MDSS: Your trusted partner for
In-Country Representation &
comprehensive regulatory support!
Authorized Representative Services & Regulatory Consulting
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 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)
EU Representative – GPSR


EU Representative – GDPR
Legal Representative for the Sponsor


National Registration
Free Sales Certificate


Importer of products
U.S. Agent to the FDA


UK Responsible Person (UKRP)
Swiss Authorized Representative (CH-REP)


Australian TGA Sponsor
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.


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).