MDSS (Medical Device Safety Service)
MDSS GmbH
MDSS is a leading Authorized Representative and In-Country Representation specialist for Medical and In Vitro Diagnostic Devices. With over 30 years of experience, they ensure regulatory compliance for companies worldwide.
MDSS (Medical Device Safety Service) is a highly experienced provider of In-Country Representation and Regulatory Affairs services, specializing in Medical and In Vitro Diagnostic Devices. With over 30 years in business and a consistent presence for over two decades, MDSS acts as a trusted Authorized Representative for non-EU based companies seeking to place their devices on the EU market. They offer comprehensive services across the EU, UK, Switzerland, USA, and Australia, including acting as the European Authorized Representative, UK Responsible Person, Swiss Authorized Representative, U.S. Agent, and Australian TGA Sponsor. MDSS also provides representation for the Sponsor of Clinical Investigations, ensuring compliance with regulations like the MDR and IVDR. Furthermore, MDSS assists companies in complying with new regulations such as the AI Act and the General Product Safety Regulation (GPSR) by acting as their EU Representative. They are dedicated to helping clients navigate complex regulatory landscapes, allowing them to focus on innovation and core business activities.
About
**Who they are**
MDSS (Medical Device Safety Service) is a specialist in Authorized Representation and In-Country Representation, with over 30 years of experience ensuring regulatory compliance for medical and in vitro diagnostic devices globally.
**Expertise & scope**
* Serves as the EU Representative for GDPR, mandated to be addressed by supervisory authorities and data subjects on all issues related to processing, ensuring compliance with the regulation.
* Acts as the pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Provides representation in the EU, UK, Switzerland, USA, and Australia.
* Specializes in Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance.
* Offers representation for sponsors of clinical investigations, acting as the addressee for all communications with the sponsor.
**Reputation / proof points**
* Over 30 years of experience.
* 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).
* Offices in Germany, USA, UK, and Switzerland.
MDSS (Medical Device Safety Service) is a specialist in Authorized Representation and In-Country Representation, with over 30 years of experience ensuring regulatory compliance for medical and in vitro diagnostic devices globally.
**Expertise & scope**
* Serves as the EU Representative for GDPR, mandated to be addressed by supervisory authorities and data subjects on all issues related to processing, ensuring compliance with the regulation.
* Acts as the pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
* Provides representation in the EU, UK, Switzerland, USA, and Australia.
* Specializes in Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) compliance.
* Offers representation for sponsors of clinical investigations, acting as the addressee for all communications with the sponsor.
**Reputation / proof points**
* Over 30 years of experience.
* 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).
* Offices in Germany, USA, UK, and Switzerland.
Additional information
MDSS acts as a crucial intermediary for organizations operating outside the EU that handle personal data of EU residents, as required by GDPR Article 27. They are designated to communicate with supervisory authorities and data subjects, ensuring that the controller or processor complies with data protection regulations. This service is particularly relevant for medical device companies offering goods or services to EU residents or monitoring their behavior within the EU, who do not have an establishment in the Union. MDSS's extensive experience in regulatory affairs positions them to manage these complex compliance requirements effectively.
Key Highlights
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Over 30 years of experience in medical device regulatory compliance.
Source
“With over 30 years of experience, they ensure regulatory compliance for companies worldwide.”
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Serves as a pivotal contact for European and national competent authorities, including the MHRA and Swissmedic.
Source
“At MDSS, we redefine excellence as your Authorized Representative, serving as the pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.”
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Provides representation services in the 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.”
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Member of key industry associations including EAAR and 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).”
Certifications & Trust Signals
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Established presence with multiple international offices.
Source
“Schiffgraben 41, 30175 Hannover, Germany 6118 W. Lawrence Avenue, Chicago, IL 60630, USA 6 Wilmslow Road, Rusholme, Manchester M14 5TP, UK Laurenzenvorstadt 61, 5000 Aarau, Switzerland”
Buyer Snapshot
Best for
- Companies outside the EU needing a GDPR Article 27 Representative.
- Medical device and IVD manufacturers requiring EU Authorized Representation.
- Sponsors of clinical investigations without an EU establishment.
How engagement typically works
- Retainer-based services for ongoing representation.
- Project-based support for specific regulatory needs.
Typical deliverables
- Designated EU GDPR Representative.
- EU Authorized Representative services.
- UK Responsible Person services.
- Communication channel with EU supervisory authorities and data subjects.
- Regulatory compliance guidance for medical devices.
Good to know
- Best when the buyer has no establishment in the EU or UK and requires a local representative for regulatory compliance.
HQ:
Hannover, Germany
Languages:
English, German
Timezones:
UTC+1, UTC+2
Claim status:
Listed
Services & Capabilities
GDPR Article 27 EU/UK Representative
Jurisdictions:
EU
Onboarding time:
3–7 days
Pricing model:
Retainer
Included services:
Regulator contact point, DSAR forwarding, Medical device compliance expertise, Health data support
Coverage:
EU, United Kingdom, Switzerland, USA, Australia
Supports Special Category Data:
Yes
Supports Children Data:
Yes
Supports Health Data:
Yes
Dpa Available:
Yes
Dsar Workflow Support:
Full managed
Regulator Comms Handling:
Full handling
Subprocessor List Available:
No
Breach Notification SLA:
Custom
Additional gdpr_art27_rep Details
Coverage Details
EU, UK, Switzerland, USA, Australia
Onboarding Steps
The process involves designating MDSS in writing as the representative. They are mandated to be addressed by supervisory authorities and data subjects on all issues related to processing.
EU EEA Establishment
MDSS has an establishment in the EU (Hannover, Germany) and is therefore suitable to act as an EU Representative.
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