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.
**Expertise & scope**
* Serves as the EU Representative for GDPR, as mandated by Article 27 of the GDPR for processors and controllers operating outside the EU that handle personal data of EU individuals.
* Acts as the primary point of contact for regulatory bodies including 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 legal representative for entities without an established presence in the EU, UK, or US.
**Reputation / proof points**
* 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).
* Over 30 years of experience in the field.
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.
**Expertise & scope**
* Serves as the EU Representative for GDPR, as mandated by Article 27 of the GDPR for processors and controllers operating outside the EU that handle personal data of EU individuals.
* Acts as the primary point of contact for regulatory bodies including 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 legal representative for entities without an established presence in the EU, UK, or US.
**Reputation / proof points**
* 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).
* Over 30 years of experience in the field.
Additional information
MDSS acts as a crucial liaison for companies needing to comply with GDPR Article 27. They are designated to be addressed by supervisory authorities and data subjects on all matters related to data processing, ensuring compliance with GDPR. This representation is particularly relevant for non-EU entities offering goods or services to EU residents or monitoring their behavior within the EU. MDSS's role ensures that these organizations have a designated contact point within the Union for all GDPR-related communications and compliance.
Key Highlights
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Specializes in EU Authorized Representation and In-Country Representation for Medical and In Vitro Diagnostic Devices.
Source
“MDSS is a leading Authorized Representative and In-Country Representation specialist for Medical and In Vitro Diagnostic Devices.”
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Provides EU Representative services for GDPR compliance under Article 27.
Source
“According to Article 27 of the GDPR, all Processors / Controllers operating outside the European Union (EU) who handle personal data of individuals within the EU and are offering goods or services to EU residents or monitoring their behavior within the EU, must appoint a EU Representative – General Data Protection Regulation (GDPR).”
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Offers representation in multiple key regions including 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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Has over 30 years of experience in regulatory compliance.
Source
“With over 30 years of experience, they ensure regulatory compliance for companies worldwide.”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies outside the EU needing a GDPR Article 27 Representative.
- Medical device manufacturers requiring EU Authorized Representation.
- Sponsors of clinical investigations without an EU establishment.
How engagement typically works
- Acts as the mandated representative for communication with authorities and data subjects.
- Provides a physical address and point of contact within the EU.
- Ensures ongoing compliance with regulatory obligations.
Typical deliverables
- Designated EU GDPR Representative.
- EU Authorized Representative services.
- UK Responsible Person services.
- Representation for clinical investigations.
Good to know
- Best when the buyer is a processor or controller operating outside the EU and handling personal data of EU individuals.
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. MDSS acts as the addressee for all communications with supervisory authorities and data subjects regarding data processing.
EU EEA Establishment
MDSS has an establishment in Hannover, Germany, and also lists addresses in Chicago, USA; Manchester, UK; and Aarau, Switzerland.
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