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 regulatory affairs specialist and Authorized Representative with over 30 years of experience, serving clients globally in the medical and in vitro diagnostic device sectors. They act as a pivotal contact for various regulatory authorities, including Swissmedic.
**Expertise & scope**
* Swiss Authorized Representative (CH-REP) services for medical device and IVD manufacturers located outside Switzerland, ensuring compliance with MedDO and IvDO.
* Primary contact for Swiss authorities regarding formal and safety-related issues for devices placed on the Swiss market.
* Guidance through Swissmedic and Swissdamed registration requirements.
* Representation to European Commission, National Competent Authorities, MHRA, and FDA.
* Services extend to the EU, UK, USA, and Australia.
**Reputation / proof points**
* Over 30 years of experience.
* Member of the European Association of Authorized Representatives (EAAR), UK Responsible Person Association (UKRPA), Swiss Medtech, and the Medical Technology Association of Australia (MTAA).
* Offices in Germany, USA, UK, and Switzerland.
MDSS is a regulatory affairs specialist and Authorized Representative with over 30 years of experience, serving clients globally in the medical and in vitro diagnostic device sectors. They act as a pivotal contact for various regulatory authorities, including Swissmedic.
**Expertise & scope**
* Swiss Authorized Representative (CH-REP) services for medical device and IVD manufacturers located outside Switzerland, ensuring compliance with MedDO and IvDO.
* Primary contact for Swiss authorities regarding formal and safety-related issues for devices placed on the Swiss market.
* Guidance through Swissmedic and Swissdamed registration requirements.
* Representation to European Commission, National Competent Authorities, MHRA, and FDA.
* Services extend to the EU, UK, USA, and Australia.
**Reputation / proof points**
* Over 30 years of experience.
* Member of the European Association of Authorized Representatives (EAAR), UK Responsible Person Association (UKRPA), Swiss Medtech, and the Medical Technology Association of Australia (MTAA).
* Offices in Germany, USA, UK, and Switzerland.
Additional information
MDSS provides comprehensive support for manufacturers needing to place medical devices and IVDs on the Swiss market. As the appointed Swiss Authorized Representative (CH-REP), they serve as the essential link between manufacturers and Swiss regulatory bodies like Swissmedic. This role involves managing formal and safety-related aspects of device placement. Their services are designed to navigate the complexities of Swiss regulations, including the MedDO and IvDO, and facilitate registration processes. MDSS also offers broader regulatory support across the EU, UK, USA, and Australia, positioning them as a versatile partner for global market access.
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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Acts as the primary contact for Swiss authorities for devices placed on the Swiss market.
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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Provides guidance on 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).”
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
- Acting as the primary point of contact for Swiss authorities.
- Providing guidance on regulatory requirements and registration.
Typical deliverables
- Swiss Authorized Representative (CH-REP) designation.
- Support for MedDO and IvDO compliance.
- Facilitation of Swissmedic and Swissdamed registration.
Good to know
- Best when manufacturers are located outside of 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
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
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
The website content does not detail specific onboarding steps, required documents, timelines, or setup processes.
Local Entity Details
Swiss-based legal entity available to act as CH-REP under MedDO/IvDO (seed summary).
Device Classes Supported
Class I
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
