★ European Authorized Representative (EC REP) for medical devices according to CE Regulations (MDR 2017/745 and IVDR 2017/746)

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

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

★ Cosmetics Responsible Person

★ U.S. Agent to the FDA

★ Australian TGA Sponsor

MDSS slogan
  • 1st European Authorized Representative
  • 30 years of experience
  • Market leader in EU, UK, Switzerland and in FSC

Take advantage of our global Authorized Representative Services

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

MDSS import service

IMPORTER
OF PRODUCTS

MDSS-Impex GmbH
is a company located in Germany that places medical devices from a third country on the European Market according to the MDR (EU) 2017/745) and IVDR (EU) 2017/746

News and Views

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

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

Looking for support?

screen 2024

Online Seminars

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

list 2024

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 SPECIALIZES IN AUTHORIZED REPRESENTATION AND REGULATORY AFFAIRS - YOUR EU, UK, SWISS AUTHORIZED REPRESENTATIVE, AUSTRALIAN TGA SPONSOR AND U.S. AGENT

X