MDSS

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

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

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

U.S. Agent to the FDA.

Our Services

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

U.S. AGENT SERVICES TO THE FDA

U.S. AGENT

U.S. AGENT
TO THE FDA

Non-U.S. Medical Device & Pharma Companies must designate a U.S. Agent to register with the FDA and access the US market.

MDSS USA LLC assists the US Registration required by the FDA

UKRP SERVICES UK RESPONSIBLE PERSON

UKRP

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

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

MDSS import service

IMPORTER

IMPORTER
OF PRODUCTS

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

MDSS cosmetics service

COSMETICS

COSMETICS
RESPONSIBLE PERSON

MDSS Cosmetics provides services as Authorized Representative and Responsible Person for the Cosmetics Representation with the EU and UK Authorities through the Cosmetics Regulations

MDSS News and Views

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

Authorized Representative for Medical Device Companies

An Authorized Representative is a person or a legal entity who by designation of a manufacturer acts on their behalf. Your Authorized Representative is the main contact for the National Competent Authorities. An Authorized Representative may be addressed by authorities and bodies, instead of the manufacturer themselves, with regards to the requirements of the Medical Devices Regulations

innovation

Choose your solution for the MDR (EU) 2017/745 / IVDR (EU) 2017/746.

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

  • Medical Devices (MDR/MedDO/UK MDR 2002)
  • In Vitro Diagnostic Devices (IVDR/IvDO/UK MDR 2002)
  • Other European Directives & Regulations (RoHS, PPE, EMC/LVD etc.)
  • Cosmetics
  • FDA

Looking for support?

ONLINE SEMINARS

Learn more about the MDR with our Seminars

GSPR Checklist

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

Other Services

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

  • Appointing MDSS as your European Authorized Representative (EC REP) will effectively put your company on the forefront of European Regulatory Requirements.
  • MDSS acts as UK Responsible Person (UKRP) and Swiss Authorized Representative (CH-REP) via our subsidiaries.
  • MDSS is also specialized in FDA and provides the U.S. Agent service.

MDSS - YOUR BEST ADDRESS!

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