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 various regulatory authorities, including Swissmedic.
**Expertise & scope**
* Serves as the Swiss Authorized Representative (CH-REP) for medical device and IVD manufacturers located outside Switzerland, as required by Swiss authorities under MedDO and IvDO.
* Facilitates market access to Switzerland by managing formal and safety-related issues connected with placing devices on the Swiss market.
* Provides guidance through regulatory requirements of Swissmedic and Swissdamed registration.
* Acts as the main contact point for Swiss Authorities.
* Offers services as an EU Authorized Representative, UK Responsible Person, U.S. Agent, and Australian Sponsor.
* Supports 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), UK Responsible Person Association (UKRPA), Swiss Medtech, and the Medical Technology Association of Australia (MTAA).
* Has offices in Germany, USA, and UK, with representation 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 various regulatory authorities, including Swissmedic.
**Expertise & scope**
* Serves as the Swiss Authorized Representative (CH-REP) for medical device and IVD manufacturers located outside Switzerland, as required by Swiss authorities under MedDO and IvDO.
* Facilitates market access to Switzerland by managing formal and safety-related issues connected with placing devices on the Swiss market.
* Provides guidance through regulatory requirements of Swissmedic and Swissdamed registration.
* Acts as the main contact point for Swiss Authorities.
* Offers services as an EU Authorized Representative, UK Responsible Person, U.S. Agent, and Australian Sponsor.
* Supports 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), UK Responsible Person Association (UKRPA), Swiss Medtech, and the Medical Technology Association of Australia (MTAA).
* Has offices in Germany, USA, and UK, with representation in Switzerland.
Additional information
MDSS emphasizes its role as a dedicated Swiss Authorized Representative (CH-REP), acting as the primary liaison with Swiss authorities like Swissmedic. For manufacturers outside Switzerland, appointing MDSS as CH-REP is crucial for placing medical devices and IVDs on the Swiss market, ensuring compliance with MedDO and IvDO regulations. Their service includes managing formal and safety-related aspects, thereby streamlining the market entry process. MDSS also provides support for Swissdamed registration, guiding clients through the necessary procedures.
Key Highlights
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MDSS has over 30 years of experience as an Authorized Representative and Regulatory Affairs specialist.
Source
“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.”
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MDSS acts as the Swiss Authorized Representative (CH-REP), managing formal and safety-related issues for market access.
Source
“As a Swiss Authorized Representative, MDSS is the main contact for the Swiss Authority and responsible for the formal and safety-related issues connected with the placing of medical devices in the Swiss market.”
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MDSS guides manufacturers through Swissmedic and Swissdamed registration requirements.
Source
“Our dedicated team will guide you through all the regulatory requirements of Swissmedic (Swiss Agency for Therapeutic Products) and Swissdamed registration.”
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MDSS is a 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).”
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), the UK Responsible Person Association (UKRPA), Swiss Medtech and the Medical Technology Association of Australia (MTAA).”
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MDSS is a member of the UK Responsible Person Association (UKRPA).
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 is a member of the Medical Technology Association of Australia (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).”
Buyer Snapshot
Best for
- Medical and IVD device manufacturers outside Switzerland seeking market access.
- Companies needing a Swiss Authorized Representative (CH-REP) to comply with MedDO and IvDO.
How engagement typically works
- Acts as the primary contact for Swiss authorities.
- Provides guidance on regulatory requirements and registration processes.
Typical deliverables
- Swiss Authorized Representative (CH-REP) services.
- Management of formal and safety-related issues for Swiss market entry.
- Support for Swissmedic and Swissdamed registration.
Good to know
- Best when a dedicated Swiss Authorized Representative is required for market access.
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
Find 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
Not explicitly stated, but services are for Medical Devices and IVDs.
Supports MDR
Yes, implied by EU Authorized Representative services and mention of MDR Article 93.
Supports IVDR
Yes, implied by EU Authorized Representative services and mention of IVDR.
Swiss Entity Canton Or Region
Aarau (based on address provided)
Labeling Support
Implied through Swiss Authorized Representative role for formal and safety-related issues.
Swiss Local Contact
Yes, indicated by the Aarau address and role as CH-REP.
Vigilance Contact Support
Yes, implied by the role as the main contact for the Swiss Authority for formal and safety-related issues.
Can Be Named On Label
Yes, implied by the role as Swiss Authorized Representative (CH-REP) and main contact for authorities.
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