★ 1st European Authorized Representative

★ More than 30 years in business

★ Same trusted address for 20+ years

For over 30 years, MDSS has been a trusted Authorized Representative specializing in Regulatory Affairs for Medical and In Vitro Diagnostics devices.

We offer comprehensive In-Country Representation across the EU, UK, Switzerland, USA, and Australia, designed to minimize complexity, save time, and reduce costs, allowing you to focus on your core business, including innovation.

MDSS Roadshow

Celebrating our 30th anniversary!

Logo 30 years

MDSS
In-Country Representation services

for Medical and
In Vitro Diagnostic Devices

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EC REP

EUROPEAN AUTHORIZED REPRESENTATIVE

Non-EU based Medical Devices Companies must appoint an EU Authorized Representative to place devices in the EU market. MDSS GmbH assists the EU Registration with the European Authorities

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EU REPRESENTATIVE

GSPR - GENERAL PRODUCT SAFETY REGULATION

Appoint MDSS as your EU Representative to comply with the Regulation (EU) 2023/988. Manufacturers not established in the European Union (EU) must designate an economic operator established in the EU for all their products.

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EU Rep GDPR

EU REPRESENTATIVE

GDPR - GENERAL DATA PROTECTION REGULATION

Appoint MDSS as your EU Representative to comply with the Regulation (EU) 2016/679. If Processors/Controllers located outside the European Union (EU), serve EU customers, a EU Representative for the GDPR is required.

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EU LEGAL REPRESENTATIVE

FOR CLINICAL INVESTIGATIONS

Where the Sponsor of a clinical investigation is based outside the European Union (EU), they must appoint a legal representative within the EU. This representative is responsible for ensuring the Sponsor's compliance with all obligations.

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NATIONAL REGISTRATION & GMDN CODE

Appoint MDSS to perform National Registrations on your behalf! MDSS also offers Global Medical Device Nomenclature (GMDN) code research.

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FREE SALES CERTIFICATE - FSC & CFS

The MDSS team provides the support during the whole process of applying for a Free Sales Certificate (FSC) / Certificate of Marketability in the EU, UK or Switzerland for non-European countries.

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Importer to the EU market

IMPORTER OF PRODUCTS

TO THE EUROPEAN MARKET

MDSS-Impex GmbH places devices from a third country on the European Market according to the European Regulations MDR (EU) 2017/745) and IVDR (EU) 2017/746.

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U.S. AGENT SERVICES TO THE FDA

U.S. AGENT

U.S. AGENT TO THE FDA

Non-U.S. Medical Device Companies must designate a U.S. Agent to register devices with the FDA and access the US market. MDSS USA LLC assists the US Registration required by the FDA

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UKRP SERVICES UK RESPONSIBLE PERSON

UK RP

UK RESPONSIBLE PERSON

Non-UK based Medical Devices Companies must appoint a UK Responsible Person to place devices in the UK market. MDSS-UK RP Ltd. performs and assists the UK Registration with the MHRA

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SWISS AUTHORIZED REPRESENTATIVE

CH-REP

SWISS AUTHORIZED REPRESENTATIVE

Non-Swiss based Medical Device Companies must appoint a Swiss Authorized Representative to place devices in the CH market. MDSS CH GmbH assists the Swiss Registration with Swissmedic

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Australia

AU SPONSOR

AUSTRALIAN TGA SPONSOR

Non-Australian based Medical Device Companies must appoint an Australian Sponsor to launch devices in the Australian market. MDSS AU performs and assists with the Registration required by the TGA

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MDSS is your In-Country Representative in the European Union, United Kingdom, Switzerland, USA and Australia for:

MDSS Consulting

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.

MDSS Cosmetics logo

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).

News and Views

The latest news and updates on medical devices in Europe and US

Looking for support?

Online Seminars

Learn more about the MDR and the IVDR with our Seminars.

GSPR Checklist

Will get you started to transition from MDD to MDR / IVDD to IVDR.

MDR Templates

Will support you by providing relevant document templates.

Partner with MDSS for seamless market access and expert regulatory guidance, ensuring a smooth and efficient entry into your target markets