MDSS group

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.

MDSS Services

  • 1st European Authorized Representative
  • More than 25 years of experience
  • Market leader in EU, UK, Switzerland and in FSC
eu icon

EC REP

EUROPEAN AUTHORIZED
REPRESENTATIVE

For Non-EU based Medical Devices Companies.
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

For Non-U.S. Medical Device & Pharma Companies.

MDSS USA LLC assists the US Registration required by the FDA

UKRP SERVICES UK RESPONSIBLE PERSON

UKRP

UK
RESPONSIBLE PERSON

For Non-UK based Medical Devices Companies.
MDSS-UK RP Ltd. performs and assists the UK Registration with the MHRA

SWISS AUTHORIZED REPRESENTATIVE

CH-REP

SWISS AUTHORIZED
REPRESENTATIVE

For Non-Swiss based Medical Device Companies.
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 Union market

MDSS cosmetics service

COSMETICS

COSMETICS
RESPONSIBLE PERSON

MDSS Cosmetics provides services 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

European Authorized Representative for Medical Device Companies

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

innovation

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

U.S. Agent for Medical Device & Pharmaceutical Companies.

A U.S. Agent is required by the FDA, if you are a non – U.S. based medical device manufacturer. Without a U.S. facility, you will be unable to register your facility, list your products, or submit the FDA marketing authorization applications without designating a U.S. Agent.

Swiss Authorized Representative for Medical Device Companies

Medical Device Manufacturers located outside Switzerland must appoint a Swiss Authorized Representative (CH-REP) to place devices in the Swiss market. The need for a CH-REP is now a requirement, according to the MedDO and IvDO. Select MDSS as Your CH-REP!

UK Responsible Person for Medical Device Companies.

Medical Device Manufacturers located outside the UK must appoint a UK Responsible Person to place devices in the UK market. Select MDSS as Your UK Responsible Person (UKRP)!
MDSS is ready to support Medical Device Manufacturers located outside the UK as trade with the UK has changed significantly. The need for a UK Responsible Person is now a requirement and MDSS understands the new UK marketplace.

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 EUROPEAN REPRESENTATION AND REGULATORY AFFAIRS - YOUR EU AND SWISS AUTHORIZED REPRESENTATIVE, UK RESPONSIBLE PERSON 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!

Covid-19 Notice

X