MDSS: Your trusted partner for

In-Country Representation &

comprehensive regulatory support!

Authorized Representative Services & Regulatory Consulting

With over 30 years of experience, MDSS is a leading Authorized Representative and Regulatory Consulting organization, headquartered in Germany with offices in the United States, the United Kingdom, Switzerland, and Australia.

In addition to providing In-Country Representation services across the EU, UK, Switzerland, USA, and Australia — helping streamline global market access through a single, reliable partner, so you can focus on your core business and innovation — we offer regulatory strategy consulting for medical devices and IVDs, support with pre-submissions and marketing authorization applications to the FDA, and assistance with EU MDR and EU IVDR compliance.

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).

In-Country Representation Services

European Authorized Representative (EC REP)

A European Authorized Representative (EU AR) is a legal entity or individual based in the European Economic Area (EEA) that acts as a liaison between non-EU manufacturers and EU regulatory authorities to ensure compliance with EU product regulations, such as CE marking requirements. They are responsible for maintaining technical documentation, handling regulatory inquiries, and cooperating with market surveillance authorities.

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EU Representative – GPSR

A GPSR EU Representative (General Product Safety Regulation EU Representative) is a legal entity or individual based in the European Union who represents non-EU manufacturers to ensure compliance with the EU General Product Safety Regulation (GPSR). This representative is responsible for ensuring product safety compliance, maintaining technical documentation, cooperating with market surveillance authorities, and acting as a contact point for regulatory matters within the EU market.

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EU Representative – GDPR

A GDPR EU Representative is a legal entity or individual based in the European Union (EU) who represents non-EU businesses that process personal data of individuals in the EU but do not have a physical presence there. The representative acts as a point of contact for data subjects and regulatory authorities, ensuring compliance with the General Data Protection Regulation (GDPR) and facilitating communication regarding data protection matters.

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Legal Representative for the Sponsor

According to Article 62.2 of the Regulation (EU) 2017/745, when the Sponsor of a clinical investigation (or clinical study) is based outside the EU, a Legal Representative for the Sponsor of clinical investigations within the EU must be appointed. The Legal Representative is responsible for handling all communication and ensuring adherence to the Sponsor obligations outlined in the Regulation.

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National Registration

MDSS provides notification services to meet additional registration requirements, which apply to you, in EU Member States including Italy, Spain, Portugal, Latvia, Greece, Slovakia, and Lithuania, among others. We expertly manage your registration by handling the products notification with the competent authorities in these countries.

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Free Sales Certificate

MDSS-Impex GmbH provides the most complete and fastest import process in Europe. Being part of MDSS ensures the high quality of service with 30 years of experience in the European Regulatory Affairs.

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Importer of products

MDSS-Impex GmbH provides the most complete and fastest import process in Europe. Being part of MDSS ensures the high quality of service with 30 years of experience in the European Regulatory Affairs.

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U.S. Agent

A U.S. Agent is a representative based in the United States who acts as a liaison between a foreign company and the U.S. Food and Drug Administration (FDA). This agent assists with regulatory communications, helps facilitate inspections, and receives official correspondence from the FDA on behalf of the foreign company.

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UK Responsible Person (UKRP)

A UK Responsible Person (UKRP) is a legal entity or individual based in the United Kingdom who represents a non-UK manufacturer to ensure their products comply with UK product regulations, such as UKCA marking requirements. The UKRP is responsible for registering products with the MHRA (for medical devices), ensuring compliance with UK laws, and cooperating with UK regulatory authorities for market surveillance and safety matters.

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Swiss Authorized Representative (CH-REP)

A Swiss Authorized Representative (CH-REP) is a legal entity or individual based in Switzerland that represents non-Swiss manufacturers to ensure compliance with Swiss regulations, particularly for medical devices and other regulated products. The CH-REP is responsible for registering products with Swiss authorities (such as Swissmedic), maintaining technical documentation, and acting as a liaison with market surveillance authorities to ensure product safety and regulatory compliance.

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Sydney Opera House and Harbour Bridge in bright sunlight, symbolizing Australia and global medical device market access

Australian TGA Sponsor

An Australian TGA Sponsor is a legal entity or individual based in Australia who represents a foreign manufacturer to ensure compliance with the Therapeutic Goods Administration (TGA) regulations. The sponsor is responsible for registering the product in the Australian Register of Therapeutic Goods (ARTG), ensuring ongoing regulatory compliance, and acting as the official liaison with the TGA for audits, recalls, and safety reporting.

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Other services

Regulatory consulting

Navigate the complexities of medical device and IVD regulations with a single trusted partner.
MDSS Consulting GmbH team offers comprehensive support—from initial strategy development to market launch and beyond—ensuring your products meet applicable requirements and reach the market efficiently.

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Cosmetics

Safety and legal compliance for cosmetic products

MDSS Cosmetics provides services as Responsible Person (RP) for the Cosmetics Representation in the EU and UK under the Cosmetics Regulations, and as U.S. Agent under the FDA Regulations—Modernization of Cosmetics Regulation Act (MoCRA).

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