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.
* Guides manufacturers through regulatory requirements of Swissmedic and Swissdamed registration.
* Acts as the main contact for Swiss authorities regarding formal and safety-related issues for medical devices.
* Provides representation for European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Offers services as a European and Swiss Authorized Representative, UK Responsible Person, U.S. Agent, or Australian Sponsor.
* Specializes in European Regulatory Affairs.
**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.
* Guides manufacturers through regulatory requirements of Swissmedic and Swissdamed registration.
* Acts as the main contact for Swiss authorities regarding formal and safety-related issues for medical devices.
* Provides representation for European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Offers services as a European and Swiss Authorized Representative, UK Responsible Person, U.S. Agent, or Australian Sponsor.
* Specializes in European Regulatory Affairs.
**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 regulatory landscape of Switzerland, acting as the essential link between the manufacturer and Swiss authorities like Swissmedic. Their role as a Swiss Authorized Representative (CH-REP) is crucial for market access, ensuring compliance with Swiss regulations such as the MedDO and IvDO. They manage formal and safety-related aspects, facilitating the placement of medical and in vitro diagnostic devices into the Swiss market. This service is particularly vital for manufacturers located outside of Switzerland who need a local entity to fulfill these obligations.
Key Highlights
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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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Acts as the Swiss Authorized Representative (CH-REP), a key requirement for market access in Switzerland.
Source
“Place your devices in the Swiss market with MDSS as your Swiss Authorized Representative (CH-REP)!”
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Member of key industry associations including Swiss Medtech and EAAR.
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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Provides representation to multiple global regulatory bodies including Swissmedic, MHRA, and FDA.
Source
“serving as the pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.”
Certifications & Trust Signals
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Over 30 years of experience serving clients globally.
Source
“with over 30 years of experience serving clients globally.”
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Member of Swiss Medtech.
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).”
Buyer Snapshot
Best for
- Medical and IVD device manufacturers outside Switzerland needing market access.
- Companies seeking a dedicated Swiss Authorized Representative (CH-REP).
How engagement typically works
- Proactive regulatory guidance and support.
- Direct liaison with Swiss authorities.
Typical deliverables
- Swiss Authorized Representative (CH-REP) services.
- Guidance on Swissmedic and Swissdamed registration.
- Management of formal and safety-related issues for the Swiss market.
Good to know
- Best when manufacturers are located outside Switzerland and require a local representative.
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 for Swissmedic and Swissdamed registration. They act as the main contact for the Swiss Authority for formal and safety-related issues.
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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