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 Representative and In-Country Representation services, with over 30 years of experience. They serve as a pivotal contact for various regulatory bodies.
**Expertise & scope**
* Designation as an EU Legal Representative to ensure compliance with the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
* Appointed as a representative for sponsors of clinical investigations when the sponsor lacks an EU establishment.
* Acts as an EU Representative for the General Data Protection Regulation (GDPR), as mandated by Article 27, for processors and controllers operating outside the EU.
* Provides representation in the EU, UK, Switzerland, USA, and Australia.
* Serves as a UK Responsible Person and U.S. Agent.
**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).
MDSS (Medical Device Safety Service) is a specialist in Authorized Representative and In-Country Representation services, with over 30 years of experience. They serve as a pivotal contact for various regulatory bodies.
**Expertise & scope**
* Designation as an EU Legal Representative to ensure compliance with the Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).
* Appointed as a representative for sponsors of clinical investigations when the sponsor lacks an EU establishment.
* Acts as an EU Representative for the General Data Protection Regulation (GDPR), as mandated by Article 27, for processors and controllers operating outside the EU.
* Provides representation in the EU, UK, Switzerland, USA, and Australia.
* Serves as a UK Responsible Person and U.S. Agent.
**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).
Additional information
MDSS acts as a crucial liaison between companies and regulatory authorities such as the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA. Their services are designed to integrate with a client's quality system, ensuring adherence to regulatory obligations across multiple key markets. For GDPR Article 27 representation, they are mandated to be addressed by supervisory authorities and data subjects on all processing-related issues, ensuring compliance with the regulation.
Key Highlights
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MDSS has over 30 years of experience in regulatory compliance and representation.
Source
“With over 30 years of experience, they ensure regulatory compliance for companies worldwide.”
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They serve as a pivotal contact for the European Commission, National Competent Authorities, MHRA, Swissmedic, and FDA.
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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MDSS provides EU Representative services for GDPR, as required by 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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They are a member of the European Association of Authorized Representatives (EAAR) and 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).”
Certifications & Trust Signals
Buyer Snapshot
Best for
- Companies outside the EU needing a GDPR Article 27 Representative.
- Medical device manufacturers requiring an EU Authorized Representative.
- Sponsors of clinical investigations without an EU establishment.
How engagement typically works
- Acting as the primary point of contact for regulatory bodies.
- Ensuring compliance with specific regional regulations (GDPR, MDR, IVDR).
- Facilitating communication between clients and authorities.
Typical deliverables
- Designated EU Representative for GDPR.
- EU Legal Representative for MDR/IVDR compliance.
- UK Responsible Person services.
- US Agent services.
Good to know
- Best when a company lacks an establishment in the EU, UK, or US.
- Required for processors/controllers outside the EU handling EU resident data.
HQ:
Hannover, Germany
Languages:
English, German
Timezones:
UTC+1, UTC+2
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
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 on all issues related to processing for the purposes of ensuring compliance with GDPR.
EU EEA Establishment
MDSS has offices in Germany (Hannover), USA (Chicago), UK (Manchester), and Switzerland (Aarau).
