points**
* Over 30 years of experience serving clients globally.
* Member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech, and the Medical Technology Association of Australia (MTAA).
* Maintains offices in Germany, USA, and UK, with a presence in Switzerland.
MDSS is a specialized provider of Authorized Representative and Regulatory Affairs services for Medical and In Vitro Diagnostic Devices, with over 30 years of global experience. They act as a pivotal contact for regulatory authorities.
**Expertise & scope**
* Serves as the Swiss Authorized Representative (CH-REP), a requirement for non-Swiss manufacturers placing medical devices on the Swiss market according to MedDO and IvDO.
* Acts as the main contact for Swiss authorities regarding formal and safety-related issues for medical devices.
* Guides manufacturers through regulatory requirements of Swissmedic and Swissdamed registration.
* Provides representation for clients to European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Offers services as European and Swiss Authorized Representative, UK Responsible Person, U.S. Agent, and Australian Sponsor.
* Services are an extension of a client's quality system, fulfilling regulatory obligations in the EU, UK, Switzerland, USA, and Australia.
**Reputation / proof points**
* Over 30 years of experience serving clients globally.
* Member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech, and the Medical Technology Association of Australia (MTAA).
* Maintains offices in Germany, USA, and UK, with a presence in Switzerland.
Additional information
MDSS supports manufacturers in navigating the specific requirements for the Swiss market, including registration with Swissmedic and Swissdamed. As the appointed Swiss Authorized Representative (CH-REP), they are the primary point of contact for Swiss authorities, managing formal and safety-related aspects of placing devices on the market. This role is crucial for manufacturers located outside Switzerland seeking to comply with the MedDO and IvDO regulations. Their services are designed to integrate with a client's existing quality system, ensuring comprehensive regulatory compliance across multiple international markets.
Key Highlights
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MDSS has over 30 years of experience in regulatory affairs for medical and IVD devices.
Source
“with over 30 years of experience serving clients globally.”
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MDSS acts as the Swiss Authorized Representative (CH-REP), a key requirement for placing devices on the Swiss market.
Source
“Place your devices in the Swiss market with MDSS as your Swiss Authorized Representative (CH-REP)!”
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They are a member of key industry associations including EAAR, UKRPA, Swiss Medtech, and MTAA.
Source
“MDSS is a member of the European Association of Authorized Representatives (EAAR), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).”
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MDSS provides representation services in multiple regions including EU, UK, Switzerland, USA, and Australia.
Source
“Our specialized expertise in European Regulatory Affairs positions us as your unparalleled Authorized Representative, providing a distinguished address in the EU, UK, Switzerland, USA, and Australia.”
Certifications & Trust Signals
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MDSS is a member of the European Association of Authorized Representatives (EAAR).
Source
“MDSS is a member of the European Association of Authorized Representatives (EAAR)”
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MDSS is a member of the UK Responsible Person Association (UKRPA).
Source
“the UK Responsible Person Association (UKRPA)”
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MDSS is a member of Swiss Medtech.
Source
“Swiss Medtech”
Buyer Snapshot
Best for
- Medical and IVD device manufacturers outside Switzerland needing a CH-REP.
- Companies seeking a single point of contact for Swiss regulatory affairs.
- Businesses requiring representation for EU, UK, USA, and Australia in addition to Switzerland.
How engagement typically works
- Proactive guidance through regulatory requirements.
- Direct liaison with Swiss authorities.
- Integration with client's quality systems.
Typical deliverables
- Swiss Authorized Representative (CH-REP) services.
- Support for Swissmedic and Swissdamed registration.
- Management of formal and safety-related issues.
- Regulatory compliance across multiple international markets.
Good to know
- Best when manufacturers are located outside Switzerland.
- Requires clear communication regarding device specifics and regulatory history.
Pricing
Model:
Retainer
Public range:
Publicly listed: $499–$999 / month
Notes:
Based on publicly listed information; final fees depend on scope.
“$499Per Month; $699Per Month; $999Per Month”
HQ:
Aarau, DE
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:
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, IVD
Swiss Local Contact:
Yes
Can Be Named On Label:
Yes
Vigilance Contact Support:
Yes
Swiss Entity Canton Or Region:
Aargau (Aarau)
Labeling Support:
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
MDSS guides manufacturers through regulatory requirements and registration processes with Swissmedic and Swissdamed.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I Medical Devices
Supports MDR
Yes
Supports IVDR
Yes
Swiss Entity Canton Or Region
Aarau
Labeling Support
Yes
Swiss Local Contact
Yes
Vigilance Contact Support
Yes
Can Be Named On Label
Yes
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