★ European Authorized Representative (EC REP) according to the MDR 2017/745 and IVDR 2017/746

★ U.S. Agent to the FDA

★ UK Responsible Person (UKRP) according to the UK MDR 2002

★ Swiss Authorized Representative (CH-REP) according to the MedDO and IvDO

★ Australian TGA Sponsor

In-Country Representation service
  • 1st European Authorized Representative
  • 30 years of experience
  • Market leader in EU, UK, Switzerland and in FSC

Take advantage of our In-Country Representation services for Medical Devices and In Vitro Diagnostic Devices

eu icon

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

U.S. AGENT SERVICES TO THE FDA

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

UKRP SERVICES UK RESPONSIBLE PERSON

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

SWISS AUTHORIZED REPRESENTATIVE

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

Australia

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

Free Online Seminar

Understanding local representative requirements

News and Views

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

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

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.

Other Services

mdss cosmetics

COSMETICS

MDSS Cosmetics provides services as Responsible Person for the Cosmetics Representation with the EU, UK and U.S. Authorities through the Cosmetics Regulations.

MDSS: Your trusted partner for comprehensive regulatory support and In-Country Representation!

MDSS is a market leader in the EU, UK and Switzerland with 30 years of experience providing In-Country Representation. We offer an integrated service designed to reduce complexity, save time, and cut costs.

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

X